Back to resultsEconomic Burden of NAFLD
Primary Purpose
Non-Alcoholic Fatty Liver Disease, NAFLD
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Determination of the economic burden NAFLD patients
Sponsored by
About this trial
This is an interventional other trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- having NAFLD as was diagnosed by FibroScan®,
- 18 years or older
- BMI ≥ 25 kg/m²
Exclusion Criteria:
- unable to give informed consent
- >70 years
Sites / Locations
- Hasselt UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NAFLD patients
Arm Description
Non-Alcoholic Fatty Liver Disease patients
Outcomes
Primary Outcome Measures
iMTA MCQ
Healthcare cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services.
Secondary Outcome Measures
iMTA MCQ
Patient cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services.
EuroQol-5D-5L
: Health related quality of life questionnaire EuroQol-5D-5L is used. Five levels are score in 5 dimensions. It is scaled from 0 to 100%. A higher score indicates a higher quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05035043
Brief Title
Economic Burden of NAFLD
Official Title
The Economic Burden of Non-Alcoholic Fatty Liver Disease Patients in Flanders, Belgium
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
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
To determine the economic burden of NAFLD (Non-Alcoholic-Fatty-Liver Disease) patients in Belgium, Flanders by means of a bottom-up approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, NAFLD
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NAFLD patients
Arm Type
Experimental
Arm Description
Non-Alcoholic Fatty Liver Disease patients
Intervention Type
Other
Intervention Name(s)
Determination of the economic burden NAFLD patients
Intervention Description
Determination of the economic burden NAFLD patients (Healthcare costs, patient costs, burden of disease
Primary Outcome Measure Information:
Title
iMTA MCQ
Description
Healthcare cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
iMTA MCQ
Description
Patient cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services.
Time Frame
Baseline
Title
EuroQol-5D-5L
Description
: Health related quality of life questionnaire EuroQol-5D-5L is used. Five levels are score in 5 dimensions. It is scaled from 0 to 100%. A higher score indicates a higher quality of life.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
having NAFLD as was diagnosed by FibroScan®,
18 years or older
BMI ≥ 25 kg/m²
Exclusion Criteria:
unable to give informed consent
>70 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geert Robaeys, prof. dr.
Phone
+32 89 32 65 05
Email
geert.robaeys@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Leen Heyens, drs.
Phone
+32 89 21 20 55
Email
leen.heyens@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leen Heyens
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leen Heyens, drs.
Phone
+32 89 21 20 55
Email
leen.heyens@uhasselt.be
12. IPD Sharing Statement
Learn more about this trial
Economic Burden of NAFLD
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