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

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

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).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: complex treatment

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 Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Tortosa, Tarragona, Spain, 43500
      • Institut Català de la Salut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Institut Català de la Salut; Instituto de Salud Carlos III

Publications and helpful links

General Publications

• 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. Erratum In: Medicine (Baltimore). 2019 Nov;98(48):e18263.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Quality of life; Primary Health Care; randomized Controlled trials; Costs and Cost analysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PI1800943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Some individual participant data collected during the qualitative phase of the study, after deidentification, will be published in articles. Some articles were already published.

Grouped (not individual) participant data that underlie the quantitative results of the trial (and also qualitative results) will be published in text, tables, or figures. The quantitative results were not yet published.

Study protocols and patients' qualitative data of this project were already published.

• IPD Sharing Time Frame: The data will be available in the scientific publications derived from the project.
• IPD Sharing Access Criteria: Through scientific publications in open access journals
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No