Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]

Fibromyalgia Clinical Trial

— FIBRO-Qol  

Official title:

Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00550966
• Other study ID #: 077/25/2006
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 29, 2007
• Last updated: October 29, 2007
• Start date: September 2007
• Est. completion date: February 2010

Study information

• Verified date: September 2007
• Source: Institut Catala de Salut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 109
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Spain	ABS Bartomeu Fabres Anglada. Institut Català de Salut.	Gava	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Institut Catala de Salut	Agència d'Avaluació de Tecnologia i Recerca Mèdiques, Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life is measured with the FIQ and the EuroQol-5D.		1, 2, 6 and 12 months later
Secondary	The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI)		1, 2, 6 and 12 months later