Cost-utility of the Multicomponent Program VIRTUAL FIBROWALK in Patients With Fibromyalgia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyoma;Cervix
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Client Service Receipt Inventory (CSRI)
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Client Service Receipt Inventory (CSRI)
Time Frame: Change from baseline values at 6 months
The Client Service Receipt Inventory (CSRI) is a tool used to collect information on the whole range of services and supports study participants may use. This data can be used for a wide range of applications, including estimating the costs of service receipt.
EuroQoL questionnaire (EQ-5D-5L)
Time Frame: Change from baseline values at 6 months
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: Change from baseline values at 6 months
The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.
Secondary Outcomes
- Physical Function of the 36-Item Short Form Survey (SF-36)(Change from baseline values at 6 months)
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline values at 6 months)
- Tampa Scale for Kinesiophobia (TSK-11)(Change from baseline values at 6 months)