Clinical trial NCT04049006: Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Quality of life
randomized Controlled trials
Costs and Cost analysis
Primary Health Care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Instituto de Salud Carlos III
First posted: 2019-08-07
Enrollment: 302
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in life quality
timeFrame: change from life quality at 3, 9 and 15 months after the beginning of the study
measure: Change in functional impact of fibromyalgia
timeFrame: Change from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study.
measure: Change in tender points
timeFrame: Change from tender points at 3, 9 and 15 months after the beginning of the study.
measure: Change in Visual Analog Scale for pain (VAS)
timeFrame: Change from VAS at 3, 9 and 15 months after the beginning of the study.
measure: Change in mood indicator (anxiety)
timeFrame: Change from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study.
measure: Change in mood indicator (depression)
timeFrame: Change from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study.
Secondary outcomes:
measure: Sociodemographic characteristics of the patients
timeFrame: baseline (pre intervention period)
measure: Presence/absence of physical manifestations
timeFrame: baseline (pre intervention period)
measure: Presence/absence of physical or psychic trigger factor of fibromyalgia
timeFrame: baseline (pre intervention period)
measure: Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance
timeFrame: baseline (pre intervention period)
measure: Presence/absence of family history of fibromyalgia
timeFrame: baseline (pre intervention period)
measure: presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory
timeFrame: baseline (pre intervention period)
measure: presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain
timeFrame: baseline (pre intervention period)
measure: Diagnosis date
timeFrame: baseline (pre intervention period)
measure: Years of evolution
timeFrame: baseline (pre intervention period)
measure: presence/absence of pathological history: arthrosis, arthritis and mental health problems
timeFrame: baseline (pre intervention period)
measure: Test of the thyroid stimulating hormone
timeFrame: baseline (pre intervention period)
measure: Hemogram
timeFrame: baseline (pre intervention period)
measure: Glucose, creatinine and C-reactive protein tests
timeFrame: baseline (pre intervention period)
measure: Liver Function Tests
timeFrame: baseline (pre intervention period)
measure: Globular sedimentation rate
timeFrame: baseline (pre intervention period)
measure: Rheumatoid factor
timeFrame: baseline (pre intervention period)
measure: Pharmacy billing cost
timeFrame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
measure: Cost of visits
timeFrame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
measure: Cost of referrals
timeFrame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
measure: Cost of lost productivity
timeFrame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Other outcomes:
Locations:
city: Tortosa
country: Spain
facility: Institut Català de la Salut
state: Tarragona
Study officials:
References:
citation: Caballol Angelats R, Goncalves AQ, Aguilar Martin C, Sancho Sol MC, Gonzalez Serra G, Casajuana M, Carrasco-Querol N, Fernandez-Saez J, Dalmau Llorca MR, Abellana R, Berenguera A; SensiTEbre group. Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: A mixed methods study protocol. Medicine (Baltimore). 2019 Oct;98(41):e17289. doi: 10.1097/MD.0000000000017289.
citation: Arfuch VM, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Goncalves AQ, Berenguera A. 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. BMJ Open. 2020 Nov 11;10(11):e039873. doi: 10.1136/bmjopen-2020-039873.
citation: Arfuch VM, Aguilar Martin C, Berenguera A, Caballol Angelats R, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Fernandez Saez J, Goncalves AQ, Casajuana M. 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. BMJ Open. 2021 Feb 5;11(2):e043562. doi: 10.1136/bmjopen-2020-043562.
citation: Arfuch VM, Queiroga Goncalves A, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Berenguera A. Patients' appraisals about a multicomponent intervention for fibromyalgia syndrome in primary care: a focus group study. Int J Qual Stud Health Well-being. 2021 Dec;16(1):2005760. doi: 10.1080/17482631.2021.2005760.
citation: Arfuch VM, Caballol Angelats R, Aguilar Martin C, Goncalves AQ, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Friberg E, Berenguera A. Patients' Lived Experience in a Multicomponent Intervention for Fibromyalgia Syndrome in Primary Care: A Qualitative Interview Study. Int J Environ Res Public Health. 2022 Oct 15;19(20):13322. doi: 10.3390/ijerph192013322.