Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] (FIBRO-Qol)
Fibromyalgia
About this trial
This is an interventional supportive care trial for Fibromyalgia focused on measuring Fibromyalgia, Quality of life, Primary Care, Non-pharmacological treatment, Cost / Cost-efficacy
Eligibility Criteria
Inclusion Criteria:
- Patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the American College of Rheumatology (ACR)
Exclusion Criteria:
- Patients with a diagnosis not based on the ACR criteria
- Those with cognitive impairment or suffering from physical mental/psychiatric limitations
- Severe concurrent rheumatologic illness that impede participation in the study evaluations
- Those who are not expected to live at least 12 months
- Those without schooling.
Sites / Locations
- ABS Bartomeu Fabres Anglada. Institut Català de Salut.
Arms of the Study
Arm 1
Active Comparator
1
Randomized controlled trial with a 12-month follow-up involving two groups, one of which is the intervention group that includes patients receiving a psychoeducative program and the other is the control group formed by patients treated for FM in the usual way. Setting. Three urban PC centers in the province of Barcelona (Spain) Sample. The total sample comprises 218 patients (over 18 years of age) suffering FM, selected from a database (Rheumatology service-Viladecans hospital) of patients with this illness. Only those patients introduced in the database between the years 2005 and 2007 are included in the selection. Selected patients are asked for written informed consent to participate in the study.