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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Agencia d'Avaluació, Tecnologia i recerca mèdica (AATRM)
Jordi Gol i Gurina Foundation
Information provided by:
Institut Catala de Salut
ClinicalTrials.gov Identifier:
NCT00550966
First received: October 29, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Fibromyalgia
Behavioral: Psychoeducative program in fibromyalgic patients

Study Type: Interventional
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]

Resource links provided by NLM:


Further study details as provided by Institut Catala de Salut:

Primary Outcome Measures:
  • Quality of life is measured with the FIQ and the EuroQol-5D. [ Time Frame: 1, 2, 6 and 12 months later ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 109
Study Start Date: September 2007
Estimated Study Completion Date: February 2010
Arms Assigned Interventions
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.
Other Names:
  • Fibromyalgia
  • Psychoeducative program

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550966

Locations
Spain
ABS Bartomeu Fabres Anglada. Institut Català de Salut.
Gava, Barcelona, Spain, 08850
Sponsors and Collaborators
Institut Catala de Salut
Agencia d'Avaluació, Tecnologia i recerca mèdica (AATRM)
Jordi Gol i Gurina Foundation
Investigators
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
  More Information

No publications provided by Institut Catala de Salut

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00550966     History of Changes
Other Study ID Numbers: 077/25/2006
Study First Received: October 29, 2007
Last Updated: October 29, 2007
Health Authority: Spain: Ethics Committee

Keywords provided by Institut Catala de Salut:
Fibromyalgia
Quality of life
Primary Care
Non-pharmacological treatment
Cost / Cost-efficacy

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014