ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 282 for:    quality | "Fibromyalgia"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00550966
Recruitment Status : Unknown
Verified September 2007 by Institut Catala de Salut.
Recruitment status was:  Enrolling by invitation
First Posted : October 30, 2007
Last Update Posted : October 30, 2007
Sponsor:
Collaborators:
Agència d'Avaluació de Tecnologia i Recerca Mèdiques
Jordi Gol i Gurina Foundation
Information provided by:
Institut Catala de Salut

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Psychoeducative program in fibromyalgic patients Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
Study Start Date : September 2007
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550966


Locations
Spain
ABS Bartomeu Fabres Anglada. Institut Català de Salut.
Gava, Barcelona, Spain, 08850
Sponsors and Collaborators
Institut Catala de Salut
Agència d'Avaluació de Tecnologia i Recerca Mèdiques
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

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
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: October 30, 2007
Last Verified: September 2007

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