Liver CirrhosisNCT06745843
Liver Cirrhosis Patients' Digital Health Literacy and Perspective on Digital Healthcare, a Multicenter Questionnaire Study
A study testing Questionnaire in people with Liver Cirrhosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Objection to be approached for scientific studies requests, documented in electronic patient record
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Liver Cirrhosis
- Being tested
- Questionnaire
- Keywords
- health literacy
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The patient information, informed consent form and questionnaire will collectively be distributed digitally or by mail to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | Questionnaire sent to patients Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Health Literacy Instrument 2.0 scores
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.
Measured: At time of enrollment, single point in time.
Number of right answers on digital health visualization questionnaire.
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.
Measured: At time of enrollment, single point in time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Feb 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gelre Hospitals
- Responsible party
- Sponsor
- Investigators
- Tom Gevers, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745843
- Sponsor's protocol ID
- 2024-0454
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Cirrhosis Patients' Digital Health Literacy and Perspective on Digital Healthcare, a Multicenter Questionnaire Study
- ClinicalTrials.gov ID
- NCT06745843
- Acronym / sponsor ID
- 2024-0454
- Conditions
- Liver Cirrhosis
- Keywords
- health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Gelre Hospitals
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Other: QuestionnaireQuestionnaire sent to patients |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Objection to be approached for scientific studies requests, documented in electronic patient record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe patient information, informed consent form and questionnaire will collectively be distributed digitally or by mail to all patients. | Other | Participants |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Foundation for collaborative development of e-Health tools for different chronic diseases.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Gevers, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Liver Cirrhosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Health Literacy Instrument 2.0 scores (time frame: At time of enrollment, single point in time.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.