- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06745843
Liver Cirrhosis Patients' Digital Health Literacy and Perspective on Digital Healthcare, a Multicenter Questionnaire Study
September 25, 2025 updated by: Maastricht University Medical Center
The goal of this study is to investigate digital health literacy in liver cirrhosis patients.
Participants will fill in two questionnaires by email or mail.
Study Overview
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Maastricht, Netherlands
- Maastricht University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
- Age 18 years or older
- Treated at Gastroenterology department
Exclusion Criteria:
- Objection to be approached for scientific studies requests, documented in electronic patient record
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Participants
Questionnaire sent to patients
|
The patient information, informed consent form and questionnaire will collectively be distributed digitally or by mail to all patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital Health Literacy Instrument 2.0 scores
Time Frame: At time of enrollment, single point in time.
|
Digital health literacy Instrument (DHLI) 2.0 has 24 self-report items.
People score how difficult they perceive certain tasks to be and how often they experience certain problems on the Internet.
Each item was scored on a 4-point scale, with response options ranging from "very easy" to "very difficult" and from "never" to "often."
Scores are reversed, so that a higher score represented a higher level of digital health literacy.
|
At time of enrollment, single point in time.
|
|
Number of right answers on digital health visualization questionnaire.
Time Frame: At time of enrollment, single point in time.
|
This is a questionnaire with items assessing health visualization literacy.
People are shown 20 visualizations with information about their disease and answer a question to test if they understood the information in the visualization.
The scores consist of number of right answers, so a higher score represent better digital health visualization.
|
At time of enrollment, single point in time.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tom Gevers, MD, PhD, Maastricht University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2025
Primary Completion (Actual)
August 1, 2025
Study Completion (Actual)
August 1, 2025
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 17, 2024
First Posted (Actual)
December 20, 2024
Study Record Updates
Last Update Posted (Estimated)
September 26, 2025
Last Update Submitted That Met QC Criteria
September 25, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Digestive System Diseases
- Liver Diseases
- Fibrosis
- Pathological Conditions, Signs and Symptoms
- Liver Cirrhosis
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 2024-0454
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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