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

NCT04049006 | Completed

• 1 other identifier: PI1800943
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (20)

• Sociodemographic characteristics of the patients

  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 family history of fibromyalgia

  baseline (pre intervention period)

Study Arms (2)

complex-treatment benefiting group

EXPERIMENTAL

Participants in the intervention group will receive the complex treatment and the usual clinical practice.

Other: complex treatment

complex-treatment no benefiting group

NO INTERVENTION

Participants in the control group will receive the care from the usual clinical practice

Interventions

complex treatment OTHER

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.

complex-treatment benefiting group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a clinical diagnosis of fibromyalgia
• Have a fixed or mobile telephone
• Voluntarily accept participation in the project

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institut Català de la Salut

Tortosa, Tarragona, 43500, Spain

Location

Related Publications (7)

• 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.

  PMID: 31593081 RESULT

• 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.

  PMID: 33177139 RESULT

• 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.

  PMID: 33550259 RESULT

• 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.

  PMID: 34839810 RESULT

• 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.

  PMID: 36293900 RESULT

• Caballol Angelats R, Goncalves AQ, Abellana R, Carrasco-Querol N, Pamies Corts A, Gonzalez Serra G, Gracia Benaiges D, Sancho Sol MC, Fuste Anguera I, Chavarria Jordana S, Cuevas Baticon B, Batlle Escolies G, Fibla Reverte M, Espuny Valles N, Buera Pitarque N, Marti Cavalle M, Suazo NP, Estivill Bargallo J, Lopez Guerrero MA, Lopez Guerrero C, Perez Acin P, Matamoros Callarisa I, Baucells J, Suazo Ciurana A, Fernandez-Saez J, Dalmau Llorca MR, Berenguera A, Aguilar Martin C. Effectiveness of a Multicomponent Program for Fibromyalgia Patients in a Primary Care Setting (FIBROCARE Program): A Pragmatic Randomized Controlled Trial. J Clin Med. 2024 Dec 30;14(1):161. doi: 10.3390/jcm14010161.

  PMID: 39797245 DERIVED

• Arfuch VM, Aguilar Martin C, Berenguera A, Caballol Angelats R, Goncalves AQ, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Friberg E, Pettersson E, Casajuana M. Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial. J Rehabil Med. 2023 Dec 19;55:jrm12361. doi: 10.2340/jrm.v55.12361.

  PMID: 38111994 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: August 7, 2019
• Study Start: April 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 7, 2023

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available in the scientific publications derived from the project.
• Access Criteria: Through scientific publications in open access journals

Locations

ES (1)