Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] (FIBRO-Qol)
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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] |
- Quality of life is measured with the FIQ and the EuroQol-5D. [ Time Frame: 1, 2, 6 and 12 months later ]
- 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:
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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 |
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| Spain | |
| ABS Bartomeu Fabres Anglada. Institut Català de Salut. | |
| Gava, Barcelona, Spain, 08850 | |
| 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 May 22, 2013