Back to resultsCost-utility of VIRTUAL FIBROWALK
Primary Purpose
Fibromyoma;Cervix
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent treatment VIRTUAL FIBROWALK + TAU
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyoma;Cervix focused on measuring Cost-utility, Fibromyalgia, multicomponent treatment, randomized controlled trial
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.
Sites / Locations
- Mayte Serrat
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multicomponent treatment VIRTUAL FIBROWALK + TAU
Treatment as Usual (TAU)
Arm Description
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
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
Outcomes
Primary Outcome Measures
Revised Fibromyalgia Impact Questionnaire (FIQR)
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.
Client Service Receipt Inventory (CSRI)
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)
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.
Secondary Outcome Measures
Tampa Scale for Kinesiophobia (TSK-11)
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Hospital Anxiety and Depression Scale (HADS)
HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.
Physical Function of the 36-Item Short Form Survey (SF-36)
Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.
Full Information
NCT ID
NCT05091697
First Posted
October 13, 2021
Last Updated
December 8, 2021
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Universitat Autonoma de Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT05091697
Brief Title
Cost-utility of VIRTUAL FIBROWALK
Official Title
Cost-utility of the Multicomponent Program VIRTUAL FIBROWALK in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Universitat Autonoma de Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyoma;Cervix
Keywords
Cost-utility, Fibromyalgia, multicomponent treatment, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multicomponent treatment VIRTUAL FIBROWALK + TAU
Arm Type
Experimental
Arm Description
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Multicomponent treatment VIRTUAL FIBROWALK + TAU
Intervention Description
To assess the effectiveness and cost-utility of the virtual multicomponent program (Fibrowalk)
Primary Outcome Measure Information:
Title
Revised Fibromyalgia Impact Questionnaire (FIQR)
Description
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.
Time Frame
Change from baseline values at 6 months
Title
Client Service Receipt Inventory (CSRI)
Description
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.
Time Frame
Change from baseline values at 6 months
Title
EuroQoL questionnaire (EQ-5D-5L)
Description
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.
Time Frame
Change from baseline values at 6 months
Secondary Outcome Measure Information:
Title
Tampa Scale for Kinesiophobia (TSK-11)
Description
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Time Frame
Change from baseline values at 6 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.
Time Frame
Change from baseline values at 6 months
Title
Physical Function of the 36-Item Short Form Survey (SF-36)
Description
Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.
Time Frame
Change from baseline values at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mayte Serrat
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Cost-utility of VIRTUAL FIBROWALK
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