Economic Burden of NAFLD

• Sponsor: Hasselt University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05035043
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 3.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease; NAFLD	Other: Determination of the economic burden NAFLD patients	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Economic Burden of Non-Alcoholic Fatty Liver Disease Patients in Flanders, Belgium
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Apr 30, 2024
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NAFLD patients Non-Alcoholic Fatty Liver Disease patients	Other: Determination of the economic burden NAFLD patients; Determination of the economic burden NAFLD patients (Healthcare costs, patient costs, burden of disease

Outcome Measures

Primary Outcome Measures

1. iMTA MCQ [baseline]

   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

1. iMTA MCQ [Baseline]

   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.

2. EuroQol-5D-5L [baseline]

   : 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasselt University	Hasselt		Belgium	3500

Sponsors and Collaborators

• Hasselt University

Investigators

• Principal Investigator: Geert Robaeys, prof. dr., Hasselt University
• Study Chair: Leen Heyens, Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geert Robaeys, Principal Investigator, Hasselt University
• ClinicalTrials.gov Identifier: NCT05035043
• Other Study ID Numbers: EB-NAFLD-DGP-001
• First Posted: Sep 5, 2021
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Financial Stress

Study Results

No Results Posted as of Apr 14, 2022