13 results on '"Adherence to pharmacotherapy"'
Search Results
2. Optimisation of MTX treatment in rheumatoid arthritis
- Subjects
methotrexaat ,Pharmacology ,Methotrexate ,Reumatoïde artritis ,farmacologie ,therapietrouw ,Rheumatoid Arthritis ,Adherence to pharmacotherapy - Abstract
This thesis focused on steps towards Therapeutic Drug Monitoring (TDM) for effective MTX treatment and methods to measure(non)adherence towards MTX and biological DMARDs. We studied pharmacokinetics and –dynamics of red blood cell (RBC)-MTX-PGs, ways to personalise MTX treatment, including a comparison of different cell types in which MTX was measured, and a proposed PKPD model. As a bridge, drug levels of MTX were compared with electronic monitoring of drug intake. Furthermore, adherence to (biological) DMARDs and ways to measure and improve this were revealed. For more information, please see the full summary.
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- 2023
3. Optimisation of MTX treatment in rheumatoid arthritis:: Current reflections on a personalised approach
- Author
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Hebing, Renske Carolina Frieda and Hebing, Renske Carolina Frieda
- Abstract
This thesis focused on steps towards Therapeutic Drug Monitoring (TDM) for effective MTX treatment and methods to measure(non)adherence towards MTX and biological DMARDs. We studied pharmacokinetics and –dynamics of red blood cell (RBC)-MTX-PGs, ways to personalise MTX treatment, including a comparison of different cell types in which MTX was measured, and a proposed PKPD model. As a bridge, drug levels of MTX were compared with electronic monitoring of drug intake. Furthermore, adherence to (biological) DMARDs and ways to measure and improve this were revealed. For more information, please see the full summary.
- Published
- 2023
- Full Text
- View/download PDF
4. La importancia del farmacéutico en la adherencia a la Terapia Antirretroviral (TAR) en la gestión del cuidado en VIH/SIDA
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Silva, Alessandro Tavares da, Silva, Camila Tavares da, Cardoso, Daniel Siqueira, Oliveira Júnior, José Reinaldo Ferreira de, Barros, Landerson Guimarães, Alho, Rosane da Costa, Gama, Regiana Almeida da, and Rodrigues Junior , Omero Martins
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Cuidado farmacéutico ,ART ,Adherencia a la farmacoterapia ,Antirretrovirais ,Antiretrovirals ,ARTE ,SIDA/VIH ,AIDS/HIV ,antirretrovirales ,Pharmaceuticalassistance ,Assistência farmacêutica ,TARV ,Adherence to pharmacotherapy ,Adesão à farmacoterapia - Abstract
HIV emerged in the early 1980s and has slightly become a public health problem of worldwide magnitude. The pharmacist's role with clinical teams in hospitals that care for a patient with the HIV virus has led to a growing increase in patient adherence, as it is known that the pharmacist is the essential professional to accompany the patient throughout his/her trajectory. of drug use. This article aims to: Present the role of the pharmacist in adherence to Antiretroviral Therapy, in the management of care in HIV/AIDS. To this end, a bibliographic study of the literature review type, of a qualitative exploratory nature, was carried out in the following databases: SCIELO, MEDLINE, PUBMED and LILACS, in which only studies published between 2016-2021, in Portuguese, English, were selected. . It was possible to perceive that great advances have been achieved in Brazil in terms of legislation and universal and free access to antiretroviral therapy (ART) since the discovery of AIDS, however, therapeutic success requires high levels of adherence to treatment, which has a greater tendency when the multiprofessional team has a pharmacist who works clinically with the patient. Thus, more awareness is proposed about the need for professionals such as pharmacists who are on the front line with their pharmacotherapeutic knowledge in the treatment of HIV/AIDS. El VIH surgió a principios de la década de 1980 y se ha convertido levemente en un problema de salud pública de magnitud mundial. El papel del farmacéutico con los equipos clínicos en los hospitales que atienden a un paciente con el virus del VIH ha propiciado un aumento creciente de la adherencia del paciente, ya que se sabe que el farmacéutico es el profesional imprescindible para acompañar al paciente a lo largo de su trayectoria de fármaco. usar. Este artículo tiene como objetivo: Presentar el papel del farmacéutico en la adherencia a la Terapia Antirretroviral, en la gestión del cuidado en VIH/SIDA. Para ello, se realizó un estudio bibliográfico del tipo revisión bibliográfica, de carácter exploratorio cualitativo, en las siguientes bases de datos: SCIELO, MEDLINE, PUBMED y LILACS, en el que solo se incluyeron estudios publicados entre 2016-2021, en portugués, inglés, fueron seleccionados. Fue posible notar que se han logrado grandes avances en Brasil en términos de legislación y acceso universal y gratuito a la terapia antirretroviral (TAR) desde el descubrimiento del SIDA, sin embargo, el éxito terapéutico requiere altos niveles de adherencia al tratamiento, lo que tiene una mayor tendencia cuando el equipo multiprofesional cuenta con un farmacéutico que trabaja clínicamente con el paciente. Así, se propone una mayor concienciación sobre la necesidad de profesionales como los farmacéuticos que estén en primera línea con sus conocimientos farmacoterapéuticos en el tratamiento del VIH/SIDA. O HIV surgiu no começo da década de 1980 e tornou-se ligeiramente um problema de saúde pública de magnitudes mundiais. A atuação do farmacêutico com as equipes clínicas em hospitais que cuidam de paciente portador do vírus do HIV tem ocasionado um aumento crescente da adesão pelo paciente, pois se sabe que o farmacêutico é o profissional imprescindível para acompanhar o paciente no decorrer de toda a sua trajetória de uso do medicamento. O presente artigo tem como objetivo: Apresentar a atuação do farmacêutico na adesão a Terapia Antirretroviral, na gestão do cuidado em HIV/AIDS. Para tal, realizou-se um estudo bibliográfico do tipo revisão de literatura, de caráter exploratório qualitativo, nas bases de dados: SCIELO, MEDLINE, PUBMED e LILACS, em que se selecionou apenas estudos publicados entre 2016-2021, na língua portuguesa, inglesa. Foi possível perceber que grandes avanços foram alcançados no Brasil em termos de legislação e acesso universal e gratuito à terapia antirretroviral (TARV) desde a descoberta da AIDS, contudo, o sucesso terapêutico exige níveis elevados de adesão ao tratamento, que possui uma tendência maior quando a equipe multiprofissional conta com um farmacêutico que atua de forma clínica junto ao paciente. Assim, propõe-se mais conscientização sobre a necessidade de profissionais como o farmacêutico que está em linha de frente com seus conhecimentos farmacoterápicos no tratamento do HIV/AIDS.
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- 2022
5. Influence of the Cognitive and Emotional Status of Patients with Chronic Pain on Treatment Success (Reduction in Pain Intensity and Adherence to Pharmacotherapy): A Prospective Study
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Dijana Hnatešen, Ivan Radoš, Iva Dimitrijević, Dino Budrovac, Ivan Omrčen, Roman Pavić, Ivana Gusar, Maja Čebohin, and Krešimir Šolić
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Cognition ,Health, Toxicology and Mutagenesis ,Public Health, Environmental and Occupational Health ,emotional status ,cognitive status ,chronic pain ,adherence to pharmacotherapy ,pain reduction ,Humans ,Prospective Studies ,Chronic Pain ,Anxiety ,Pain Measurement - Abstract
This prospective study aimed to determine the cognitive and emotional status among patients with chronic pain and to examine the potential influence on the treatment success, measured by the reduction in pain intensity and adherence to pharmacotherapy. A total of seventy patients were followed for two months. The results of the comparison between patients who did and did not follow the physician’s instructions regarding adherence to pharmacotherapy showed a significant difference in cognitive status and a reduction in pain intensity. Patients who followed the physician’s instructions on taking analgesics had significantly higher scores on the Montreal Cognitive Assessment (MoCA) of cognitive status and a substantially higher reduction in pain intensity. Scores on the MoCA test provide statistically significant indications regarding patients’ decision to follow instructions regarding adherence to pharmacotherapy. Scores on the MoCA test, anxiety, age, and pain intensity (measured with a numeric rating scale—NRS) on admission were identified as potential predictors for the reduction in pain intensity. The linear regression model was statistically significant (χ2 = 40.0, p < 0.001), explained between 43.5% and 61.1% of variance regarding the reduction in pain intensity. The findings of this study show that cognitive status, measured with MoCA, and emotional status, measured with the Depression, Anxiety, and Stress Scale (DASS-21), significantly influence the reduction in pain intensity and adherence to pharmacotherapy. The results suggest that cognitive and emotional status may be potential predictors of treatment success. This finding points to the importance of a biopsychosocial approach in the treatment of chronic pain, where an important emphasis can be placed on the psychosocial determinants of pain.
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- 2022
6. Adherence to pharmacotherapy improves school performance in children with rhinitis and asthma
- Author
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Jorge Mario Sánchez, Andrés Sánchez, and Ricardo Cardona
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asthma ,rhinitis ,adherence to pharmacotherapy ,school performance ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Background: Adherence to pharmacotherapy reduces clinical symptoms of asthma and rhinitis, however, little is known of its impact on school performance in children. Objective: To evaluate the impact of pharmacotherapy on the control of rhinitis symptoms in a school population. Methods: A cross-sectional study, carried out in eight schools of two cities. All participants were given a questionnaire assessing parameters related to the severity of rhinitis and asthma, pharmacotherapy, adherence, school absenteeism and the scores obtained during the last academic year. Results: 1109 students agreed to participate. We divided the students into two groups: symptomatic group (36 %) and asymptomatic group (63 %). The symptomatic group had a higher frequency of school absenteeism (1 vs. 3.1 days/year/patient, p
- Published
- 2018
7. Adherencia a la farmacoterapia en pacientes hipertensos ambulatorios que asisten al programa de control de hipertensión arterial en el Hospital Jorge Cristo Sahium, Norte de Santander (Colombia.
- Author
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RAMÍREZ PINZÓN, CARLOS JULIO
- Abstract
Introduction: Hypertension is a chronic disease that impairs vital organs and alters the quality of life of patients, who must remain in drug treatment with hypotensive and vasodilator medicine to control their blood pressure. Objective: To determine the degree of adherence of chronic hypertensive patients to ongoing drug therapy, as well as the relationship between their habits and attitudes with this chronic disease. Methodology: Through a quantitative, descriptive and cross-sectional study based on the Morisky-Green test, a multivariate analysis of outpatients attending the hypertension control program in the Jorge Cristo Sahium Hospital, Villa del Rosario, Norte de Santander, Colombia was performed. Results: The total amount of people included in the program is of 563 patients, among which a representative sample of 154 was chosen; 87.34 % were women and 12.66% were men; the average age was of 66.295 ± 11.393 years, and 62 (39.74%) patients completed the treatment. Conclusions: The most commonly used drugs for high blood pressure were those from the antagonist pharmacological group of angiotensin II receptors (ARA II) and the angiotensin-convertingenzyme inhibitors (ACE inhibitors), together with diuretics and antiplatelet agents. Patients often discontinue their medications for certain periods of time, which causes their nonadherence to pharmacotherapy. [ABSTRACT FROM AUTHOR]
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- 2014
- Full Text
- View/download PDF
8. Influence of the Cognitive and Emotional Status of Patients with Chronic Pain on Treatment Success (Reduction in Pain Intensity and Adherence to Pharmacotherapy): A Prospective Study.
- Author
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Hnatešen D, Radoš I, Dimitrijević I, Budrovac D, Omrčen I, Pavić R, Gusar I, Čebohin M, and Šolić K
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- Humans, Prospective Studies, Pain Measurement, Anxiety drug therapy, Anxiety psychology, Cognition, Chronic Pain drug therapy
- Abstract
This prospective study aimed to determine the cognitive and emotional status among patients with chronic pain and to examine the potential influence on the treatment success, measured by the reduction in pain intensity and adherence to pharmacotherapy. A total of seventy patients were followed for two months. The results of the comparison between patients who did and did not follow the physician’s instructions regarding adherence to pharmacotherapy showed a significant difference in cognitive status and a reduction in pain intensity. Patients who followed the physician’s instructions on taking analgesics had significantly higher scores on the Montreal Cognitive Assessment (MoCA) of cognitive status and a substantially higher reduction in pain intensity. Scores on the MoCA test provide statistically significant indications regarding patients’ decision to follow instructions regarding adherence to pharmacotherapy. Scores on the MoCA test, anxiety, age, and pain intensity (measured with a numeric rating scale—NRS) on admission were identified as potential predictors for the reduction in pain intensity. The linear regression model was statistically significant (χ2 = 40.0, p < 0.001), explained between 43.5% and 61.1% of variance regarding the reduction in pain intensity. The findings of this study show that cognitive status, measured with MoCA, and emotional status, measured with the Depression, Anxiety, and Stress Scale (DASS-21), significantly influence the reduction in pain intensity and adherence to pharmacotherapy. The results suggest that cognitive and emotional status may be potential predictors of treatment success. This finding points to the importance of a biopsychosocial approach in the treatment of chronic pain, where an important emphasis can be placed on the psychosocial determinants of pain.
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- 2022
- Full Text
- View/download PDF
9. Adherence to pharmacotherapy improves school performance in children with rhinitis and asthma
- Author
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Andrés Sánchez, J. Sanchez, and Ricardo Cardona
- Subjects
Male ,Allergy ,0302 clinical medicine ,Anti-Allergic Agents ,Absenteeism ,Immunology and Allergy ,Anti-Asthmatic Agents ,030212 general & internal medicine ,Child ,Alergia e Inmunología ,Rhinitis ,General Medicine ,School performance ,Female ,medicine.symptom ,lcsh:Immunologic diseases. Allergy ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Adolescent ,education ,Immunology ,Asymptomatic ,Renitis ,Medication Adherence ,school performance ,03 medical and health sciences ,rhinitis ,Pharmacotherapy ,Allergy and Immunology ,medicine ,Humans ,Learning ,Students ,Asma ,Asthma ,Aprendizaje ,business.industry ,asthma ,School absenteeism ,medicine.disease ,Cross-Sectional Studies ,030228 respiratory system ,Family medicine ,Child population ,Absentismo ,adherence to pharmacotherapy ,lcsh:RC581-607 ,business - Abstract
Background Adherence to pharmacotherapy reduces symptoms of asthma and rhinitis, however, little is known of its impact on school performance. Objective To evaluate the impact of pharmacotherapy in absenteeism and school performance in a child population. Methods A cross-sectional study, carried out in eight schools. All participants and their parents were given a questionnaire assessing parameters related to respiratory diseases and pharmacotherapy. Data on school performance was obtained from the academic history of each child who participated in the study. Adherence to pharmacotherapy was classified as a correct use of therapy for more than five days per week. Results 1109 children agreed to participate. Students were divided into two groups: symptomatic (36%) and asymptomatic (63%). The symptomatic group had a higher frequency of school absenteeism (1 vs. 3.1days/year/patient p
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- 2018
10. Adesão à farmacoterapia em pacientes com hipertensão arterial : overview de revisões sistemáticas
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Santos, Aline de Jesus and Silva, Francilene Amaral da
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Arterial hypertension ,Terapêutica ,Revisão sistemática ,Adesão ,Overview ,Medicamentos ,Systematic review ,FARMACOLOGIA [CIENCIAS BIOLOGICAS] ,Farmácia ,Hipertensão arterial ,Adherence to pharmacotherapy ,Hipertensão ,Adesão à farmacoterapia - Abstract
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES INTRODUCTION: Increasing morbidity and mortality rates caused by arterial hypertension and health care expenditures have been a serious public health problem. Adherence to treatment is critical to overcome this problem. There are a large number of studies on the subject, but rarely all relevant points and potential interventions for the situation are addressed in a single systematic review, leaving a gap for decisions in clinical practice. So this justifies the importance of elaborating an overview able to compile information from relevant reviews on adherence to pharmacotherapy in hypertensive patients. METHODOLOGY: The research design is in accordance with the definitions reported in the PRISMA statement. The sample is composed of systematic reviews that address the adherence of hypertensive patients to the treatment. The search for the studies was carried out in the databases COCHRANE, LILACS, PubMed / Medline, SCOPUS, Web of Science and the evaluation of the methodological quality of the studies was evaluated through the AMSTAR instrument. RESULTS: A total of 1,094 records were identified on the subject in the respective databases. At the end of the selection process, 17 systematic reviews fulfilled the inclusion criteria in this study. The quality of the systematic reviews ranged from low (3 points) to high (10 points), according to the AMSTAR quality assessment instrument. The number of studies included in the systematic reviews ranged from 6 to 101, with an average of 36 studies per systematic review, providing a total of 612 primary studies included in the overview. The most used methodologies to measure adherence were self-report, pill count and electronic medication monitoring (MEMS). Interventions were more effective in women, elderly and moderate in patients with high socioeconomic status. And increased adherence to antihypertensive drugs and blood pressure control were more effective in multifactorial or complex interventions, including combinations of different strategies, which are performed over several days. CONCLUSIONS: Several sources of heterogeneity were identified in the systematic reviews and meta-analysis on the adherence of hypertensive patients to treatment, thus demonstrating that there is a need to create specific quality criteria for studies that evaluated adherence. In addition, no method described in the literature can be considered the gold standard for assessing adherence to treatment in hypertensive patients and there is no single intervention that can be considered as the best option to improve adherence to the treatment of hypertensive patients. Due to the complexity of the adhesion process, it is necessary for the health professional to know the individual characteristics of the patients and to formulate specific interventions according to the needs of each individual. INTRODUÇÃO: As crescentes taxas de morbimortalidade ocasionadas pela hipertensão arterial e os gastos gerados em saúde têm constituído um grave problema de saúde pública. A adesão ao tratamento é fundamental para contornar este problema. Há uma grande quantidade de estudos acerca do tema, mas raramente todos os pontos relevantes e as potenciais intervenções para a situação são abordadas numa única revisão sistemática, deixando uma lacuna para as decisões na prática clínica, o que justifica a importância da elaboração de uma overview capaz de compilar as informações de revisões relevantes sobre adesão a farmacoterapia em pacientes hipertensos. METODOLOGIA: O delineamento da pesquisa está de acordo com a declaração PRISMA. A amostra é composta por revisões sistemáticas que abordam a adesão de pacientes hipertensos ao tratamento. A busca dos estudos foi realizada nas bases de dados COCHRANE, LILACS, PubMed/Medline, SCOPUS, Web of Science e a avaliação da qualidade metodológica dos estudos foi avaliada por meio do instrumento AMSTAR. RESULTADOS: Foram identificados inicialmente 1,094 registros sobre o tema nas respectivas bases de dados, sendo que ao final do processo de seleção, 17 revisões sistemáticas preencheram os critérios de inclusão nessa pesquisa. A qualidade das revisões sistemáticas variou de baixa (3 pontos) a alta (10 pontos), de acordo com o instrumento de avaliação de qualidade AMSTAR. O número de estudos incluídos nas revisões sistemáticas variou de 6 a 101, com uma média de 36 estudos por revisão sistemática, fornecendo um total de 612 estudos primários incluídos na overview. As metodologias mais utilizadas para mensurar a adesão foram o autorrelato, a contagem de comprimidos e o monitoramento eletrônico de medicamentos (MEMS). As intervenções foram mais efetivas em mulheres, idosos e moderada em pacientes de alto status socioeconômico. Foram mais eficazes no aumento da adesão aos medicamentos anti-hipertensivos e controle da pressão arterial as intervenções multifatoriais ou complexas, incluindo combinações de diferentes estratégias e que são realizadas ao longo de vários dias. CONCLUSÕES: Foram identificadas várias fontes de heterogeneidades nas revisões sistemáticas e metanálises sobre adesão dos pacientes hipertensos ao tratamento, demonstrando assim a necessidade de criação de critérios de qualidade específicos para estudos que avaliam a adesão. Nenhum método descrito na literatura pode ser considerado o padrão-ouro para avaliação da adesão ao tratamento em pacientes hipertensos e não existe uma única intervenção que possa ser considerada como a melhor opção para melhorar a adesão ao tratamento de hipertensos. Devido a complexidade do processo de adesão é necessário que o profissional de saúde conheça as características individuais dos pacientes e que formule intervenções específicas de acordo com a necessidade de cada indivíduo. São Cristóvão, SE
- Published
- 2017
11. Adherence to pharmacotherapy improves school performance in children with rhinitis and asthma.
- Author
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Sánchez, Jorge Mario, Sánchez, Andrés, and Cardona, Ricardo
- Subjects
- *
DRUG therapy , *ASTHMA , *RHINITIS , *SCHOOL absenteeism , *PHARMACOLOGY - Abstract
Background: Adherence to pharmacotherapy reduces clinical symptoms of asthma and rhinitis, however, little is known of its impact on school performance in children. Objective: To evaluate the impact of pharmacotherapy on the control of rhinitis symptoms in a school population. Methods: A cross-sectional study, carried out in eight schools of two cities. All participants were given a questionnaire assessing parameters related to the severity of rhinitis and asthma, pharmacotherapy, adherence, school absenteeism and the scores obtained during the last academic year. Results: 1109 students agreed to participate. We divided the students into two groups: symptomatic group (36 %) and asymptomatic group (63 %). The symptomatic group had a higher frequency of school absenteeism (1 vs. 3.1 days/year/patient, p < 0.01) and lower academic performance (failed, 20 vs. 33 %, p < 0.01) than the asymptomatic group. After dividing the symptomatic group between adherents and non-adherents to the pharmacological treatment, the group of adherents had a similar school performance than the asymptomatic group. Conclusions: Asthma and rhinitis are associated with poor school performance in children and with an increase in school absenteeism, but adherence to pharmacotherapy can improve clinical control and reduce the negative impact on the school level. [ABSTRACT FROM AUTHOR]
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- 2018
12. Barriers to Adherence to Pharmacotherapy among Patients with Hypertension: A Cross-Sectional Study
- Author
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Najimi, A., firoozeh mostafavi, Sharifirad, G., and Golshiri, P.
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lcsh:R5-920 ,Interpersonal Conflicts ,Depression ,Hypertension ,Coping Strategies ,lcsh:R ,Adherence to Pharmacotherapy ,lcsh:Medicine ,lcsh:Medicine (General) - Abstract
There are multiple barriers in order to cause or improve adherence to medication among the patients with hypertension; and recognize the relevant obstacles is a significant stage in performing effective interventions. Accordingly, the current study seeks to examine personal psychological and environmental obstacles influencing adherence to pharmacotherapy in the patients with hypertension. In the current cross-sectional study, 390 patients with hypertension sponsored by health centers in Isfahan city (Iran) were examined. The sampling in the current research was performed in several stages. The data collection method was demographic factor questionnaire, eightitem Morisky Medication Adherence Scale (MMAS), Beck Depression Inventory, and John Henry Active Coping Scale. The data relevant to the subjects was collected and analyzed in a self-reporting manner. According to results,12 percent of patients had adherence to medication. The patients with low scores of active coping reported the greater level of non-adherence to pharmacotherapy(OR = 0.17 95% CI 0.06-0.65).Furthermore, the patients who had higher level of depression and interpersonal conflicts with family reported higher non-adherence to pharmacotherapy(respectively OR= 1.50 95% CI 1.05-3.46, OR=1.99 95% CI 1.03-3.6). The results suggest that depression, interpersonal conflicts and also application of active coping strategies in the patients with hypertension can play an important part in their adherence to pharmacotherapy.
13. Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): study protocol for a randomized controlled trial
- Author
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Petretto, Dr, Preti, A, Zuddas, C, Veltro, F, Rocchi, Mb, Sisti, D, Martinelli, V, Carta, Mg, Masala, C, Alfa, Rita, Arcidiacono, E, Aguglia, E, Bonanni, E, Borea, M, Consolazione, M, De Giglio, P, DI ROSA, Antonio, Faravelli, C, Fioravanti, G, Fiori Nastro, P, Floris, A, Floris, F, Iannone, C, Iuso, S, La Verde, M, Laffranchini, L, Lecca, Me, Sauro, Cl, Magni, Lr, Margari, F, Marras, M, Marzano, L, Masotti, E, Matta, C, Minutolo, G, Moro, Mf, Mura, G, Nardini, M, Nicchiniello, I, Padalino, F, Papini, Mn, Pastore, A, Petito, A, Pioli, R, Porfiri, Gm, Pullara, A, Sancassiani, F, Seu, Mi, Stallone, V, Vinci, S, and Zappone, L.
- Subjects
Research design ,Health Knowledge, Attitudes, Practice ,Time Factors ,medicine.medical_treatment ,Medicine (miscellaneous) ,Adherence to pharmacotherapy ,Caregiver ,Falloon's method ,Family ,Psychoeducation ,Randomized controlled trial ,Schizophrenia ,law.invention ,Study Protocol ,Clinical Protocols ,Cost of Illness ,Recurrence ,law ,Surveys and Questionnaires ,Pharmacology (medical) ,Chromatography, High Pressure Liquid ,Intention to Treat Analysis ,Treatment Outcome ,Caregivers ,Italy ,Research Design ,Schizophrenic Psychology ,Family Relations ,Drug Monitoring ,Psychosocial ,Antipsychotic Agents ,medicine.medical_specialty ,Blinding ,Medication Adherence ,Pharmacotherapy ,Patient Education as Topic ,schizophrenia ,Psychological adjustment ,caregivers ,medicine ,Humans ,Psychiatry ,Psychiatric Status Rating Scales ,Intention-to-treat analysis ,business.industry ,Falloon’s method ,Supportive psychotherapy ,Physical therapy ,Feasibility Studies ,business - Abstract
Poor adherence to pharmacotherapy negatively affects the course and the outcome of schizophreniaspectrum psychoses, enhancing the risk of relapse. Falloon and coworkers developed a Psychoeducation Program aimed at improving communication and problem-solving abilities in patients and their families. This study set out to evaluate changes in adherence to pharmacotherapy in patients diagnosed with schizophrenia-spectrum psychoses, by comparing one group exposed to the Falloon Psychoeducation Program (FPP) with another group exposed to family supportive therapy with generic information on the disorders. 340 patients diagnosed with schizophrenia and related disorders according to standardized criteria from 10 participating units distributed throughout the Italian National Health System (NHS), will be enrolled with 1:1 allocation by the method of blocks of randomized permutations. Patients will be reassessed at 6, 12 and 18 months after start of treatment (duration: 6 months). The primary objective is to evaluate changes in adherence to pharmacotherapy after psychoeducation. Adherence will be assessed at three-month intervals by measuring blood levels of the primary prescribed drug using high pressure liquid chromatography, and via the Medication Adherence Questionnaire and a modified version of the Adherence Interview. Secondary objectives are changes in the frequency of relapse and readmission, as the main indicator of the course of the disorder. Enrolled patients will be allocated to the FPP (yes/no) randomly, 1:1, in a procedure controlled by the coordinating unit; codes will be masked until the conclusion of the protocol (or the occurrence of a severe negative event). The raters will be blind to treatment allocation and will be tested for blinding after treatment completion. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate the missing data. The study started recruitment in February 2013; the total duration of the study is 27 months. If the psychoeducation program proves effective in improving adherence to pharmacotherapy and in reducing relapse and readmissions, its application could be proposed as a standard adjunctive psychosocial treatment within the Italian NHS. Protocol Registration System of ClinicalTrials.gov NCT01433094 ; registered on 20 August 2011; first patient was randomized on 12 February 2013.
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