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Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia

Evaluation of an Optimized Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia: A Quasi-Experimental Study

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Barcelona
      • Manresa、Barcelona、西班牙、08240
        • Institut Català de la Salut - Gerència Territorial Catalunya Central

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Fibromyalgia Impact
大体时间:Baseline, 3 months, 6 months, and 12 months
Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R).
Baseline, 3 months, 6 months, and 12 months
Health-Related Quality of Life
大体时间:Baseline, 3 months, 6 months, and 12 months
Health-related quality of life assessed using the EuroQol-5D (EQ-5D) questionnaire.
Baseline, 3 months, 6 months, and 12 months
Depressive Symptoms
大体时间:Baseline, 3 months, 6 months, and 12 months
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
Baseline, 3 months, 6 months, and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年11月15日

初级完成 (实际的)

2026年5月21日

研究完成 (实际的)

2026年5月21日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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