Evaluation of an Optimized Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia.
- •Age between 18 and 85 years.
- •Assigned to a participating Primary Care Center in the Central Catalonia region (Bages, Berguedà, Moianès, or Calaf areas).
- •Ability and willingness to provide written informed consent.
排除标准
- •Severe mental illness.
- •Current follow-up in a specialized hospital fibromyalgia unit and previous participation in a therapeutic group program for fibromyalgia.
- •Inability to complete study questionnaires due to language barriers, illiteracy, or other limitations affecting reading or writing.
- •Refusal or inability to provide informed consent.
研究组 & 干预措施
Control
Participants will continue receiving usual care in Primary Care, including routine follow-up visits and pharmacological management of symptoms as determined by their healthcare professionals.
Intervention
Participants will receive the FIBROCatCentral interdisciplinary program consisting 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, quality of life, and overall well-being.
干预措施: FIBROCatCentral Multidisciplinary Intervention Program (Behavioral)
结局指标
主要结局
Fibromyalgia Impact
时间窗: Baseline, 3 months, 6 months, and 12 months
Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R).
Health-Related Quality of Life
时间窗: Baseline, 3 months, 6 months, and 12 months
Health-related quality of life assessed using the EuroQol-5D (EQ-5D) questionnaire.
Depressive Symptoms
时间窗: Baseline, 3 months, 6 months, and 12 months
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
次要结局
未报告次要终点