Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] (FIBRO-Qol)
This research project pretends to demonstrate that a psychoeducative program implemented in the context of PC can produce a significant increase in the quality of life of patients with FM, as well as a decrease in the use of sanitary and social services, compared to usual care.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]|
- Quality of life is measured with the FIQ and the EuroQol-5D. [ Time Frame: 1, 2, 6 and 12 months later ]
- The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI) [ Time Frame: 1, 2, 6 and 12 months later ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||February 2010|
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.
Behavioral: Psychoeducative program in fibromyalgic patients
Multi-component program including information about the illness, counselling about physical exercise and training in autogenic relaxation. The intervention consists on nine 2 hour sessions delivered during a two month period. The pharmacological treatment prescribed by the physician is maintained in both groups.
Most fibromyalgic patients are attended at primary care (PC). However, the effectiveness of the treatments prescribed by general practitioners is usually scarce. The main objective of the present research is to assess the efficacy of a structured psychoeducative intervention, combined with relaxation, developed to improve the quality of life of patients suffering fibromyalgia (FM). The second objective is to assess the cost-effectiveness of this multimodal intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550966
|ABS Bartomeu Fabres Anglada. Institut Català de Salut.|
|Gava, Barcelona, Spain, 08850|
|Principal Investigator:||Rita Fernández-Vergel, Doctor||Institut Català de Salut (ICS)|
|Study Director:||María Teresa Peñarrubia, Doctor||Institut Català de Salut (ICS)|
|Study Chair:||Elena Blanco, Doctor||ICS|
|Study Chair:||Mónica Jiménez, Doctor||ICS|
|Study Director:||Adrián Montesano, psychology||Fundació Jordi Gol i Gurina. ICS|
|Study Director:||Antonio Serrano, psychiatrist||Sant Joan de Déu-Serveis de Salut Mental|
|Study Chair:||Juan Vicente Luciano, psychology||Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)|
|Study Chair:||Mª del Camino Verduras, Doctor||ICS|
|Study Chair:||José Miguel Ruíz, Reumatology||ICS|