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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
Sponsored by
Institut Catala de Salut
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1

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

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
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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
No

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
1
Arm Type
Active Comparator
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.
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
No
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:
First Name & Middle Initial & Last Name & Degree
Rita Fernández-Vergel, Doctor
Organizational Affiliation
Institut Català de Salut (ICS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María Teresa Peñarrubia, Doctor
Organizational Affiliation
Institut Català de Salut (ICS)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elena Blanco, Doctor
Organizational Affiliation
ICS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mónica Jiménez, Doctor
Organizational Affiliation
ICS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adrián Montesano, psychology
Organizational Affiliation
Fundació Jordi Gol i Gurina. ICS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antonio Serrano, psychiatrist
Organizational Affiliation
Sant Joan de Déu-Serveis de Salut Mental
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juan Vicente Luciano, psychology
Organizational Affiliation
Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mª del Camino Verduras, Doctor
Organizational Affiliation
ICS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José Miguel Ruíz, Reumatology
Organizational Affiliation
ICS
Official's Role
Study Chair
Facility Information:
Facility Name
ABS Bartomeu Fabres Anglada. Institut Català de Salut.
City
Gava
State/Province
Barcelona
ZIP/Postal Code
08850
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23328339
Citation
Luciano JV, Sabes-Figuera R, Cardenosa E, T Penarrubia-Maria M, Fernandez-Vergel R, Garcia-Campayo J, Knapp M, Serrano-Blanco A. Cost-utility of a psychoeducational intervention in fibromyalgia patients compared with usual care: an economic evaluation alongside a 12-month randomized controlled trial. Clin J Pain. 2013 Aug;29(8):702-11. doi: 10.1097/AJP.0b013e318270f99a.
Results Reference
derived
PubMed Identifier
21317775
Citation
Luciano JV, Martinez N, Penarrubia-Maria MT, Fernandez-Vergel R, Garcia-Campayo J, Verduras C, Blanco ME, Jimenez M, Ruiz JM, Lopez del Hoyo Y, Serrano-Blanco A; FibroQoL Study Group. Effectiveness of a psychoeducational treatment program implemented in general practice for fibromyalgia patients: a randomized controlled trial. Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b013e31820b131c.
Results Reference
derived

Learn more about this trial

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

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