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

Conditions

Fibromyalgia

Keywords

Quality of life, randomized Controlled trials, Costs and Cost analysis, Primary Health Care

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.

Rosa Caballol Angelats, Alessandra Queiroga Gonçalves, Rosa Abellana, Noèlia Carrasco-Querol, Anna Pàmies et al. (28 authors)

Journal of Clinical Medicine2024-12-305 citations

10.3390/jcm14010161

Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial

Victoria Mailen Arfuch, Carina Aguilar Martín, Anna Berenguera, Rosa Caballol Angelats, Alessandra Queiroga Gonçalves et al. (12 authors)

Journal of Rehabilitation Medicine2023-12-194 citations

10.2340/jrm.v55.12361

Cost–utility analysis of a multicomponent intervention for fibromyalgia syndrome in primary care versus usual clinical practice: study protocol for an economic evaluation of a randomised control trial

Victoria Mailen Arfuch, Carina Aguilar Martín, Anna Berenguera, Rosa Caballol Angelats, Noèlia Carrasco-Querol et al. (11 authors)

BMJ Open2021-02-014 citations

10.1136/bmjopen-2020-043562

Assessing the benefits on quality of life of a multicomponent intervention for fibromyalgia syndrome in primary care: patients’ and health professionals’ appraisals: a qualitative study protocol

Victoria Mailen Arfuch, Rosa Caballol Angelats, Carina Aguilar Martín, Noèlia Carrasco-Querol, Maria Cinta Sancho Sol et al. (9 authors)

BMJ Open2020-11-014 citations

10.1136/bmjopen-2020-039873

Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care

Rosa Caballol Angelats, Alessandra Queiroga Gonçalves, Carina Aguilar Martín, Maria Cinta Sancho Sol, Gemma González Serra et al. (11 authors)

Medicine2019-10-0118 citations

10.1097/md.0000000000017289

Interventions

OTHERcomplex 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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
Sociodemographic characteristics of the patients	baseline (pre intervention period)	age, sex, level of education, work disability and family coexistence
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
Liver Function Tests	baseline (pre intervention period)	Analytic results of each test
Presence/absence of family history of fibromyalgia	baseline (pre intervention period)	To be evaluated with a questionnaire (yes/no type)
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)
Test of the thyroid stimulating hormone	baseline (pre intervention period)	Analytic results in milliunits per litre (mUI/L)

Countries

Spain

Outcome results

None listed