Search

Aim: To measure the Effectiveness of a Diabetes Education Program for people with T2DM, based on Tailored interventions and the Theory of Planned Behaviour., Design: Cluster randomized controlled clinical trial., Methods: This multicentre study will be carried out at 30 primary healthcare centres, where 436 persons with Type 2 Diabetes Mellitus (T2DM), aged between 18-75 years, will be recruited. The experimental educational program to be applied is modelled using components obtained from a systematic review and prior qualitative analysis. In addition, a taxonomy of nursing practice is used to standardize the program, based on the Theory of Planned Behaviour as a conceptual model. The intervention will be carried out by community nurses, using ADAPP-Ti ® , an application developed with FileMaker Pro v.18. The control group will receive usual care and data will be collected at 6, 12, and 18 months, for both groups. The primary outcome considered will be glycosylated haemoglobin and cardiovascular factors, while the secondary ones will be tobacco consumption, body mass index, barriers to self-care, health-related quality of life, and lifestyle modification. The protocol was approved by the Ethics Committee of the Province of Malaga (Spain) in November 2014., Discussion: The degree of metabolic control in T2DM is not always associated with healthy lifestyles and significant levels of medication are often prescribed to achieve clinical objectives. An intervention focused on needs, based on the best available evidence and a solid conceptual framework, might successfully consolidate appropriate self-care behaviour in this population., Impact: The study will result in the publication of an educational program featuring well-defined interventions and activities that will enable clinicians to tailor health care to the individual's needs and to combat treatment inertia in attending this population., (© 2020 John Wiley & Sons Ltd.)

Aim: To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact ® ) against a silver dressing (Aquacel ® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing., Design: Open randomized controlled trial, with blinded endpoint., Methods: Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, and time to healing), level of pain, adverse effects, and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA-typing technique through polymerase chain reaction to obtain the level of colony-forming units. Measures will be collected at baseline, 4, 8, and 12 weeks., Discussion: Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced., Impact: Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes., (© 2020 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.)

Aims and Objectives: To evaluate the effectiveness of self-care programmes in type 2 diabetes mellitus (T2DM) population in primary health care., Background: The impact of educational interventions on T2DM has been evaluated in various contexts, but there is uncertainty about their impact in that of primary care., Design: Systematic review and meta-analysis., Methods: A search was conducted in PubMed, CINAHL, WOS and Cochrane databases for randomised controlled trials carried out in the period January 2005-December 2017, including studies with at least one face-to-face educational interventions. The quality of the evidence for the primary outcome was evaluated using the GRADE System. A meta-analysis was used to determine the effect achieved although only the results classified as critical or important were taken into consideration. Checklist of Preferred Reporting Items for Systematic Reviews and Meta-analyses has been followed. PROSPERO registration Number: CRD42016038833., Results: In total, 21 papers (20 studies) were analysed, representing a population of 12,018 persons with T2DM. For the primary outcome, HbA 1 c, the overall reduction obtained was -0.29%, decreasing the effect in long-term follow-up. The quality of the evidence was low/very low due to very serious risk of bias, inconsistency and indirectness of results. Better results were obtained for individual randomised trials versus cluster designs and in those programmes in which nurses leaded the interventions. The findings for other cardiovascular risk factors were inconsistent., Conclusions: Educational interventions in primary care addressing T2DM could be effective for metabolic control, but the low quality of the evidence and the lack of measurement of critical results generates uncertainty and highlights the need for high-quality trials., Relevance to Clinical Practice: Most of self-care programmes for T2DM in primary care are focused on metabolic control, while other cardiovascular profile variables with greater impact on mortality or patient-reported outcomes are less intensely addressed., (© 2020 John Wiley & Sons Ltd.)

Aim: To evaluate the relationship between the pressure exerted on the heel of one foot resting directly on a mattress, versus that exerted on the other heel, protected by a pillow beneath the Achilles tendon area and the changes thus produced in perfusion, oxygenation and temperature in the skin of heels of healthy volunteers lying in a supine position., Design: Experimental study in a pre-clinical phase, with healthy volunteer participants and intrapeople control., Methods: The study was carried out from November 2017 - May 2018. A pressure measurement surface was placed between the participant and the constant low-pressure support surface. Doppler laser devices were used to measure local temperature and perfusion. The degree of oxygenation was determined using an infrared beam close to the pressure zone in each heel. Both feet rested immobile on the bed, in a natural position, for 2 hr. To ensure intrapeople control, in every case the left heel was raised slightly, compared with the right., Results: Eighteen participants took part in this study. Analysis of the results obtained showed that capillary blood flow was significantly reduced in the heel subjected to pressure, compared with the other heel, while no significant effects on oxygen saturation or temperature were observed. The variables associated with greater oxygen saturation were capillary blood flow, local temperature and pressure exerted. Fat-free mass, fat mass and duration of exposure to pressure were all significantly associated with reduced oxygen saturation., Conclusions: In healthy participants, when the heel is subjected to constant pressure against a constant low-pressure support surface, there is a significant reduction in blood flow, compared with the heel where pressure is relieved. However, there are no significant differences in temperature or tissue oxygenation., Impact: Significant reductions in vascular flow were observed; however, the oxygenation and temperature of the heel tissues remained unchanged. These findings, corroborated in real patients, would advance our understanding and facilitate decision-making on measures to prevent pressure ulcers, such as repositioning or tissue protection., Trial Registration: The protocol is registered in ClinicalTrials.gov (NCT02736838)., (© 2019 John Wiley & Sons Ltd.)

Aim: The aim of this study was to analyse the change in peripheral oxygenation and microvascular flow in tissues subjected to different pressure regimes in healthy subjects and in hospitalized patients., Background: The presence of pressure ulcers in hospitalized patients is a common complication that has a negative impact on health and often prolongs hospital stay and increases healthcare costs., Design: Experimental non-controlled, non-randomized study in two phases: pre-clinical and clinical., Methods: The pre-clinical phase will be conducted in healthy volunteers and the clinical phase, in patients at risk of impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in areas at risk of pressure ulcers will be evaluated by Doppler laser in subjects lying on a capacitive surface to measure pressure at 10,249 points. Different levels of pressure will be generated by changes in body position and changes in tissue perfusion and oxygenation will be monitored for up to 4 hours, to determine the implications for repositioning interventions in patients at risk. This study was funded in July 2015. The protocol is registered in ClinicalTrials.gov (NCT02736838)., Discussion: Pressure ulcer is a significant and complex health problem in long-term bedridden patients and there is currently no effective treatment or efficient prevention method. The information provided by our study will provide an accurate assessment of different thresholds for the onset of damage to the skin, associated with different body positions and pressure levels., Trial Registration: The protocol is registered in ClinicalTrials.gov (NCT02736838)., (© 2017 John Wiley & Sons Ltd.)

Aims and Objectives: To develop a questionnaire to address barriers and self-care behaviour among persons with type 2 diabetes mellitus., Background: Several instruments are available in the literature to measure barriers to self-care in this population, but many of them present limitations in its psychometric validation process, and lack of theoretical background., Design: Content validation study using multiple qualitative methods., Methods: A systematic review was conducted, and two focus groups with fifteen participants (n = 15) were analysed to identify key topics and categories concerning barriers and self-care behaviour. These categories were used to generate items that were subjected to expert scrutiny, using the Delphi technique. The resulting list of items was tested for readability and comprehension by nine diabetic patients (n = 9), through cognitive interviews. The whole process was conducted in accordance with the Theory of Planned Behaviour., Results: The mean age (standard deviation) of participants in the focus groups and cognitive interviews was 66·05 (8·47) and 63·11 (6·13) years, respectively. 46·7% of the members of the focus groups and 44·4% of those interviewed were female, and the mean duration (standard deviation) of their diabetes was 6·53 (3·17) and 4·89 (3·84) years, respectively. After the qualitative analysis, 27 codes were obtained. Thereafter, items were generated in accordance with the dimensions of this theory: attitudes towards the behaviour (n = 23), social norms (n = 13), perceived behavioural control (n = 17) and behavioural intention (n = 15)., Conclusions: A rigorous process of content validation with multiple methods was implemented to obtain an instrument aimed at addressing barriers and self-care behaviour of patients with type 2 Diabetes Mellitus., Relevance to Clinical Practice: An instrument theoretically rooted and supported on professional and patients' views is available to assess self-care behaviours in patients with type 2 Diabetes Mellitus. The evaluation of its reliability and construct validity will determine the instrument's value and practical application in the clinical context., (© 2014 John Wiley & Sons Ltd.)

Aims: This protocol outlines a review and qualitative study to determine the models and effectiveness of Advanced Practice Nursing developed for the health care of people over 65 years in different settings (hospital care, home care, outpatients' care, and nursing homes) and to identify the ingredients of the interventions developed by Advanced Practice Nursing in the field of geriatric care., Background: Numbers of nurses in advanced roles have increased internationally in conjunction with research to determine their effectiveness. Nevertheless, in older people, evidence of advanced practice roles remains scattered, and there is little synthesis of evidence, and therefore it is not easy to visualize the different practice models, their components, and their impact., Design: Study protocol with two phases: a systematic review and a qualitative study., Methods: First phase: Depending on comparability of studies, meta-analysis will be undertaken. If so, results will be summarized in relative and absolute measures or mean difference, depending on the type of outcome. Sensitivity and heterogeneity analyses will be performed. Second phase: a content analysis will be carried out of the interventions identified in the systematic review, and they will be contrasted with the contents of the Nursing Interventions Classification. Finally, this matching will be submitted to expert consensus using a Delphi technique. Approval from the Ethics Committee was obtained in July 2010 and funding was obtained in March 2011., Conclusion: The identification of components of Advanced Practice Nursing models and evidence of their effectiveness will contribute to designing more grounded nursing services for older people. Additionally, the categorization of Advanced Practice Nursing interventions through Nursing Interventions Classification would permit comparisons to be made between settings or between healthcare systems., (© 2012 Blackwell Publishing Ltd.)