Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT04049006
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2019-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients
Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Study Overview
Official Title:
Primary Care as a Promoter of the Quality of Life of Fibromyalgia Patients. Effectiveness and Cost-utility of a Complex Intervention Through a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: