Institut Català de la Salut - Gerència Territorial Catalunya Central
Manresa, Barcelona, 08240, Spain
NCT Number: NCT07661745
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and psychological symptoms that significantly affect quality of life. This quasi-experimental study aims to evaluate the effectiveness of the FIBROCatCentral interdisciplinary program in improving health-related quality of life among adults with fibromyalgia receiving care in Primary Care centers in Central Catalonia, Spain.
Participants in the intervention group will attend a structured multidisciplinary program consisting of 24 sessions delivered by healthcare professionals from different disciplines, including nursing, medicine, physiotherapy, nutrition, mental health, social work, and pharmacy. Outcomes will be assessed at baseline and at 3, 6, and 12 months. The primary outcome is health-related quality of life measured using the EuroQol-5D questionnaire. Secondary outcomes include fibromyalgia impact, depressive symptoms, treatment adherence, participant satisfaction, and changes in pharmacological treatment.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Manresa, Barcelona, 08240, Spain
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive symptoms, and psychological distress. The condition has a substantial impact on quality of life and represents a significant burden for healthcare systems due to frequent healthcare utilization and long-term management needs.
Current evidence suggests that isolated pharmacological approaches provide limited benefits. Consequently, multidisciplinary and multicomponent non-pharmacological interventions incorporating physical activity, health education, psychological support, and self-management strategies have emerged as promising approaches for improving patient outcomes.
The FIBROCatCentral study is a quasi-experimental pre-post intervention study designed to evaluate the effectiveness of an optimized interdisciplinary program for people with fibromyalgia in Primary Care settings in Central Catalonia. The study will be conducted in Primary Care centers belonging to the Catalonia Central Health Region of the Catalan Health Institute (ICS).
Eligible participants will be adults aged 18 to 85 years with a diagnosis of fibromyalgia assigned to participating Primary Care centers. Participants choosing to participate in the intervention will be allocated to the intervention group, while those who decline participation in the program but agree to study participation will form the control group and continue receiving usual care.
The intervention consists of 24 one-hour sessions delivered by an interdisciplinary team including nurses, physicians, physiotherapists, emotional well-being professionals, nutritionists, social workers, and pharmacists. The program combines educational and practical activities aimed at improving symptom self-management, physical functioning, emotional well-being, and overall quality of life.
Data will be collected at baseline and at 3, 6, and 12 months using validated questionnaires. The primary outcome will be health-related quality of life assessed with the EuroQol-5D (EQ-5D). Secondary outcomes will include fibromyalgia impact measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R), depressive symptoms measured with the Patient Health Questionnaire-9 (PHQ-9), treatment adherence, participant satisfaction, and changes in pharmacological treatment.
The study hypothesis is that participation in the FIBROCatCentral interdisciplinary program will significantly improve quality of life and fibromyalgia-related symptoms compared with usual care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 24-session interdisciplinary program for people with fibromyalgia delivered by primary care healthcare professionals, including nurses, physicians, physiotherapists, emotional well-being professionals, nutritionists, social workers, and pharmacists. The intervention combines educational and practical activities aimed at improving symptom self-management, quality of life, and overall well-being.
Time frame: Baseline, 3 months, 6 months, and 12 months
Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R).
Time frame: Baseline, 3 months, 6 months, and 12 months
Health-related quality of life assessed using the EuroQol-5D (EQ-5D) questionnaire.
Time frame: Baseline, 3 months, 6 months, and 12 months
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Other
Evaluation of an Optimized Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia: A Quasi-Experimental Study
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