Clinical trial NCT00550966: Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
Official title: Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Quality of life
Primary Care
Non-pharmacological treatment
Cost / Cost-efficacy
Lead sponsor: Institut Catala de Salut
Sponsor class: OTHER_GOV
Collaborators: name: Agència d'Avaluació de Tecnologia i Recerca Mèdiques
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
First posted: 2007-10-30
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Quality of life is measured with the FIQ and the EuroQol-5D.
timeFrame: 1, 2, 6 and 12 months later
Secondary outcomes:
measure: The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI)
timeFrame: 1, 2, 6 and 12 months later
Other outcomes:
Locations:
city: Gava
country: Spain
facility: ABS Bartomeu Fabres Anglada. Institut Català de Salut.
state: Barcelona
Study officials:
affiliation: Institut Català de Salut (ICS)
name: Rita Fernández-Vergel, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Català de Salut (ICS)
name: María Teresa Peñarrubia, Doctor
role: STUDY_DIRECTOR
affiliation: ICS
name: Elena Blanco, Doctor
role: STUDY_CHAIR
affiliation: ICS
name: Mónica Jiménez, Doctor
role: STUDY_CHAIR
affiliation: Fundació Jordi Gol i Gurina. ICS
name: Adrián Montesano, psychology
role: STUDY_DIRECTOR
affiliation: Sant Joan de Déu-Serveis de Salut Mental
name: Antonio Serrano, psychiatrist
role: STUDY_DIRECTOR
affiliation: Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)
name: Juan Vicente Luciano, psychology
role: STUDY_CHAIR
affiliation: ICS
name: Mª del Camino Verduras, Doctor
role: STUDY_CHAIR
affiliation: ICS
name: José Miguel Ruíz, Reumatology
role: STUDY_CHAIR
References:
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.
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.