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Clinical Trials/NCT00550966
NCT00550966
Unknown
N/A

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

Institut Catala de Salut1 site in 1 country109 target enrollmentSeptember 2007
ConditionsFibromyalgia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Institut Catala de Salut
Enrollment
109
Locations
1
Primary Endpoint
Quality of life is measured with the FIQ and the EuroQol-5D.
Last Updated
18 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
February 2010
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut Catala de Salut

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.

Outcomes

Primary Outcomes

Quality of life is measured with the FIQ and the EuroQol-5D.

Time Frame: 1, 2, 6 and 12 months later

Secondary Outcomes

  • 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)

Study Sites (1)

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