Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: complex-treatment benefiting group Participants in the intervention group will receive the complex treatment and the usual clinical practice. |
Other: complex treatment
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. The sessions will be conducted in the primary health care by trained professionals.
|
| No Intervention: complex-treatment no benefiting group Participants in the control group will receive the care from the usual clinical practice |
Outcome Measures
Primary Outcome Measures
- Change in life quality [change from life quality at 3, 9 and 15 months after the beginning of the study]
to be evaluated with the health questionnaire (SF-36v2). It will be measured by a scale Likert: 0 (worst) to 100 (best).
- Change in functional impact of fibromyalgia [Change from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study.]
to be evaluated with the Revised Questionnaire on the Impact of Fibromyalgia (FIQR) It will be measured by a scale Likert: 0 (best) to 100 (worst).
- Change in tender points [Change from tender points at 3, 9 and 15 months after the beginning of the study.]
Tender points evaluate the presence of pain in 18 areas of the body and will be measured by a scale Likert: 0 (best) to 18 (worst).
- Change in Visual Analog Scale for pain (VAS) [Change from VAS at 3, 9 and 15 months after the beginning of the study.]
The VAS evaluates the self-perceived intensity of pain by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).
- Change in mood indicator (anxiety) [Change from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study.]
To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).
- Change in mood indicator (depression) [Change from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study.]
To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).
Secondary Outcome Measures
- Sociodemographic characteristics of the patients [baseline (pre intervention period)]
age, sex, level of education, work disability and family coexistence
- Presence/absence of physical manifestations [baseline (pre intervention period)]
Physical manifestations to be evaluated: non-repairing sleep, excessive fatigue, dryness of mucous membranes, Raynaud's phenomenon, Intolerance to olfactory and auditory stimuli, cephalgia lumbar, increased sensitivity to the side effects of drugs and paresthesia of hands and feet. To be evaluated with a questionnaire (yes/no type)
- Presence/absence of physical or psychic trigger factor of fibromyalgia [baseline (pre intervention period)]
To be evaluated with a questionnaire (yes/no type)
- Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance [baseline (pre intervention period)]
To be evaluated with a questionnaire (yes/no type)
- Presence/absence of family history of fibromyalgia [baseline (pre intervention period)]
To be evaluated with a questionnaire (yes/no type)
- presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory [baseline (pre intervention period)]
To be evaluated with a questionnaire (yes/no type)
- presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain [baseline (pre intervention period)]
To be evaluated with a questionnaire (yes/no type)
- Diagnosis date [baseline (pre intervention period)]
diagnosis date of fibromyalgia
- Years of evolution [baseline (pre intervention period)]
years of evolution of fibromyalgia
- presence/absence of pathological history: arthrosis, arthritis and mental health problems [baseline (pre intervention period)]
To be evaluated with a questionnaire (yes/no type)
- Test of the thyroid stimulating hormone [baseline (pre intervention period)]
Analytic results in milliunits per litre (mUI/L)
- Hemogram [baseline (pre intervention period)]
Analytic results of hemogram
- Glucose, creatinine and C-reactive protein tests [baseline (pre intervention period)]
Analytic results of each test in mg/dl
- Liver Function Tests [baseline (pre intervention period)]
Analytic results of each test
- Globular sedimentation rate [baseline (pre intervention period)]
Analytic results in mm
- Rheumatoid factor [baseline (pre intervention period)]
Analytic results in IU/mL
- Pharmacy billing cost [one year before the beginning of the intervention in comparison with one year after the beginning of the intervention]
antidepressants, analgesics and others
- Cost of visits [one year before the beginning of the intervention in comparison with one year after the beginning of the intervention]
cost of visits to family doctor or nurse and cost of urgency visits
- Cost of referrals [one year before the beginning of the intervention in comparison with one year after the beginning of the intervention]
cost of referrals to external consultations
- Cost of lost productivity [one year before the beginning of the intervention in comparison with one year after the beginning of the intervention]
cost of lost productivity due to sick leave
Eligibility Criteria
Criteria
Inclusion Criteria (all criteria must be met):
-
Have a clinical diagnosis of fibromyalgia
-
Have a fixed or mobile telephone
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Voluntarily accept participation in the project
Exclusion Criteria:
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Active psychotic outbreak;
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Intellectual deficiency;
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Severe depression and personality disorder;
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Self and hetero-aggressive behaviors;
-
Individual assessment of active consumption of psychoactive substances;
-
Incompatibility with the group's schedule.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Català de la Salut | Tortosa | Tarragona | Spain | 43500 |
Sponsors and Collaborators
- Jordi Gol i Gurina Foundation
- Institut Català de la Salut
- Instituto de Salud Carlos III
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI1800943