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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Change in tender points
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(all criteria must be met):
- •Have a clinical diagnosis of fibromyalgia
- •Have a fixed or mobile telephone
- •Voluntarily accept participation in the project
排除标准
- •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.
结局指标
主要结局
Change in tender points
时间窗: 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 functional impact of fibromyalgia
时间窗: 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 Visual Analog Scale for pain (VAS)
时间窗: 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 (depression)
时间窗: 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).
Change in life quality
时间窗: 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 mood indicator (anxiety)
时间窗: 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).
次要结局
- presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain(baseline (pre intervention period))
- Liver Function Tests(baseline (pre intervention period))
- Globular sedimentation rate(baseline (pre intervention period))
- Presence/absence of physical manifestations(baseline (pre intervention period))
- Presence/absence of physical or psychic trigger factor of fibromyalgia(baseline (pre intervention period))
- Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance(baseline (pre intervention period))
- presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory(baseline (pre intervention period))
- presence/absence of pathological history: arthrosis, arthritis and mental health problems(baseline (pre intervention period))
- Cost of lost productivity(one year before the beginning of the intervention in comparison with one year after the beginning of the intervention)
- Sociodemographic characteristics of the patients(baseline (pre intervention period))
- Presence/absence of family history of fibromyalgia(baseline (pre intervention period))
- Diagnosis date(baseline (pre intervention period))
- Years of evolution(baseline (pre intervention period))
- Test of the thyroid stimulating hormone(baseline (pre intervention period))
- Rheumatoid factor(baseline (pre intervention period))
- Cost of visits(one year before the beginning of the intervention in comparison with one year after the beginning of the intervention)
- Hemogram(baseline (pre intervention period))
- Glucose, creatinine and C-reactive protein tests(baseline (pre intervention period))
- Pharmacy billing cost(one year before the beginning of the intervention in comparison with one year after the beginning of the intervention)
- Cost of referrals(one year before the beginning of the intervention in comparison with one year after the beginning of the intervention)