Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care : a mixed methods study protocol
| Autor: | Caballol Angelats, Rosa, Queiroga Gonçalves, Alessandra, Aguilar Martín, Carina, Sancho Sol, Maria Cinta, González Serra, Gemma, Casajuana Closas, Marc, Carrasco-Querol, Noèlia, Fernández-Sáez, José, Dalmau Llorca, M. Rosa, Abellana, Rosa, Berenguera, Anna, Universitat Autònoma de Barcelona |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Research design Fibromyalgia Cost-Benefit Analysis medicine.medical_treatment law.invention Group psychotherapy 0302 clinical medicine Quality of life Randomized controlled trial law Study Protocol Clinical Trial Health care Medicine 030212 general & internal medicine Randomized Controlled Trials as Topic Primary health care implementation science General Medicine Combined Modality Therapy Exercise Therapy Outcome and Process Assessment Health Care Clinical research ethics Research Design 030220 oncology & carcinogenesis Chronically ill Implementation science Female Health education fibromyalgia Erratum Thematic analysis pragmatic clinical trials Cost utility analysis Research Article Adult medicine.medical_specialty Therapeutics 03 medical and health sciences Patient Education as Topic Qualitative research Humans Cognitive Behavioral Therapy Fibromiàlgia business.industry Health Plan Implementation Patient Acceptance of Health Care Malalts crònics Terapèutica Pragmatic clinical trials primary health care quality of life Physical therapy Feasibility Studies Patient Compliance cost utility analysis business qualitative research |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona Medicine Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona |
| Popis: | Introduction: Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS). Methods and analysis: A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l’Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. Analysis: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out. Ethics and dissemination: This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals. Trial registration: Clinical-Trials.gov: NCT04049006. |
| Databáze: | OpenAIRE |
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