- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07169526
- Original Trial
Health Literacy and Self-efficacy Expectations in Patients With Alcohol-related Liver Cirrhosis (GESA)
September 5, 2025 updated by: Hannover Medical School
Gesundheitskompetenz Und Selbstwirksamkeitserwartung Bei PatientInnen Mit Alkoholbedingter Leberzirrhose
The goal of this observational study is to quantify the health literacy and self-efficacy in people with alcohol-related liver cirrhosis.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin Prof. Dr. med. Maasoumy, Prof. Dr. med.
- Phone Number: +495115326529
- Email: maasoumy.benjamin@mh-hannover.de
Study Locations
-
-
-
Hanover, Germany
- Recruiting
- Medizinische Hochschule Hannover
-
Contact:
- Benjamin Prof. Dr. med. Maasoumy, Prof. Dr. med.
- Phone Number: +495115326529
- Email: maasoumy.benjamin@mh-hannover.de
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
people with liver cirrhosis
Description
Inclusion Criteria:
- age (18-99)
- liver cirrhosis
Exclusion Criteria:
- pregnancy
- insufficient german
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Level of self-efficacy at baseline, assessed using the Scale for General Self-Efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
Time Frame: baseline
|
baseline
|
|
Level of health literacy at baseline, assessed using the European Health Literacy Survey Questionnaire (HLS-EU-Q47)
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Occurrence of hepatic decompensation or liver-related death
Time Frame: until end of study
|
until end of study
|
|
Rehospitalization due to liver-related complications
Time Frame: Throughout study completion (up to 12 months)
|
Throughout study completion (up to 12 months)
|
|
Hepatic decompensation episodes
Time Frame: Throughout study completion (up to 12 months)
|
Throughout study completion (up to 12 months)
|
|
Level of quality of life, assessed using the [e.g., SF-36 Questionnaire]
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 11, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
September 3, 2025
First Submitted That Met QC Criteria
September 5, 2025
First Posted (Estimated)
September 11, 2025
Study Record Updates
Last Update Posted (Estimated)
September 11, 2025
Last Update Submitted That Met QC Criteria
September 5, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12014-BO-K-2025 (Other Identifier: Ethikkomission Medizinsiche Hochschule Hannover)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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