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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049006
• Other study ID #: PI1800943
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2019
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Spain	Institut Català de la Salut	Tortosa	Tarragona

Sponsors (3)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Institut Català de la Salut, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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 syndr — View 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 prim — View 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 — View 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: — View 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 multicompo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Sociodemographic characteristics of the patients	age, sex, level of education, work disability and family coexistence	baseline (pre intervention period)
Secondary	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)
Secondary	Presence/absence of physical or psychic trigger factor of fibromyalgia	To be evaluated with a questionnaire (yes/no type)	baseline (pre intervention period)
Secondary	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)
Secondary	Presence/absence of family history of fibromyalgia	To be evaluated with a questionnaire (yes/no type)	baseline (pre intervention period)
Secondary	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)
Secondary	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)
Secondary	Diagnosis date	diagnosis date of fibromyalgia	baseline (pre intervention period)
Secondary	Years of evolution	years of evolution of fibromyalgia	baseline (pre intervention period)
Secondary	presence/absence of pathological history: arthrosis, arthritis and mental health problems	To be evaluated with a questionnaire (yes/no type)	baseline (pre intervention period)
Secondary	Test of the thyroid stimulating hormone	Analytic results in milliunits per litre (mUI/L)	baseline (pre intervention period)
Secondary	Hemogram	Analytic results of hemogram	baseline (pre intervention period)
Secondary	Glucose, creatinine and C-reactive protein tests	Analytic results of each test in mg/dl	baseline (pre intervention period)
Secondary	Liver Function Tests	Analytic results of each test	baseline (pre intervention period)
Secondary	Globular sedimentation rate	Analytic results in mm	baseline (pre intervention period)
Secondary	Rheumatoid factor	Analytic results in IU/mL	baseline (pre intervention period)
Secondary	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
Secondary	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
Secondary	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
Secondary	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