Status:
COMPLETED
Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients
Lead Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborating Sponsors:
Institut Català de la Salut
Instituto de Salud Carlos III
Conditions:
Fibromyalgia
Eligibility:
All Genders
Phase:
NA
Brief Summary
Fibromyalgia (FM) is a chronic disease characterized by chronic pain, fatigue and loss of function that leads to a significant deterioration in the quality of life. Despite controversies about the mos...
Detailed Description
Methods and analysis: Mixed methodology study following the recommendations of the Medical Research Council, with two phases. Phase 1: Randomized pragmatic clinical trial with patients diagnosed with ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all criteria must be met):
- Have a clinical diagnosis of fibromyalgia
- Have a fixed or mobile telephone
- Voluntarily accept participation in the project
- Exclusion Criteria:
- Active psychotic outbreak;
- Intellectual deficiency;
- Severe depression and personality disorder;
- Self and hetero-aggressive behaviors;
- Individual assessment of active consumption of psychoactive substances;
- Incompatibility with the group's schedule.
Exclusion
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT04049006
Start Date
April 1 2019
End Date
March 31 2021
Last Update
September 7 2023
Active Locations (1)
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1
Institut Català de la Salut
Tortosa, Tarragona, Spain, 43500