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Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] (FIBRO-Qol)

Primary Purpose

Fibromyalgia

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Psychoeducative program in fibromyalgic patients

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Arm Label

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI)

Full Information

NCT ID

NCT00550966

First Posted

October 29, 2007

Last Updated

October 29, 2007

Sponsor

Institut Catala de Salut

Collaborators

Agència d'Avaluació de Tecnologia i Recerca Mèdiques, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

1. Study Identification

Unique Protocol Identification Number

NCT00550966

Brief Title

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

Acronym

FIBRO-Qol

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Institut Catala de Salut

Collaborators

Agència d'Avaluació de Tecnologia i Recerca Mèdiques, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Quality of life, Primary Care, Non-pharmacological treatment, Cost / Cost-efficacy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Enrollment

109 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Psychoeducative program in fibromyalgic patients

Other Intervention Name(s)

Fibromyalgia, Psychoeducative program

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

1, 2, 6 and 12 months later

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: