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| Name | Class |
|---|---|
| Agència d'Avaluació de Tecnologia i Recerca Mèdiques | OTHER |
| Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducative program in fibromyalgic patients | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life is measured with the FIQ and the EuroQol-5D. | 1, 2, 6 and 12 months later |
| Measure | Description | Time Frame |
|---|---|---|
| The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI) | 1, 2, 6 and 12 months later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Fernández-Vergel, Doctor | Institut Català de Salut (ICS) | Principal Investigator |
| MarÃa Teresa Peñarrubia, Doctor | Institut Català de Salut (ICS) | Study Director |
| Elena Blanco, Doctor | ICS | Study Chair |
| Mónica Jiménez, Doctor | ICS | Study Chair |
| Adrián Montesano, psychology | Fundació Jordi Gol i Gurina. ICS | Study Director |
| Antonio Serrano, psychiatrist | Sant Joan de Déu-Serveis de Salut Mental | Study Director |
| 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 RuÃz, Reumatology | ICS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ABS Bartomeu Fabres Anglada. Institut Català de Salut. | Gavà | Barcelona | 08850 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23328339 | Derived | 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. | |
| 21317775 |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Derived |
| 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. |
| D009422 |
| Nervous System Diseases |