CompletedNot Applicable

Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia

Spain100 participantsStarted 2024-11-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fibromyalgia Impact

Timeframe: Baseline, 3 months, 6 months, and 12 months

Health-Related Quality of Life

Timeframe: Baseline, 3 months, 6 months, and 12 months

Depressive Symptoms

Timeframe: Baseline, 3 months, 6 months, and 12 months

Trial details

NCT IDNCT07661745

SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-21

View on ClinicalTrials.gov More Fibromyalgia (FM) trials

Plain-language summary

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.