Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: complex treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04049006

PI1800943

Details and patient eligibility

About

Fibromyalgia (FM) is a chronic disease characterized by chronic pain, fatigue and loss of function that leads to a significant deterioration in the quality of life. Despite controversies about the most appropriate treatment, studies indicate that a multidisciplinary treatment would be effective. This study aims to analyze the effectiveness and cost-utility of a complex intervention in the quality of life (main variable), the functional impact, the mood and the pain of people with FM treated in the Primary Care Teams (PCTs) of the Catalan Institute of Health (CIH).

Full description

Methods and analysis: Mixed methodology study following the recommendations of the Medical Research Council, with two phases. Phase 1: Randomized pragmatic clinical trial with patients diagnosed with FM and assigned to one of the 11 PCTs of the CIH (Territorial management of "Terras del Ebro"). A total sample of 336 patients is estimated.

The usual clinical practice will be carried out in the control group and the usual practice and the complex treatment, in the intervention group. The complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. Statistical analysis: Assessment of the standardized mean response and of the size of the standardized effect and multivariate logistic regression analysis will be performed. The economic analysis will be based on useful measures. Phase 2: Qualitative socio-constructivist study to identify the improvement aspects of the intervention according to the results obtained and the opinions and experiences of the participants (patients and professionals). The sampling will be theoretical with 2 discussion groups composed of participants in the intervention and 2 discussion groups of professionals from different PCTs.

Enrollment: 302 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (all criteria must be met):

• Have a clinical diagnosis of fibromyalgia
• Have a fixed or mobile telephone
• Voluntarily accept participation in the project

Exclusion Criteria:

• Active psychotic outbreak;
• Intellectual deficiency;
• Severe depression and personality disorder;
• Self and hetero-aggressive behaviors;
• Individual assessment of active consumption of psychoactive substances;
• Incompatibility with the group's schedule.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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302 participants in 2 patient groups

complex-treatment benefiting group

Experimental group

Description:

Participants in the intervention group will receive the complex treatment and the usual clinical practice.

Treatment:

Other: complex treatment

complex-treatment no benefiting group

No Intervention group

Description:

Participants in the control group will receive the care from the usual clinical practice