239 results on '"Interventional study"'
Search Results
2. Poor Activities of Daily Living Predict Future Weight Loss in Older Adults After Hospital Discharge—Secondary Analysis of a Randomized Trial.
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Eymundsdottir, Hrafnhildur, Blondal, Berglind S., Geirsdottir, Ólöf G., and Ramel, Alfons
- Abstract
This study examined whether participants with poor activities of daily living (ADLs) at hospital discharge had increased weight loss after 6 months of follow-up and whether nutrition therapy can prevent this weight loss. This dietary randomized controlled trial (N = 104) examined community-dwelling older adults (66–95 years) discharged from hospital and at risk for malnutrition, receiving either 6 months of nutrition therapy (intervention) or only standard care (control). ADL was assessed using seven questions on self-care based on the Katz et al.'s method. At discharge, 45 (43%), 36 (35%), and 23 (22%) had high, medium, and poor ADL, respectively, with no differences between the control and intervention groups according to chi-square test. Participants in the control group with poor ADL had significantly higher weight loss than participants with high ADL (age- and sex-adjusted analysis of covariance: 3.6 kg; 95% confidence interval [1.0, 6.1] kg, p =.007). No such difference was observed in the intervention group. Participants with poor ADL at hospital discharge develop lower body weight by around 3.5 kg 6 months later when compared with participants with high ADL. Receiving nutrition therapy could help older adults with poor ADL to maintain body weight after hospital discharge. [ABSTRACT FROM AUTHOR]
- Published
- 2025
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3. A pilot study for testing feasibility and preliminary influence of early intervention using text messaging for pressure ulcer prevention in individuals with spinal cord injury.
- Author
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Liu, Liang Q., Deegan, Rachel, Dunne, Hester, Knight, Sarah L., Allan, Helen T., and Gall, Angela
- Abstract
This pilot study assessed text messaging as an early intervention for preventing pressure ulcers (PrUs) in individuals with spinal cord injury (SCI) post-hospital discharge. Thirty-nine wheelchair-users discharged after acquiring a SCI, underwent randomisation into an intervention group (n = 20) with text messages and a control group (n = 19). All participants received standard post-discharge care and completed a skincare questionnaire before and 6-month after discharge. Primary outcomes included feasibility and acceptability of early intervention using text messaging, alongside performance, concordance, and attitudes toward skincare. Secondary outcomes measured perception and the incidence of PrUs. Baseline demographics were comparable between the intervention and control groups. Eight of 20 participants completed 6-month follow-up questionnaires in the intervention group, six participants completed the 6-month questionnaires in the control group,. Participants expressed high satisfaction with text messages, understanding of content, and increased confidence in preventing PrUs. At 6-month post-discharge, the intervention group showed improved prevention practices, heightened awareness of PrU risks, and increased perceived importance of prevention, which were not observed in the control group. However, there were no significant differences in PrU incidence, possibly due to the small sample size and short follow-up. The study demonstrates that using text messaging as an early intervention for PrU prevention in individuals with SCI is feasible and well-received. Preliminary results suggest a positive impact on participants' attitudes and practices, indicating the potential of text messaging to reduce PrU incidence. However, further research with larger samples and extended follow-up is crucial to validate these promising initial findings. • This is the first study evaluating feasibility of text messagings for PrU prevention in spinal cord injury patients. • Participants were highly satisfied with receiving and understanding text messages, recommending them for PrU prevention. • Participants receiving messages showed improved practices, awareness, and reduced barriers of PrU prevention post-discharge. • If future larger studies show significant results, this intervention could be a valuable tool in community healthcare. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Assessing the effectiveness of health belief model-based educational interventions on weight control intentions among Malaysians
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Sivasankari Raman, Guat See Ooi, and Siew Chin Ong
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Health belief model ,Educational intervention ,Weight control intention ,Interventional study ,Control group ,Intervention group ,Medicine ,Science - Abstract
Abstract Obesity and overweight are major health concerns, with a 19.7% prevalence among Malaysian adults, as reported in the 2019 National Health and Morbidity Survey. This study assessed the effectiveness of an educational intervention on weight control intention using the Health Belief Model (HBM). A quasi-experimental design was employed, involving 140 participants equally divided into an intervention group (IG) and a control group (CG). Post-intervention, the IG showed significant improvement in perceived self-efficacy in dieting (mean score 3.96 ± 0.85) compared to the CG (3.76 ± 0.86, p = 0.003). Perceived self-efficacy in exercise also increased in the IG (4.12 ± 0.52) compared to the CG (3.51 ± 0.94, p
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- 2024
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5. Improving access to utilize the healthcare services facilitated by ASHAs, ANMs and medical officers of PHC among scheduled tribe pregnant women: An interventional study
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Anju Damu Ade, Visweswara Rao Guthi, Nagaraj Kondagunta, D. S. Sujith Kumar, Ravisankar Deekala, Chandrasekhar Vallepalli, and T V D Prathyusha
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interventional study ,maternal health services ,tribal pregnant women ,utilization ,Medicine - Abstract
Introduction: Early marriages, early childbirth, low BMI and high incidence of anaemia are known factors for high maternal mortality among tribal pregnant women. MATERIALS AND METHODS: This was a mixed method study (qualitative and quantitative) undertaken to evaluate educational intervention package among tribal pregnant women in Chittoor District of Andhra Pradesh State in South India. A baseline household survey with the help of a semi-structured questionnaire was conducted in both intervention group (n = 109) and control group (n = 119) of ST habitations. An educational intervention was implemented through health education approach to bring about awareness and behavioural change among pregnant women regarding healthcare practices and utilization of health services. Qualitative data collection tool included semi-structured FGD. Quantitative data was analysed using SPSS version 26.0. Content analysis was done for qualitative data. Results: The findings of this study show that awareness and utilization with respect to various services facilitated by ASHAs, ANMs and medical officers are improved postintervention among tribal pregnant women, and the various reasons for non-utilization of services were lack of awareness, long distance of health facility, no transportation, poor socio-economic status, inadequate facilities at PHC, etc., Conclusion: This study shows that intervention to improve awareness and health services utilization, and continuous health education should be imparted to all the pregnant mothers. For this healthcare providers like ASHA and ANM and medical officers should be trained and motivated to educate the community.
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- 2024
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6. Impact of a Bundle of Interventions on the Spectrum of Parenteral Drug Preparation Errors in a Neonatal and Pediatric Intensive Care Unit.
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von Hobe, Sabine, Schoberer, Mark, Orlikowsky, Thorsten, Müller, Julia, Kusch, Nina, and Eisert, Albrecht
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NEONATAL intensive care units , *NEONATAL intensive care , *DRUG labeling , *PEDIATRIC intensive care , *CLINICAL trials - Abstract
Background/Objectives: This study aimed to evaluate the impact of a bundle of interventions on the error rates in preparing parenteral medications in a neonatal and pediatric intensive care unit (NICU/PICU). Methods: We conducted a prospective interventional study in a NICU/PICU in a tertiary university hospital as a follow-up to a prior study in the same setting. A clinical pharmacist and a pharmacy technician (PT) analyzed the workflow of drug preparation on the ward, identified high-alert medications, and defined a bundle of five interventions, which include the following: Drug Labeling: 1. EN ISO-DIVI labeling; Training: 2. Standardized preparation process on the ward; 3. eLearning Program; 4. Expert Consultations; and Location of Preparation: 5. Transfer of the preparation of high-alert medications and standardized preparations to the central pharmacy. After implementing the bundle of interventions, we observed the preparation process on the ward to evaluate if the implementation of the interventions had an impact on the quality of the drug preparation. Results: We observed 262 preparations in the NICU/PICU. Each single step of the preparation process was defined as an error opportunity. We defined seven error categories with an overall error opportunity of 1413. In total, we observed 11 errors (0.78%). The reduction in the overall error rate from 1.32% in the former study to 0.78% per preparation opportunity demonstrated that the implemented interventions were effective in enhancing medication safety. Conclusions: This study provides evidence that a bundle of interventions, including standardizing drug labeling, enhancing training, and centralizing the preparation of high-alert medications, can reduce medication errors in NICU/PICU settings. [ABSTRACT FROM AUTHOR]
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- 2024
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7. Antioxidant intake and its relationship with generalized anxiety disorder among adults.
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Rizk, Lucie, Khalil, Nour Abi, Zeidan, Rouba Karen, Tabangi, Myriam, Karaman, Mehmet Akif, Barake, Roula, and Nakhl, Sahar
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GENERALIZED anxiety disorder , *ANXIETY disorders , *CLINICAL trials , *MENTAL illness , *PREVENTIVE medicine - Abstract
Antioxidant intake may contribute to the prevention of numerous diseases, particularly those related to stress-induced psychiatric and stress disorders. The current study aimed to assess the relationship between daily antioxidant intake (DAI) and Generalized Anxiety Disorder (GAD) in adults. It also sought to investigate the correlation between the type of diet in conjunction with DAI and the scores on GAD 7-Item Scale in adults. A cross-sectional design was used to examine if DAI was lower in individuals with GAD; followed by an interventional study of 40 adults with severe GAD, who were exposed to higher DAI for a period of 6 weeks. The results indicated that participants with severe GAD had significantly lower levels of DAI compared to healthy controls (
p < 0.001). After 6 weeks of antioxidant supplementation, a significant decrease in GAD-7 scores of participants was observed (p < 0.001). The study found a significant negative relationship between DAI and GAD. [ABSTRACT FROM AUTHOR]- Published
- 2024
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8. Improving access to utilize the healthcare services facilitated by ASHAs, ANMs and medical officers of PHC among scheduled tribe pregnant women: An interventional study.
- Author
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Ade, Anju Damu, Guthi, Visweswara Rao, Kondagunta, Nagaraj, Kumar, D. S. Sujith, Deekala, Ravisankar, Vallepalli, Chandrasekhar, and Prathyusha, T V D
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PREGNANT women ,MEDICAL care use ,MATERNAL health services ,CLINICAL trials ,MEDICAL personnel - Abstract
ABSTRACT: Introduction: Early marriages, early childbirth, low BMI and high incidence of anaemia are known factors for high maternal mortality among tribal pregnant women. Materials and Methods: This was a mixed method study (qualitative and quantitative) undertaken to evaluate educational intervention package among tribal pregnant women in Chittoor District of Andhra Pradesh State in South India. A baseline household survey with the help of a semi-structured questionnaire was conducted in both intervention group (n = 109) and control group (n = 119) of ST habitations. An educational intervention was implemented through health education approach to bring about awareness and behavioural change among pregnant women regarding healthcare practices and utilization of health services. Qualitative data collection tool included semi-structured FGD. Quantitative data was analysed using SPSS version 26.0. Content analysis was done for qualitative data. Results: The findings of this study show that awareness and utilization with respect to various services facilitated by ASHAs, ANMs and medical officers are improved postintervention among tribal pregnant women, and the various reasons for non-utilization of services were lack of awareness, long distance of health facility, no transportation, poor socio-economic status, inadequate facilities at PHC, etc., Conclusion: This study shows that intervention to improve awareness and health services utilization, and continuous health education should be imparted to all the pregnant mothers. For this healthcare providers like ASHA and ANM and medical officers should be trained and motivated to educate the community. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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- View/download PDF
9. Guidelines-based therapeutic strategies for controlling hypertension in non-controlled hypertensive patients followed by family physicians in primary health care in Portugal: the GPHT-PT study.
- Author
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Polónia, Jorge and Marques Pereira, Raul
- Abstract
Purpose: In a prospective open study, with intervention, conducted in Primary Health Care Units by General Practitioners (GPs) in Portugal, the effectiveness of a single pill of candesartan/amlodipine (ARB/amlodipine), as the only anti-hypertension (anti-HTN) medication, in adult patients with uncontrolled HTN (BP > 140/or > 90 mm Hg), either previously being treated with anti-HTN monotherapies (Group I), or combinations with hydrochlorothiazide (HCTZ) (Group II), or not receiving medication at all (Group III), was evaluated across 12-weeks after implementation of the new therapeutic measure. Materials and methods: A total of 118 GPs recruited patients with uncontrolled HTN who met inclusion/exclusion criteria. Participants were assigned, according to severity, one of 3 (morning) fixed combination candesartan/amlodipine dosage (8/5 or 16/5 or 16/10 mg/day) and longitudinally evaluated in 3 visits (v0, v6 and v12 weeks). Office blood pressure was measured in each visit, and control of HTN was defined per guidelines (BP< 140/90 mmHg). Results: Of the 1234 patients approached, 752 (age 61 ± 10 years, 52% women) participated in the study and were assigned to groups according to previous treatment conditions. The 3 groups exhibited a statistically significant increased control of blood pressure after receiving the fixed combination candesartan/amlodipine dosage. The overall proportion of controlled HTN participants increased from 0,8% at v0 to 82% at v12. The mean arterial blood pressure values decreased from SBP= 159.0 (± 13.0) and DBP= 91.1 (± 9.6) at baseline to SBP= 132,1 (± 11.3) and DBP= 77,5 (± 8.8) at 12 weeks (p < 0.01). Results remained consistent when controlling for age and sex. Conclusion: In patients with uncontrolled HTN, therapeutic measures in accordance with guidelines, with a fixed combination candesartan/amlodipine, allowed to overall achieve HTN control at 12 weeks in 82% of previously uncontrolled HTN patients, reinforcing the advantages of these strategies in primary clinical practice. PLAIN LANGUAGE SUMMARY: What is the context? Arterial hypertension (HTN) represents the main risk factor for cause of death from cardiovascular disease (CV). Adequate control of hypertension reduces CV risk and significantly prevents CV events and associated morbidity and mortality. This requires patients' adherence and persistence in implemented treatment and the achievement of tension targets that are related to the reduction of CV risk. The latest international recommendations indicate that hypertension control is insufficient in most countries. In Portugal, hypertension control is <43% and a significant number of patients treated do not comply with the recommendations. What is new? In a prospective, interventional, and multicentre study, carried out by General Practitioners (GPs) in Primary Health Care Units across Portugal, the objective was to determine (i) whether the presence of uncontrolled hypertension results from non-compliance with the provisions of the recommendations and the Integrated Care Process (PAI) of the Direção Geral de Saúde (DGS), i.e. inappropriate use of monotherapies or inadequate low doses of combinations of antihypertensives, and (ii) whether the adjustment of hypertension therapies, favouring the schemes provided in the recommendations, allows adequate control of arterial hypertension, in previously uncontrolled patients, when these are closely monitored in a 12-week time period. What is the impact? When the guidelines' therapeutic protocol is followed, as established for each identified group of patients (monotherapy, hydrochlorothiazide, and no medication), results indicate a marked and statistically significant improvements in both SBP and DBP values and hypertension control across time. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Study protocol of the GRoningen early-PD Ambroxol treatment (GREAT) trial: a randomized, double-blind, placebo-controlled, single center trial with ambroxol in Parkinson patients with a GBA mutation
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O. Siemeling, S. Slingerland, S. van der Zee, and T. van Laar
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Ambroxol ,Disease modifying therapy ,GBA1 ,Glucocerebrosidase ,Interventional study ,Parkinson’s disease ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Abstract Background To date, no disease modifying therapies are available for Parkinson’s disease (PD). Since PD is the second most prevalent neurodegenerative disorder, there is a high demand for such therapies. Both environmental and genetic risk factors play an important role in the etiology and progression of PD. The most common genetic risk factor for PD is a mutation in the GBA1(GBA)-gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). The mucolytic ambroxol is a repurposed drug, which has shown the property to upregulate GCase activity in-vitro and in-vivo. Ambroxol therefore has the potency to become a disease modifying therapy in PD, which was the reason to design this randomized controlled trial with ambroxol in PD patients. Methods This trial is a single-center, double-blind, randomized, placebo-controlled study, including 80 PD patients with a GBA mutation, receiving either ambroxol 1800 mg/day or placebo for 48 weeks. The primary outcome measure is the Unified Parkinson’s Disease Rating Scale motor subscore (part III) of the Movement Disorder Society (MDS-UPDRSIII) in the practically defined off-state at 60 weeks (after a 12-week washout period). Secondary outcomes include a 3,4-dihydroxy-6-18F-fluoro-I-phenylalanine ([18F]FDOPA) PET-scan of the brain, Magnetic Resonance Imaging (with resting state f-MRI and Diffusion Tensor Imaging), GCase activity, both intra- and extracellularly, sphingolipid profiles in plasma, Montreal Cognitive Assessment (MoCA), quality of life (QoL) measured by the Parkinson’s Disease Questionnaire (PDQ-39) and the Non-Motor Symptom Scale (NMSS) questionnaire. Discussion Ambroxol up to 1200 mg/day has shown effects on human cerebrospinal fluid endpoints, which supports at least passage of the blood-brain-barrier. The dose titration in this trial up to 1800 mg/day will reveal if this dose level is safe and also effective in modifying the course of the disease. Trial registration NCT05830396. Registration date: March 20, 2023.
- Published
- 2024
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11. Study protocol of the GRoningen early-PD Ambroxol treatment (GREAT) trial: a randomized, double-blind, placebo-controlled, single center trial with ambroxol in Parkinson patients with a GBA mutation.
- Author
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Siemeling, O., Slingerland, S., van der Zee, S., and van Laar, T.
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MOVEMENT disorders ,PARKINSON'S disease ,DIFFUSION tensor imaging ,MONTREAL Cognitive Assessment ,RESEARCH protocols ,MAGNETIC resonance imaging - Abstract
Background: To date, no disease modifying therapies are available for Parkinson's disease (PD). Since PD is the second most prevalent neurodegenerative disorder, there is a high demand for such therapies. Both environmental and genetic risk factors play an important role in the etiology and progression of PD. The most common genetic risk factor for PD is a mutation in the GBA1(GBA)-gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). The mucolytic ambroxol is a repurposed drug, which has shown the property to upregulate GCase activity in-vitro and in-vivo. Ambroxol therefore has the potency to become a disease modifying therapy in PD, which was the reason to design this randomized controlled trial with ambroxol in PD patients. Methods: This trial is a single-center, double-blind, randomized, placebo-controlled study, including 80 PD patients with a GBA mutation, receiving either ambroxol 1800 mg/day or placebo for 48 weeks. The primary outcome measure is the Unified Parkinson's Disease Rating Scale motor subscore (part III) of the Movement Disorder Society (MDS-UPDRSIII) in the practically defined off-state at 60 weeks (after a 12-week washout period). Secondary outcomes include a 3,4-dihydroxy-6-18F-fluoro-I-phenylalanine ([
18 F]FDOPA) PET-scan of the brain, Magnetic Resonance Imaging (with resting state f-MRI and Diffusion Tensor Imaging), GCase activity, both intra- and extracellularly, sphingolipid profiles in plasma, Montreal Cognitive Assessment (MoCA), quality of life (QoL) measured by the Parkinson's Disease Questionnaire (PDQ-39) and the Non-Motor Symptom Scale (NMSS) questionnaire. Discussion: Ambroxol up to 1200 mg/day has shown effects on human cerebrospinal fluid endpoints, which supports at least passage of the blood-brain-barrier. The dose titration in this trial up to 1800 mg/day will reveal if this dose level is safe and also effective in modifying the course of the disease. Trial registration: NCT05830396. Registration date: March 20, 2023. [ABSTRACT FROM AUTHOR]- Published
- 2024
- Full Text
- View/download PDF
12. Introducing a pharmacist-led transmural care program to reduce drug-related problems in orthogeriatric patients: a prospective interventional study
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Bailly, Rachel, Wuyts, Stephanie, Toelen, Loic, Mets, Tony, Van Hauwermeiren, Carmen, Scheerlinck, Thierry, Cortoos, Pieter-Jan, and Lieten, Siddhartha
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- 2024
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13. Effectiveness of an intervention program on physical activity in children with narcolepsy type 1.
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Brunel, Lisa, Brossaud, Enzo, Lioret, Julien, Jaffiol, Antoine, Vanderghote, Louison, Cuisinier, Léa, Peter-Derex, Laure, Ricordeau, François, Thieux, Marine, Comajuan, Marion, Plancoulaine, Sabine, Guyon, Aurore, and Franco, Patricia
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CATAPLEXY , *PHYSICAL activity , *NARCOLEPSY , *LEISURE , *ATTENTION testing - Abstract
Physical activity (PA) is recommended as part of the management of narcolepsy type 1 (NT1). This study aimed at 1) characterizing PA in children and adolescents treated for NT1 using objective and subjective measurements, 2) evaluating how PA is associated with NT1 symptoms and comorbidities, and 3) evaluating the effects of an Adapted Physical Activity (APA) program on PA and clinical characteristics. Patients with NT1 from the National Reference Center of Narcolepsy (Lyon, France) were consecutively included in an APA intervention protocol. Narcolepsy symptoms and comorbidities were collected using standardized questionnaires and sustained attention was evaluated using the Bron-Lyon Attention Stability Test before and after the four-week APA intervention. PA was measured objectively using actigraphy throughout the study. Twenty-seven NT1 patients were included (median age 14.7 years [8.3–18.4], cataplexy 88.9%, obesity 37.0%). At baseline, 52.4% of the patients had satisfactory PA levels according to international recommendations. Patients with leisure-time PA (LTPA) showed higher quality of life than patients without. 45% of the patients increased PA during the intervention compared to baseline. These responsive patients had more depressive feelings and tended to have lower objective PA than non-responsive patients at baseline. No significant correlation was found between PA levels before and during the intervention and other clinical data. Most children with NT1 showed satisfying PA levels despite their daytime sleepiness. LTPA engagement was associated with higher quality of life. An APA intervention could be effective in children with narcolepsy, especially for those with depressive feelings. • More than half of the children with narcolepsy were physically active. • Those who engaged in leisure time physical activities showed higher quality of life. • Those with depression are particularly responsive to a physical activity program. [ABSTRACT FROM AUTHOR]
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- 2024
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14. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis
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Alejandro Balsa, Siegfried Wassenberg, Yoshiya Tanaka, Anne Tournadre, Hans-Dieter Orzechowski, Vijay Rajendran, Udo Lendl, Pieter-Jan Stiers, Chris Watson, Roberto Caporali, James Galloway, and Patrick Verschueren
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Body mass index ,Clinical trial ,DMARD ,Filgotinib ,Interventional study ,JAK inhibitor ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Introduction This post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib. Methods FINCH 1–3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according to Disease Activity Score 28 using C-reactive protein. The exposure-adjusted incident rate (EAIR) of adverse events (AEs) was assessed by baseline BMI, using integrated data from the FINCH 1–4 and the phase 2 DARWIN 1–3 studies (total filgotinib exposure = 8085 patient-years). Results Mean change from baseline in BMI over time was similar across treatment arms. In most patients, BMI increased by ≤ 1 or 2 kg/m2 at both weeks 12 and 24, regardless of treatment group or baseline BMI; few patients had increases of ≥ 4 kg/m2. For most efficacy measures, filgotinib 200 mg was more efficacious than filgotinib 100 mg or active comparators or placebo across BMI subgroups. For the higher filgotinib dose, the EAIR of serious treatment-emergent AEs, venous thrombotic and embolic events, and major adverse cardiovascular events increased with increasing BMI. Conclusions Filgotinib did not lead to substantial changes in BMI, and BMI did not appear to affect the efficacy of filgotinib. Trial Registration ClinicalTrials.gov identifiers: NCT02889796, NCT02873936, NCT02886728, NCT03025308, NCT01888874, NCT01894516, NCT02065700.
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- 2023
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15. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis.
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Balsa, Alejandro, Wassenberg, Siegfried, Tanaka, Yoshiya, Tournadre, Anne, Orzechowski, Hans-Dieter, Rajendran, Vijay, Lendl, Udo, Stiers, Pieter-Jan, Watson, Chris, Caporali, Roberto, Galloway, James, and Verschueren, Patrick
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BODY mass index ,MAJOR adverse cardiovascular events ,CLINICAL trials ,WEIGHT gain ,DISEASE remission - Abstract
Introduction: This post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib. Methods: FINCH 1–3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according to Disease Activity Score 28 using C-reactive protein. The exposure-adjusted incident rate (EAIR) of adverse events (AEs) was assessed by baseline BMI, using integrated data from the FINCH 1–4 and the phase 2 DARWIN 1–3 studies (total filgotinib exposure = 8085 patient-years). Results: Mean change from baseline in BMI over time was similar across treatment arms. In most patients, BMI increased by ≤ 1 or 2 kg/m
2 at both weeks 12 and 24, regardless of treatment group or baseline BMI; few patients had increases of ≥ 4 kg/m2 . For most efficacy measures, filgotinib 200 mg was more efficacious than filgotinib 100 mg or active comparators or placebo across BMI subgroups. For the higher filgotinib dose, the EAIR of serious treatment-emergent AEs, venous thrombotic and embolic events, and major adverse cardiovascular events increased with increasing BMI. Conclusions: Filgotinib did not lead to substantial changes in BMI, and BMI did not appear to affect the efficacy of filgotinib. Trial Registration: ClinicalTrials.gov identifiers: NCT02889796, NCT02873936, NCT02886728, NCT03025308, NCT01888874, NCT01894516, NCT02065700. Plain Language Summary: Some rheumatoid arthritis treatments cause patients to gain weight or are less effective in patients with obesity than in patients without obesity. Also, obesity can make rheumatoid arthritis worse. Filgotinib is a rheumatoid arthritis treatment that was evaluated in seven randomized clinical studies (FINCH 1–4 and DARWIN 1–3). We investigated whether filgotinib causes changes in weight and whether body mass index (BMI) affects the efficacy or safety of filgotinib. We analyzed how the BMI of patients who participated in FINCH 1, 2, or 3 changed over time. Most patients had a small increase in BMI (around 1–2 kg/m2 ) after 24 weeks of filgotinib treatment. This change in BMI was not affected by patients' BMI at baseline. Baseline BMI did not impact the efficacy of filgotinib, which was assessed using standard measures of disease activity. Filgotinib was more effective than other rheumatoid arthritis treatments and placebo in all patients, regardless of BMI subgroup. Using safety data from all seven clinical studies (FINCH 1–4 and DARWIN 1–3), we found that some adverse events occurred more often in patients with obesity (a BMI of ≥ 30 kg/m2 ) than in those without obesity. The increased adverse events included venous thrombotic and embolic events and major adverse cardiovascular events, for which obesity is a known risk factor. These results show that filgotinib did not substantially change BMI (which increased by around 1–2 kg/m2 in most patients), and that baseline BMI did not affect the efficacy of filgotinib. [ABSTRACT FROM AUTHOR]- Published
- 2023
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16. Class II composite restoration technique teaching: A randomised controlled crossover laboratory‐based trial involving a novel ringless sectional matrix technique.
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Bailey, Oliver, Shand, Bonnie, and Ellis, Ian
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CROSSOVER trials , *TEACHING methods , *MATRIX rings , *DENTAL education , *CLINICAL trials , *INTERNET surveys - Abstract
Introduction: Objectives were to assess how different techniques (including a novel ringless sectional matrix approach) affect students' restorative outcomes, and their preferences for and preparedness to clinically implement new techniques with the aim of introducing appropriate techniques to the undergraduate curriculum. Materials and Methods: Students performed two class II composite restorations in plastic teeth using two sectional matrix techniques (separating ring vs. without [ringless]), and two composite restorative techniques (incremental vs. injection‐moulded bulk‐fill). Restorations were assessed on multiple parameters which were combined to rate them as "good" or not. Online surveys assessed students' preferences for and preparedness to clinically implement new techniques. Results: Contact area concavity (OR = 106, p <.001) and cervical marginal overhang (OR = 7.4, p <.001) were much more likely with the separating ring compared to the ringless sectional matrix technique. "Good" restorations were 29.5 times more likely when using ringless compared to separating ring techniques and 3.3 times more likely when using the injection‐moulding bulk‐fill compared to layered composite technique. A majority of students preferred the ringless to separating ring sectional matrix technique and the injection‐moulding bulk‐fill to layered composite technique. Large majorities felt prepared to implement the new techniques clinically with no or minimal guidance. Conclusions: A classic sectional matrix technique with separating ring resulted in a much greater occurrence of contact area concavity and cervical marginal overhang than a novel ringless approach. When allied with student preferences and clinical preparedness, inclusion of the novel ringless approach in the undergraduate curriculum can be supported alongside bulk‐fill injection‐moulding techniques. [ABSTRACT FROM AUTHOR]
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- 2023
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17. Progress Report on the Spinal Cord Rehabilitation Research Initiatives Based on Registered Clinical Studies From 2000 to 2022.
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Furlan, Julio C., Furlan, Daniel T., and Marquez-Chin, Cesar
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SERVICES for caregivers , *BIOMARKERS , *SPINAL cord , *SPINAL cord injuries , *SYSTEMATIC reviews , *CONVALESCENCE , *SPINAL cord diseases , *CONTINUING education units , *MEDICAL technology , *CONTINUING medical education , *REHABILITATION of people with mental illness , *MEDICAL protocols , *DECISION making , *COMBINED modality therapy , *CLINICAL trial registries , *EXERCISE therapy , *MOTOR ability , *DISEASE complications - Abstract
The current rehabilitation therapy protocols for management of individuals with spinal cord injury or disease aim to maximize restoration of remaining function and minimize secondary health conditions. In addition, several novel rehabilitation therapies for management of spinal cord injury or disease have been reshaping the field over the past two decades. This scoping reviewanalyzes the trends and features of the recently completed and ongoing clinical studies on the rehabilitation of individuals with spinal cord injury or disease that were registered in the ClinicalTrials.gov Website. Furthermore, this in-depth review synthesizes and appraises what was learned and what will potentially be discovered in the near future from the clinical studies on the rehabilitation after spinal cord injury or disease. [ABSTRACT FROM AUTHOR]
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- 2023
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18. Effectiveness of Internet-based health management in patients with dyslipidemia: A four-year longitudinal study.
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Dou, Yuqi, Chen, Botian, Yu, Xue, and Ma, Defu
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DYSLIPIDEMIA , *HEALTH behavior , *BLOOD lipids , *LONGITUDINAL method , *BLOOD cholesterol - Abstract
Dyslipidemia is an important risk factor for coronary artery disease and stroke, and it has emerged as a major public health issue worldwide. Internet-based health management and intervention may offer a new approach to health management. This study was conducted to provide health guidance and education to people with dyslipidemia using an Internet health management platform and to assess the effectiveness of Internet health management and intervention in improving health-related behaviors and controlling blood lipids. Starting in 2013 (Baseline, N = 56,542), a Western longitudinal study in China was performed, and all interventional objects were provided with Internet health management. Health checkups were conducted annually, and questionnaires were administered every two years to analyze changes in health behaviors two years (2015) and four years (2017) following the intervention. In addition, factors affecting behavioral changes and lipid control were analyzed in the dyslipidemic population to understand the effectiveness and influencing factors of Internet health management on lipid control. By guiding interventional objects through the Internet health management platform, the awareness rate of dyslipidemia increased from 19.1% in 2013 to 34.4% in 2017; and the control rate of dyslipidemia increased from 9.1% at baseline to 18.5%. Certain health-related behaviors that are beneficial to health (tobacco use, physical activity, and partial dietary) were gradually improved over the intervention time. For patients with dyslipidemia, triglyceride decreased from 2.90 mmol/L (2013) to 2.77 mmol/L (2017) as the years went by. Analysis of factors affecting lipid control showed that non-compliance with health instructions affected lipid control; in addition to these, being female (0.722, 95% CI: 0.546,0.954) was found to be a protective factor for effective lipid control. The basic Internet-based health management platform in this study appears to be moderately successful and is a valuable and feasible application. Tobacco, dietary, and physical activity interventions provided significant protection against dyslipidemia in patients. [Display omitted] • Internet-based health management and intervention can improve the awareness rate and control rate of dyslipidemia. • By guiding individuals through the Internet health management platform, their health-related behaviors beneficial to health were gradually improved over the intervention time. • Serum cholesterol and triglyceride of patients with dyslipidemia decreased year by year over the intervention time. [ABSTRACT FROM AUTHOR]
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- 2023
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19. ClinicalTrials.gov
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Gresham, Gillian, Werther, Winifred, Section editor, Piantadosi, Steven, editor, and Meinert, Curtis L., editor
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- 2022
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20. Ethical review of real-world study
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E. A. Volskaya, A. L. Khokhlov, and D. Yu. Belousov
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real-world study ,real-world data ,ethical review ,ethical committee ,non-interventional study ,interventional study ,confidentiality ,personal data ,confounding ,Medicine (General) ,R5-920 - Abstract
This article is devoted to an ethical review of planned real-world studies. The legal basis of such examinations has also been considered. Most real-world studies are non-interventional, so the ethical review of such studies is similar to that of observational studies.
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- 2022
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21. Public disclosure of clinical trial results at Clinical Trial Registry of India- Need for transparency in research!
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Munshi, Renuka, Pilliwar, Chaitali, and Maurya, Miteshkumar Rajaram
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- *
CLINICAL trial registries , *CLINICAL trials , *MEDICAL disclosure , *MEDICAL personnel , *SCIENTIFIC community - Abstract
Introduction: Since June 15, 2009, clinical trial registration in the Clinical Trial Registry-India (CTRI) has been made mandatory by the Drugs Controller General of India to improve transparency, accountability, conform to accepted ethical standards and reporting of all relevant results of registered trials. In this study, we planned to evaluate the compliance of Indian and global sponsors with clinical trials conducted in India in terms of reporting of clinical trial results at the CTRI. Methods: We included trials registered in the CTRI between January 2018 and January 2020. The CTRI and ClinicalTrials.gov registry was thoroughly searched for all completed interventional studies. A year-wise comparative analysis was performed to evaluate the number of clinical trials reporting results in both the registry. Results: The reporting of completed interventional clinical trial results was 25/112 (22.32%) in year 2018, y, 8/105 (7.6%) in year 2019 and 17/140 (12.14%) in year 2020. There was significantly less reporting of results of Pharmaceutical company sponsored Interventional Studies-Indian at CTRI when compared with ClinicalTrials.gov registry for the year 2019 (odds ratio [OR]-0.17 (95% confidence interval [CI]: 0.08--0.36) and P < 0.0001) and year 2020 (OR-0.45 [95% CI: 0.24--0.82] and P < 0.01). The difference in results reported at CTRI was significantly low for Pharmaceutical company sponsored Interventional Studies-Global only for year 2019 (OR-0.09 [95% CI: 0.005--1.45] and P = 0.04) compared with ClinicalTrials.gov. Conclusion: There is a need to develop the culture of reporting clinical trial results in CTRI to strengthen the transparency in the research for overall benefit of public, health care professionals, and research community. [ABSTRACT FROM AUTHOR]
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- 2023
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22. Respiratory Infections Prevention in Rural Older Adults: An Interventional Study.
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Abdel-Aziz, Hassanat Ramadan and Atia, Nashwa Saber
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- *
COMPUTER software , *RESEARCH methodology , *RESPIRATORY infections , *FISHER exact test , *INTERVIEWING , *TREATMENT effectiveness , *PRE-tests & post-tests , *HEALTH literacy , *PATIENTS' attitudes , *T-test (Statistics) , *PEARSON correlation (Statistics) , *RANDOMIZED controlled trials , *HEALTH behavior , *CHI-squared test , *DESCRIPTIVE statistics , *QUESTIONNAIRES , *STATISTICAL sampling , *DATA analysis software , *RURAL population , *OLD age - Abstract
Respiratory tract infections are one of the major causes of morbidity and mortality in older adults. This quasi-experimental study aimed to evaluate the effect of an educational intervention on respiratory infections prevention (RIP) in rural older adults. The study sample composed of 80 older adults from a rural area, randomly assigned into two groups. The intervention group (n = 40) received ten 1-hour twice-weekly sessions and the control group (n = 40) received no intervention. Pre- and post-intervention assessments were done using measures of knowledge, attitudes, and practices regarding RIP. Chi-square test, Fisher's exact test, independent samples t -test, and paired t -test were used for data analysis. The study findings showed that the study intervention resulted in statistically significant improvements in the intervention group's knowledge, attitudes, and practices regarding RIP compared with the control group (p <.01). The educational intervention was effective and could be used to help rural older adults prevent respiratory infections. [ABSTRACT FROM AUTHOR]
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- 2022
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23. Metacognitive Strategies for Developing Complex Geographical Causal Structures—An Interventional Study in the Geography Classroom
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Johannes Heuzeroth and Alexandra Budke
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metacognitive strategies ,systemic thinking ,complex geographical causal structures ,problem solving ,interventional study ,Public aspects of medicine ,RA1-1270 ,Psychology ,BF1-990 - Abstract
This article examines the impact of applied metacognition on the development of geographical causal structures by students in the geography classroom. For that, three different metacognitive strategies were designed: a. action plan, activating meta-knowledge prior to problem-solving and simultaneously visualizing action steps for dealing with the task (A); b. circular thinking (C), a loop-like, question-guided procedure applied during the problem-solving process that supports and controls content-related and linguistic cognition processes; c. reflexion (R), aiming at evaluating the effectivity and efficiency of applied problem-solving heuristics after the problem-solving process and developing strategies for dealing with future tasks. These strategies were statistically tested and assessed as to their effectiveness on the development of complex geographical causal structures via a quasi-experimental pre-posttest design. It can be shown that metacognitive strategies strongly affect students’ creation of causal structures, which depict a multitude of elements and relations at a high degree of interconnectedness, thus enabling a contentually and linguistically coherent representation of system-specific properties of the human–environment system. On the basis of the discussion of the results, it will be demonstrated that metacognitive strategies can provide a significant contribution to initiating systemic thinking-competences and what the implications might be on planning and teaching geography lessons.
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- 2021
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24. The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study
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Sergey V Efimov, Natallia V Matsiyeuskaya, Olga V Boytsova, Lyudmila Yu Akhieva, Elena I Kvasova, Francisco Harrison, Yulia S Karpova, Anton Tikhonov, Nadezhda F Khomyakova, Tim Hardman, and Jean-François Rossi
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azoximer bromide (polyoxidonium®) ,covid-19 ,inflammation ,interventional study ,Therapeutics. Pharmacology ,RM1-950 - Abstract
A clinical need for aetiotropic coronavirus disease (COVID-19) treatments is required. The immune modulator azoximer bromide (AZB; Polyoxidonium®) is indicated in Russia for use against acute viral infections and during remission. In this study, adults hospitalized with COVID-19 (n=32) received AZB and standard of care in an open-label, multicentre, interventional study. All patients were symptomatic; 22 had severe disease (National Early Warning Score ≥5) and required mechanical ventilation or respiratory support and 19 patients had co-morbidities. Patients received AZB 12 mg intravenously once daily for 3 days, then intramuscularly every other day (approximately ten injections) until discharge. The primary endpoint was the patient’s clinical status (7-point Ordinal Scale; OS) on day 15 versus that at baseline. The mean duration of hospitalization was 20 days. All patients were alive and discharged with normal oxygen saturation (SpO2) with no secondary infections or delayed mortality reported by the end-of-study visit (on day 28–72). A decrease in the mean OS and National Early Warning Score values was observed following treatment with AZB. A decrease in OS score was marked in patients identified as severe. Both sets of patients achieved similar scores, which can be classified as an improvement by day 9–10; SpO2 levels trended to normalization over time. By day 11–12, all patients had a normal body temperature. Serum C-reactive protein levels decreased in patients with severe and mild disease. Most patients had signs of pneumonia at baseline (n=27), with the majority recovering by days 10–12. No major toxicities were observed. AZB was safe and well tolerated when administered in addition to standard of care treatment for COVID-19. Further randomized, placebo-controlled studies are needed to elucidate any potential therapeutic effect in COVID-19.
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- 2021
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25. Sunscreen use: a theory-based interventional study using HAPA
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Panahi, Hadiseh, Keikavoosi-Arani, Leila, and Salehi, Leili
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- 2020
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26. Promoting physical activity among university students with a co-constructed program during Covid-19 pandemic
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A. Goncalves, M. Deshayes, C. Bernal, K. Korchi, M. Nogrette, B. Gisclard, and E. Charbonnier
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physical activity ,co-construction ,University student ,interventional study ,Psychiatry ,RC435-571 - Abstract
Introduction Since the beginning of the COVID-19 pandemic, sanitary context and e-learning has greatly modified students’ lifestyles. An increase of sedentary behaviors, a reduction in physical activity (PA) and a stronger tendency to move towards unhealthy diet have been demonstrated. Most of the research is largely descriptive and to date, no interventional studies have been conducted to prevent the deterioration of students’ health. Objectives The objective of the present research aims to evaluate the effects of an intervention program on the lifestyle and psychological state of student. Its primary objective is to promote PA among students, to improve both physical condition and motivation to engage in physical activity for one’s health by promoting motivational levers. Its second objective is to reduce and/or prevent the deterioration of the health of university students. Methods Students from University of Nîmes were recruited and randomly assigned to one of the two following conditions: an experimental group and a control group. The experimental group participated to an 8-weeks program of PA (co-constructed by users during design-based innovative workshops) whereas the control group did not. For each group, measures of PA, sedentary time, anthropometric data, sleep, physical condition and psychological variables (anxiety, depression, motivation, body appreciation, perceived control, well-being, …) were carried out before (T1: october 2021) and after (T2: December 2021) these 8-weeks in order to evaluate the benefits from the PA program. Results These assessments were performed in October 2021 (T1) and December 2021 (T2). Conclusions Data are still being collected and will be presented in April 2022. Disclosure No significant relationships.
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- 2022
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27. Blood pressure measurement knowledge and counselling among hospital pharmacists - an interventional study
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Aje, Akinniyi Akinbiyi and Adeyemo, Jumoke Oyeladun
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- 2023
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28. Wirkung technischer und biologischer Kontexte auf das situationale Interesse beim Bearbeiten physikalischer Lernaufgaben zum Energiekonzept
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Lewing, Johannes, Klein, Pascal, and Schneider, Susanne
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- 2023
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29. A Scoping Review of Registered Clinical Studies on Management of Individuals With Acute Spinal Cord Injury (2000-2020): Trends and Characteristics of the Research Initiatives.
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Furlan, Julio C. LLB, FRCPC, Furlan, Daniel T., and Marquez-Chin, Cesar
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- *
SPINAL cord injuries , *CLINICAL trials , *SCIENTIFIC observation , *SYSTEMATIC reviews , *ACUTE diseases - Abstract
This scoping review examined the current trends and characteristics of the clinical research initiatives on the management of acute spinal cord injury. This review included all clinical studies on the acute treatment of spinal cord injury that were registered in the ClinicalTrials.gov website from February 2000 to December 2020. The search strategy combined the terms "acute spinal cord injury" and "treatment." There has been a gradual increase in the number of registered clinical studies on acute treatment of spinal cord injury over the past two decades. Of the 116 studies, there were 103 interventional studies, 12 observational studies, and 1 registry. While 115 clinical studies recruited male and female participants, most of the registered clinical studies included only adults with an upper age limit after spinal cord injury. Most of the registered clinical studies were interventional studies led by single institutions in North America (n = 70), Europe (n = 29), and Asia (n = 15). Most of the research initiatives were interventional studies on new therapies for management of individuals with spinal cord injury (n = 91). In conclusion, the results of this scoping review suggest that although there has been an increase in the amount and diversity of the research initiatives on treatment of acute spinal cord injury over the past two decades, their generalizability remains relatively limited. [ABSTRACT FROM AUTHOR]
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- 2022
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30. Introducing virtual reality therapy for inpatients with dementia admitted to an acute care hospital: learnings from a pilot to pave the way to a randomized controlled trial
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Lora Appel, Erika Kisonas, Eva Appel, Jennifer Klein, Deanna Bartlett, Jarred Rosenberg, and Christopher Smith
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Non-pharmacological therapy ,Dementia ,Head-mounted display ,Interventional study ,Protocol ,Simulation ,Medicine (General) ,R5-920 - Abstract
Abstract Background Behavioural and psychological symptoms of dementia (BPSD) are difficult to manage, particularly in acute care settings. As virtual reality (VR) technology becomes increasingly accessible and affordable, there is growing interest among clinicians to evaluate VR therapy in hospitalized patients, as an alternative to administering antipsychotics/sedatives or using physical restraints associated with negative side effects. Objectives Validate and refine the proposed research protocol for a randomized controlled trial (RCT) that evaluates the impact of VR therapy on managing BPSD in acute care hospitals. Special attention was given to ascertain the processes of introducing non-pharmacological interventions in acute care hospitals. Methods Ten patients 65 years or older (mean = 87) previously diagnosed with dementia, admitted to an acute care hospital, were recruited over 3-month period into a prospective longitudinal pilot study. The intervention consisted of viewing 20-min of immersive 360° VR using a head-mounted display. Baseline and outcomes data were collected from the hospital electronic medical records, pre/post mood-state questionnaires, Neuropsychiatric Inventory (NPI) score, and standardized qualitative observations. Comprehensive process data and workflow were documented, including timestamps for each study task and detailed notes on personnel requirements and challenges encountered. Results Of 516 patients admitted during the study, 67 met the inclusion/exclusion criteria. In total, 234 calls were initiated to substitute decision makers (SDM) of the 67 patients for the consenting process. Nearly half (45.6%) of SDMs declined participation, and 40% could not be reached in time before patients being discharged, resulting in 57 eligible patients not being enrolled. Ten consented participants were enrolled and completed the study. The initial VR session averaged 53.6 min, largely due to the administration of NPI (mean = 19.5 min). Only four participants were able to respond reliably to questions. Seven participants opted for additional VR therapy sessions; of those providing feedback regarding the VR content, they wanted more varied scenery (animals, fields of flowers, holiday themes). Few sessions (4/18) encountered technical difficulties. Conclusion The pilot was instrumental in identifying issues and providing recommendations for the RCT. Screening, inclusion criteria, consenting, data collection, and interaction with SDMs and hospital staff were all processes requiring changes and optimizations. Overall, patients with dementia appear to tolerate immersive VR, and with suggested protocol alterations, it is feasible to evaluate this non-pharmacological intervention in acute care hospitals.
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- 2020
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31. Improving knowledge, self-efficacy and collective efficacy regarding the Brazilian dietary guidelines in primary health care professionals: a community controlled trial
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C. R. Tramontt and P. C. Jaime
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Interventional study ,Capacity building ,Food guides ,Health personnel ,Primary health care ,Medicine (General) ,R5-920 - Abstract
Abstract Background Capacity-building of health professionals regarding to nutrition is a strategy for qualifying public health work to promote healthy diets in primary health care (PHC) services. Objective To evaluate the effect of an intervention based on Brazilian Dietary Guidelines (BDG) on the knowledge, self-efficacy (SE) and collective efficacy (CE) of interprofessional teams working in PHC. Methods It refers to a pre-post intervention study involving 24 health professionals divided into a control group (CG) and intervention (IG). The IG received a 16-h educational workshop on the BDG, guided by a validated protocol. Knowledge, SE and CE for using the BDG were assessed via a self-administered scale, ranging from 0 to 16 and 0 to 36 points, respectively; the scale was previously validated, completed before and after 2 months of the intervention. The effects of the intervention were estimated by paired t-test for intragroup comparisons over time. Results The mean difference in the knowledge and SE scores of the IG pre- and post-intervention was 2.0 (CI 0.49–3.51) and 6.75 (CI 4.05–9.45) points, respectively. These results means the IG participants obtained 59 and 52.8% more points in knowledge and in SE in relation to CG, with significative difference (p = 0.007 and p
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- 2020
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32. Poor Activities of Daily Living Predict Future Weight Loss in Older Adults After Hospital Discharge-Secondary Analysis of a Randomized Trial.
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Eymundsdottir H, Blondal BS, Geirsdottir ÓG, and Ramel A
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- Humans, Aged, Female, Male, Aged, 80 and over, Geriatric Assessment methods, Malnutrition prevention & control, Nutrition Therapy methods, Patient Discharge, Weight Loss physiology, Activities of Daily Living
- Abstract
This study examined whether participants with poor activities of daily living (ADLs) at hospital discharge had increased weight loss after 6 months of follow-up and whether nutrition therapy can prevent this weight loss. This dietary randomized controlled trial (N = 104) examined community-dwelling older adults (66-95 years) discharged from hospital and at risk for malnutrition, receiving either 6 months of nutrition therapy (intervention) or only standard care (control). ADL was assessed using seven questions on self-care based on the Katz et al.'s method. At discharge, 45 (43%), 36 (35%), and 23 (22%) had high, medium, and poor ADL, respectively, with no differences between the control and intervention groups according to chi-square test. Participants in the control group with poor ADL had significantly higher weight loss than participants with high ADL (age- and sex-adjusted analysis of covariance: 3.6 kg; 95% confidence interval [1.0, 6.1] kg, p = .007). No such difference was observed in the intervention group. Participants with poor ADL at hospital discharge develop lower body weight by around 3.5 kg 6 months later when compared with participants with high ADL. Receiving nutrition therapy could help older adults with poor ADL to maintain body weight after hospital discharge.
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- 2024
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33. Reduced Clostridioides difficile infections in hospitalised older people through multiple quality improvement strategies.
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Dohrendorf, Carla Maria, Unkel, Steffen, Scheithauer, Simone, Kaase, Martin, Meier, Volker, Fenz, Diana, Sasse, Jürgen, Wappler, Manfred, Schweer-Herzig, Jutta, Friede, Tim, Reichard, Utz, Eiffert, Helmut, Nau, Roland, and Seele, Jana
- Subjects
- *
THERAPEUTIC use of probiotics , *CLOSTRIDIOIDES difficile , *HYGIENE , *CLOSTRIDIUM diseases , *COMPARATIVE studies , *RISK assessment , *GERIATRIC nursing , *HOSPITAL care of older people , *QUALITY assurance , *TIME series analysis , *CROSSOVER trials , *STERILIZATION (Disinfection) , *SPORES , *DISEASE risk factors - Abstract
Objectives To reduce infections with Clostridioides difficile (CDI) in geriatric patients by interventions easily implementable in standard clinical care. Methods Prevalence and incidence of CDI between January 2015 and February 2020 were analysed (n = 25,311 patients). Pre-intervention status was assessed from April 2016 to March 2017 (n = 4,922). Between May 2017 and August 2019, a monocentric interventional crossover study (n = 4,655) was conducted including standard care and three interventions: (A) sporicidal cleaning of hospital wards, (B) probiotics and (C) improvement in personal hygiene for CDI patients. This was followed by a multicentric comparison of the interventional bundle (A + B + C) between September 2019 and February 2020 (n = 2,593) with the pre-intervention phase. In 98 CDI cases and matched controls individual risk factors for the development of CDI were compared. Results Time series analyses of CDI cases revealed a reduction in the prevalence of CDI in all three participating centres prior to the multicentric intervention phase. In the monocentric phase, no effect of individual interventions on CDI prevalence was identified. However, an aggregated analysis of CDI cases comparing the pre-intervention and the multicentric phase revealed a significant reduction in CDI prevalence. Risk factors for the development of CDI included use of antibiotics, anticoagulants, previous stay in long-term care facilities, prior hospital admissions, cardiac and renal failure, malnutrition and anaemia. Conclusions The observed reduction in CDI may be attributed to heightened awareness of the study objectives and specific staff training. Individual interventions did not appear to reduce CDI prevalence. A further randomised trial would be necessary to confirm whether the bundle of interventions is truly effective. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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34. Dietary guidelines training may improve health promotion practice: Results of a controlled trial in Brazil.
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Tramontt, Cláudia Raulino, Maia, Tarsis de Mattos, Baraldi, Larissa Galastri, and Jaime, Patricia Constante
- Abstract
Background: The double burden of malnutrition points to an urgent need to develop strategies to promote healthy diets. Health professionals are key elements for health promotion and must be prepared to deal with these issues in health services. Aim: This study aimed to evaluate the impact of an educational intervention based on Brazilian Dietary Guidelines in the practice of multidisciplinary teams working in primary health care. Methods: A controlled trial comprising pre- and post-tests was conducted with four multidisciplinary healthcare teams. The intervention group received 16 hours of training on the Brazilian Dietary Guidelines. The professionals' practices were evaluated by direct observation, before and after the intervention, for two months at each timepoint. Data on dietary counselling were collected using a previously validated scale. The Kruskal-Wallis test was used for intragroup comparison at T0 versus T1, and the intergroup effects of the intervention were estimated by generalized linear regression analysis with a 95% confidence interval. Results: The regression with the interaction term between the intervention group and time showed a positive effect of the educational intervention on professionals' practices in the intervention group in the crude and adjusted models (coefficient = 1.36 and p = 0.020). Brazilian Dietary Guidelines application significantly increased in non-nutritionist professionals' practices (p = 0.007) and in activities not related to nutrition (p = 0.028) in the intervention group over time (T1-T0). No significant differences were found in the control group. Conclusion: The intervention proved to be effective in promoting changes in health professionals' practices, demonstrating the strength of the strategy for dissemination of nutrition guidelines in primary health care. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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35. Acceptance or rejection of biological restoration: An educational interventional study
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Dhanu G Rao, Raghavendra Havale, Namira Mohammad Karobari, Athira Mohan Latha, Manasa Nagaraj, Namratha Tharay, and S P Shrutha
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acceptance ,biological restorations ,children ,interventional study ,oral health education ,rejection ,Medicine - Abstract
Background: The quest for an ideal restorative material has led to the discovery of biological restoration that is, the use of natural tooth as a restorative material. Thus, the aim of the present study is to evaluate the knowledge about biological restorations and efficacy of health education. Materials and Methods: It was a questionnaire-based pre- and post-educational interventional study. Around 386 parents reported to the department and willing to participate were included in the study. Data were collected through a self-administered questionnaire. The study was carried out in three phases where the second being the health education by individual approach. The data were further subjected to statistical analysis. Result: Our study comprised of 117 (30.3%) fathers and 269 (69.7%) mothers. When enquired about the awareness of biological restoration and tooth banks 96.6% and 95.3% of the parents were unaware of it respectively. About the acceptance of biological restoration treatment before the intervention, only 26% of parents accepted the treatment. However, after the educational intervention, the acceptance increased to 93%. Conclusion: A lacuna exists as per the knowledge and awareness of biological restorations was concerned. Health education can be considered as a pioneering approach in the creation of awareness and there is an increased need to conduct such educational interventions to improve parents' attitudes.
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- 2020
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36. Effect of an educational intervention on breastfeeding knowledge and attitude among interns at Cairo University Hospital
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Ola A. Mostafa, Marwa R. Salem, and Ahmed M. Badr
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Breastfeeding ,Interns ,Education ,Knowledge ,Attitude ,Interventional study ,Arctic medicine. Tropical medicine ,RC955-962 ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Professional advice provided to mothers has an effective role on the prevalence and duration of breastfeeding. Previous studies showed that health care providers had defective knowledge and skills necessary to promote and support breastfeeding. Aim To assess breastfeeding-related knowledge and attitude among interns at Cairo University Hospital, before and after the provision of breastfeeding educational training sessions. Materials and methods The first phase was a cross-sectional study, conducted in Cairo University Hospital (Kasr Al Ainy) among 137 interns. The second phase was a pre-post interventional design. A pretested self-administered questionnaire was used to explore breastfeeding-related knowledge and attitude before, immediately after, and 3 months after breastfeeding educational sessions. Results Participants’ mean age was 23.7 ± 0.81, (range 22–27 years), with equally distributed males and females. The median total knowledge percent score was 56.4 (45.2–64.5). The highest median subtotal knowledge percent score was for effective feeding 100 (100–100), and the least median was for breast milk expression 20 (0:40). Participants’ knowledge improved after the educational intervention: The subtotal knowledge scores showed a statistically significant improvement immediately after and 3 months after the intervention in the following items: advantages for the baby, colostrum, duration, complementary feeding, and breast milk expression. The median total attitude percent score was 80 (74.1–83.5) and significantly improved immediately after the intervention. Conclusion Baseline knowledge and attitude scores among interns significantly improved after the intervention. Therefore, adoption of different curricular and extracurricular activities to improve breastfeeding knowledge and skills is required.
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- 2019
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37. Phase IV Trials: Interventional and Non-interventional Studies
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Uema, Deise, Yen, Cheng Tzu, Hinke, Axel, de Castro, Gilberto, Jr., Araújo, Raphael. L.C, editor, and Riechelmann, Rachel P., editor
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- 2018
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38. Effectiveness of Interventional Strategies in Modulating Knowledge and Attitude of Health Care Professionals for Promoting Organ Donation: A Study in Tertiary Care Public Hospital of North India.
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Mahajan, Pranay, Koushal, V., Chhabra, R., Dhaliwal, N., Pandey, N., and Kaur, R.
- Subjects
- *
MEDICAL personnel , *ORGAN donation , *HEALTH attitudes , *PUBLIC hospitals , *TERTIARY care - Abstract
Objective: To evaluate the impact of interventional "educational module" on knowledge and attitude regarding organ donation amongst resident doctors and nurses in the Institute of National Importance. Study Design: Interventional and prospective. Methods: We devised an interactive educational module covering various aspects of organ donation through a series of audiovisual lectures and information booklets. Resident doctors and nurses posted in those areas of the 1948-bedded Postgraduate Institute of Medical Education and Research (PGIMER), where head injury patients were treated and were subject to intervention using this module. The pre and postinterventional scores of their knowledge and attitude regarding organ donation were compared to find out impact of the intervention. Results: A total of 242 nurses and 87 resident doctors participated in this research. Higher knowledge score was observed preintervention amongst doctors as compared to nurses. Significant improvement was seen in total knowledge scores of both groups postintervention. Doctors had better scores for the "concept of organ donation," while nurses were more familiar with "procedures and protocols." Both had low knowledge about "clinical criteria for brain death" and "legal issues" preintervention which improved significantly postintervention. The positive impact of intervention was also observed on attitude in both categories. A significant impact of intervention was observed on overall propensity of doctors and nurses to promote organ donation, for pledging their own organs and for counseling of the patient/attendants on this cause. Conclusion: Scientifically designed educational modules have a promising role in improving awareness and attitude of health care professionals regarding organ donation and their propensity to be prospective donors, effective counselors, and advocates of organ donation. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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39. It is possible to develop the professional values of nurses.
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Kaya, Ayla and Dalgiç, Ayşegül Işler
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MEDICAL quality control , *EVALUATION of human services programs , *NURSING , *CLINICAL trials , *PROFESSIONAL employee training , *PATIENT satisfaction , *HUMAN services programs , *PRE-tests & post-tests , *T-test (Statistics) , *NURSES , *CHI-squared test , *JOB satisfaction , *RESEARCH funding , *NURSING ethics , *EDUCATIONAL outcomes - Abstract
Background: The awareness and development of professional values affect the quality of nursing care. This study is the first interventional study conducted to develop the professional values of nurses in a clinical setting. Objectives: The aim of this study is to determine the effect of a structured Professional Values Development Programme on the development of the professional values of nurses. Research design: This study was a non-randomised controlled trial that measured with pre-test and post-test. Data were collected by using an Individual Identification Form and the Nurses' Professional Values Scale–Revised. The intervention group was involved in a 12-week programme. Participants in the control group received the programme after all data had been collected. Data collection for both groups was conducted at baseline and a 12-week follow-up. Expert opinions were evaluated by the Kendall Coefficient of Correlation test. Chi-square tests and t -tests were used to evaluate group differences. This study was registered at ClinicalTrials.gov. Participants and research context: This study was conducted with 80 nurses (intervention group = 40, control group = 40). This study was conducted in paediatric clinics in two university hospitals in Turkey. Ethical considerations: In order to conduct this study, ethics committee approval was obtained. This study was performed according to the Helsinki Declaration. Participants were informed verbally and in writing, and informed consent was obtained by giving explanations. F indings: In the analysis, the two groups were similar in demographic variables. The only significant difference between the groups was between weekly working hours. Participants in the intervention group reported statistically significantly higher levels of professional values (p = 0.001) than those in the control group. Discussions and conclusions: This study provides evidence of the positive effectiveness of the Professional Values Development Programme in the development of professional values of clinical nurses. It also demonstrated the feasibility of implementing the programme with clinical nurses. [ABSTRACT FROM AUTHOR]
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- 2021
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40. Metacognitive Strategies for Developing Complex Geographical Causal Structures--An Interventional Study in the Geography Classroom.
- Author
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Heuzeroth, Johannes and Budke, Alexandra
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GEOGRAPHY education ,STUDENT attitudes ,COGNITION ,LINGUISTICS ,CLASSROOM environment - Abstract
This article examines the impact of applied metacognition on the development of geographical causal structures by students in the geography classroom. For that, three different metacognitive strategies were designed: a. action plan, activating meta-knowledge prior to problem-solving and simultaneously visualizing action steps for dealing with the task (A); b. circular thinking (C), a loop-like, question-guided procedure applied during the problem-solving process that supports and controls content-related and linguistic cognition processes; c. reflexion (R), aiming at evaluating the effectivity and efficiency of applied problem-solving heuristics after the problem-solving process and developing strategies for dealing with future tasks. These strategies were statistically tested and assessed as to their effectiveness on the development of complex geographical causal structures via a quasi-experimental pre-posttest design. It can be shown that metacognitive strategies strongly affect students' creation of causal structures, which depict a multitude of elements and relations at a high degree of interconnectedness, thus enabling a contentually and linguistically coherent representation of system-specific properties of the human-environment system. On the basis of the discussion of the results, it will be demonstrated that metacognitive strategies can provide a significant contribution to initiating systemic thinking-competences and what the implications might be on planning and teaching geography lessons. [ABSTRACT FROM AUTHOR]
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- 2021
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41. INTERVENTIONAL STUDY TO COMBAT OBESITY BY MEANS OF KINESIOLOGY
- Author
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Benedek Florian
- Subjects
obesity ,kinesiology ,interventional study ,Education ,Education (General) ,L7-991 - Abstract
Obesity influences not only the reducing of daily life quality, but also the disease susceptibility and an increased mortality through endocrine diseases, cardiovascular, digestive, and so on. Subjects with BMI that is higher than 32, have a general mortality twice higher compared to subjects with normal weight.To determine the mechanisms of obesity, there have been made numerous researches and there have been developed several hypotheses, among these, more discussed, being found two theories. One of them, „exogenous” theory considers obesity as a reason to an external cause of human body, a simple consequence of an excessive food intake, a overeating; the second theory, „endogenous”, considers obesity as a reason to disorders of the body itself, an intake disorder or the use of food from nervous or endocrine causes.
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- 2018
42. Post-authorization clinical trials
- Author
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D. Yu. Belousov
- Subjects
пострегистрационные клинические исследования ,постмаркетинговые исследования ,пострегистрационные исследования безопасности ,интервенционные исследования ,рандомизированное клиническое исследование ,надлежащая клиническая практика ,post-authorization clinical trial ,post-marketing study ,post-authorization safety studies ,interventional study ,randomized clinical trial ,good clinical practice ,Medical technology ,R855-855.5 ,Pharmacy and materia medica ,RS1-441 - Abstract
The article describes post-authorization clinical trials of medicinal products for medical use conducted by pharmaceutical manufacturers after state registration, in order to collect additional data on safety and efficacy, expand indications for use, and identify adverse reactions.
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- 2018
43. Qualifizierte Freiwillige als Patientenbegleiter nach einem Krankenhausaufenthalt – nationale Implikationen aus internationalen Erkenntnissen.
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Göhner, Anne, Bitzer, Eva Maria, and Kricheldorff, Cornelia
- Abstract
Copyright of Zeitschrift für Gerontologie und Geriatrie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2020
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- View/download PDF
44. Interventions to improve nurses' job satisfaction: A systematic review and meta‐analysis.
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Niskala, Jenni, Kanste, Outi, Tomietto, Marco, Miettunen, Jouko, Tuomikoski, Anna‐Maria, Kyngäs, Helvi, and Mikkonen, Kristina
- Subjects
- *
PSYCHOLOGICAL burnout prevention , *CINAHL database , *JOB satisfaction , *MEDLINE , *META-analysis , *MOTIVATION (Psychology) , *ONLINE information services , *PROFESSIONAL employee training , *SPIRITUALITY , *STRESS management , *WORK environment , *SYSTEMATIC reviews , *PROFESSIONAL identity , *EVIDENCE-based nursing , *DESCRIPTIVE statistics , *HOSPITAL nursing staff - Abstract
Aims: To identify current best evidence on the types of interventions that have been developed to improve job satisfaction among nurses and on the effectiveness of these interventions. Design: The systematic review is a quantitative systematic review and meta‐analysis following a profile‐likelihood random‐effects model. Data Sources: CINAHL, Medic, and Pubmed (Medline). Review Methods: PICOS eligibility criteria were used to select original studies published between 2003–2019. The articles were screened by title (N = 489), abstract (N = 61), and full‐text (N = 47). A total of 20 articles remained after the full‐text screening process and further assess on risk of bias. The screening process was conducted by two authors independently and finally agreed together. A meta‐analysis was performed to determine how the identified interventions influence nurses' job satisfaction. Results: The interventions were primarily educational and consisted of workshops, educational sessions, lessons, and training sessions. The postintervention differences between intervention and control groups in meta‐analysis revealed that two interventions significantly improved nurses' job satisfaction. Notably, the spiritual intelligence training protocol and Professional Identity Development Program were found to be effective in improving job satisfaction. Conclusion: Healthcare organizations and managers should consider implementing effective interventions to improve nurses' job satisfaction and reduce turnover. The results reported in this study highlight that nurse managers should focus on organizational strategies that will foster the intrinsic motivation of employees. Impact: The current nursing shortage and increased turnover intentions are proving to be a global problem. For this reason, it is imperative that nurse managers plan strategies to improve nurses´ job satisfaction. The effective interventions detected in this study are a first step for developing human resource strategies for healthcare organizations. These findings propose that extrinsic factors (e.g., salary and rewards) will never be as effective in maintaining job satisfaction as intrinsic factors (e.g., spiritual intelligence, professional identity, and awareness). [ABSTRACT FROM AUTHOR]
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- 2020
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45. Effectiveness of Interventional Strategies in Modulating Knowledge and Attitude of Health Care Professionals for Promoting Organ Donation: A Study in Tertiary Care Public Hospital of North India.
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Mahajan, Pranay, Koushal, V., Chhabra, R., Dhaliwal, N., Pandey, N., and Kaur, R.
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MEDICAL personnel ,ORGAN donation ,HEALTH attitudes ,PUBLIC hospitals ,TERTIARY care - Abstract
Objective: To evaluate the impact of interventional "educational module" on knowledge and attitude regarding organ donation amongst resident doctors and nurses in the Institute of National Importance. Study Design: Interventional and prospective. Methods: We devised an interactive educational module covering various aspects of organ donation through a series of audiovisual lectures and information booklets. Resident doctors and nurses posted in those areas of the 1948-bedded Postgraduate Institute of Medical Education and Research (PGIMER), where head injury patients were treated and were subject to intervention using this module. The pre and postinterventional scores of their knowledge and attitude regarding organ donation were compared to find out impact of the intervention. Results: A total of 242 nurses and 87 resident doctors participated in this research. Higher knowledge score was observed preintervention amongst doctors as compared to nurses. Significant improvement was seen in total knowledge scores of both groups postintervention. Doctors had better scores for the "concept of organ donation," while nurses were more familiar with "procedures and protocols." Both had low knowledge about "clinical criteria for brain death" and "legal issues" preintervention which improved significantly postintervention. The positive impact of intervention was also observed on attitude in both categories. A significant impact of intervention was observed on overall propensity of doctors and nurses to promote organ donation, for pledging their own organs and for counseling of the patient/attendants on this cause. Conclusion: Scientifically designed educational modules have a promising role in improving awareness and attitude of health care professionals regarding organ donation and their propensity to be prospective donors, effective counselors, and advocates of organ donation. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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46. Acceptance or rejection of biological restoration: An educational interventional study.
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Rao, Dhanu, Havale, Raghavendra, Karobari, Namira, Latha, Athira, Nagaraj, Manasa, Tharay, Namratha, and Shrutha, S
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PARENT attitudes ,HEALTH education - Abstract
Background: The quest for an ideal restorative material has led to the discovery of biological restoration that is, the use of natural tooth as a restorative material. Thus, the aim of the present study is to evaluate the knowledge about biological restorations and efficacy of health education. Materials and Methods: It was a questionnaire-based pre- and post-educational interventional study. Around 386 parents reported to the department and willing to participate were included in the study. Data were collected through a self-administered questionnaire. The study was carried out in three phases where the second being the health education by individual approach. The data were further subjected to statistical analysis. Result: Our study comprised of 117 (30.3%) fathers and 269 (69.7%) mothers. When enquired about the awareness of biological restoration and tooth banks 96.6% and 95.3% of the parents were unaware of it respectively. About the acceptance of biological restoration treatment before the intervention, only 26% of parents accepted the treatment. However, after the educational intervention, the acceptance increased to 93%. Conclusion: A lacuna exists as per the knowledge and awareness of biological restorations was concerned. Health education can be considered as a pioneering approach in the creation of awareness and there is an increased need to conduct such educational interventions to improve parents' attitudes. [ABSTRACT FROM AUTHOR]
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- 2020
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47. Bewegte Kitas durch Organisationsentwicklung: Ergebnisse des Projekts QueB.
- Author
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Müller, Christina, Foitzik, Elisabeth, and Hassel, Holger
- Abstract
Copyright of Prävention und Gesundheitsförderung is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2020
- Full Text
- View/download PDF
48. Corrigendum: The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study
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Sergey V Efimov, Natallia V Matsiyeuskaya, Olga V Boytsova, Lyudmila Yu Akhieva, Elena I Kvasova, Francisco Harrison, Yulia S Karpova, Anton Tikhonov, Nadezhda F Khomyakova, Tim Hardman, and Jean-François Rossi
- Subjects
azoximer bromide (polyoxidonium®) ,covid-19 ,inflammation ,interventional study ,Therapeutics. Pharmacology ,RM1-950 - Abstract
The authors wish to make the following corrections to their article: Efimov SV, Matsiyeuskaya NV, Boytsova OV, et al. Corrigendum: The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study. Drugs in Context 2021; 10: 2021-11-1. DOI: 10.7573/dic.2020-11-1
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- 2021
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49. Interventional Study on Improvement of Mothers Knowledge Regarding Danger Signs In Children Under-Five Years of Age: A Systematic Review of Literature.
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Sarkar, Baisakhi, Haldar, Anima, Mandal, Nirmal Kumar, and Poddar, Sandeep
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- *
HAZARD signs , *MOTHERS , *AGE groups , *KEYWORD searching - Abstract
Introduction: To make the world better, in 2015, 195 nations agreed with United Nations to accomplish few goals – Sustainable Development Goals. 3rd Goal is Good Health & Wellbeing. To achieve this good health and wellbeing, the UN set few targets -one of them is ending all preventable death under five years of age. To keep preventable death low among those under five years of age, mother’s need to make aware in the simplest way. Methods: A systematic review of literature and database searched with relevant keywords. Total 234 studies spanning over 2005-2019 has been reviewed. Analyzed from reviewed study it’s pertinent that mothers/caregivers need to make aware regarding danger signs in children under five years to keep morbidity and mortality low in this age group. Results: In searched 234 studies only 2 found interventional in design that too not on preventable danger signs, others are descriptive. Conclusion: Delay in the identification of danger signs in children and subsequent delay in decision making to seek treatment can make preventable disease fatal. So need more interventional studies to make mothers aware. [ABSTRACT FROM AUTHOR]
- Published
- 2022
50. Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study
- Author
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Lora Appel, Eva Appel, Orly Bogler, Micaela Wiseman, Leedan Cohen, Natalie Ein, Howard B. Abrams, and Jennifer L. Campos
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non-pharmacological therapy ,dementia ,head-mounted-display ,interventional study ,nature ,simulation ,Medicine (General) ,R5-920 - Abstract
Background: Older adults living in long term care, rehabilitation hospitals, and seniors' residences often experience reduced mobility, sometimes resulting in confinement indoors and isolation, which can introduce or aggravate symptoms of depression, anxiety, loneliness, and apathy. As Virtual Reality (VR) technologies become increasingly accessible and affordable, there is a unique opportunity to enable older adults to escape their restricted physical realities and be transported to both stimulating and calming places which may improve their general well-being. To date no robust evaluations of the use of immersive VR therapy [experienced through a head-mounted-display (HMD)] for older adults within these settings have been reported. VR-therapy may prove to be a safe, inexpensive, non-pharmacological means of managing depressive symptoms and providing engagement and enjoyment to this rapidly growing demographic.Objectives: Establish whether it is feasible to use immersive VR technology as therapy for older adults who have reduced sensory, mobility and/or impaired cognition. This includes evaluation of tolerability, comfort, and ease of use of the HMD, and of the potential for immersive VR to provide enjoyment/relaxation and reduce anxiety and depressive symptoms.Methods: Sixty-six older adults (mean age 80.5, SD = 10.5) with varying cognitive abilities (normal = 28, mild impairment = 17, moderate impairment = 12, severe impairment = 3, unknown cognitive score = 6), and/or physical impairments, entered a multi-site non-randomized interventional study in Toronto, Canada. Participants experienced 3 to 20 min of 360°-video footage of nature scenes displayed on Samsung GearVR HMD. Data was collected through pre/post-intervention surveys, standardized observations during intervention, and post-intervention semi-structured interviews addressing the VR experience.Results: All participants completed the study with no negative side-effects reported (e.g., No dizziness, disorientation, interference with hearing aids); the average time spent in VR was 8 min and 76% of participants viewed the entire experience at least once. Participants tolerated the HMD very well; most had positive feedback, feeling more relaxed and adventurous; 76% wanted to try VR again. Better image quality and increased narrative video content were suggested to improve the experience.Conclusion: It is feasible and safe to expose older adults with various levels of cognitive and physical impairments to immersive VR within these settings. Further research should evaluate the potential benefits of VR in different settings (e.g., home/community based) and explore better customization/optimization of the VR content and equipment for the targeted populations.
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- 2020
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