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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: complex treatment


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: complex-treatment benefiting group<br>Participants in the intervention group will receive the complex treatment and the usual clinical practice. | Other: complex treatment<br>* 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.<br>|
| No Intervention: complex-treatment no benefiting group<br>Participants in the control group will receive the care from the usual clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in life quality | to be evaluated with the health questionnaire (SF-36v2). It will be measured by a scale Likert: 0 (worst) to 100 (best). | change from life quality at 3, 9 and 15 months after the beginning of the study | 
| Change in functional impact of fibromyalgia | 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 from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study. | 
| Change in tender points | 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 from tender points at 3, 9 and 15 months after the beginning of the study. | 
| Change in Visual Analog Scale for pain (VAS) | The VAS evaluates the self-perceived intensity of pain by a scale Likert: 0 (absence of pain) to 10 (worst possible pain). | Change from VAS at 3, 9 and 15 months after the beginning of the study. | 
| Change in mood indicator (anxiety) | 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 from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study. | 
| Change in mood indicator (depression) | 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 from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic characteristics of the patients | age, sex, level of education, work disability and family coexistence | baseline (pre intervention period) | 
| Presence/absence of physical manifestations | 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) | baseline (pre intervention period) | 
| Presence/absence of physical or psychic trigger factor of fibromyalgia | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | 
| Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | 
| Presence/absence of family history of fibromyalgia | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | 
| presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | 
| presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | 
| Diagnosis date | diagnosis date of fibromyalgia | baseline (pre intervention period) | 
| Years of evolution | years of evolution of fibromyalgia | baseline (pre intervention period) | 
| presence/absence of pathological history: arthrosis, arthritis and mental health problems | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | 
| Test of the thyroid stimulating hormone | Analytic results in milliunits per litre (mUI/L) | baseline (pre intervention period) | 
| Hemogram | Analytic results of hemogram | baseline (pre intervention period) | 
| Glucose, creatinine and C-reactive protein tests | Analytic results of each test in mg/dl | baseline (pre intervention period) | 
| Liver Function Tests | Analytic results of each test | baseline (pre intervention period) | 
| Globular sedimentation rate | Analytic results in mm | baseline (pre intervention period) | 
| Rheumatoid factor | Analytic results in IU/mL | baseline (pre intervention period) | 
| Pharmacy billing cost | antidepressants, analgesics and others | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention | 
| Cost of visits | cost of visits to family doctor or nurse and cost of urgency visits | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention | 
| Cost of referrals | cost of referrals to external consultations | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention | 
| Cost of lost productivity | cost of lost productivity due to sick leave | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, randomized Controlled trials, Costs and Cost analysis, Primary Health Care