Cost-utility of VIRTUAL FIBROWALK

NCT ID: NCT05091697

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2021-12-30

Brief Summary

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The main objective of this study is to assess the effectiveness and cost-utility of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as- usual (TAU) compared to TAU alone.

Detailed Description

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This is a two-arm RCT focused on the effectiveness and cost-utility of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) vs. TAU alone (in a 3-month follow-up RCT) VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

Conditions

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Fibromyoma;Cervix

Keywords

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Cost-utility Fibromyalgia multicomponent treatment randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Multicomponent treatment VIRTUAL FIBROWALK + TAU

VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training

Group Type EXPERIMENTAL

Multicomponent treatment VIRTUAL FIBROWALK + TAU

Intervention Type BEHAVIORAL

To assess the effectiveness and cost-utility of the virtual multicomponent program (Fibrowalk)

Treatment as Usual (TAU)

Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.patient

Group Type ACTIVE_COMPARATOR

Multicomponent treatment VIRTUAL FIBROWALK + TAU

Intervention Type BEHAVIORAL

To assess the effectiveness and cost-utility of the virtual multicomponent program (Fibrowalk)

Interventions

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Multicomponent treatment VIRTUAL FIBROWALK + TAU

To assess the effectiveness and cost-utility of the virtual multicomponent program (Fibrowalk)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Autonoma de Barcelona

OTHER

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayte Serrat

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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COST-UTILITY VIIRTUAL FW

Identifier Type: -

Identifier Source: org_study_id