Self-EfficacyGESANCT07169526
Health Literacy and Self-efficacy Expectations in Patients With Alcohol-related Liver Cirrhosis
An observational study of Self-Efficacy and Health Literacy, run by Hannover Medical School at 1 site in Germany.
Trial summary
The goal of this observational study is to quantify the health literacy and self-efficacy in people with alcohol-related liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-Efficacy, Health Literacy, Liver Cirrhosis
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 11 Aug 2025to Oct 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: people with liver cirrhosis
Who may be able to join
- age (18-99)
- liver cirrhosis
Who cannot join
- pregnancy
- insufficient german
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Benjamin Prof. Dr. med. Maasoumy, Prof. Dr. med. contact
Germany1 site, 1 recruiting
- Recruiting
Medizinische Hochschule Hannover
Hanover
Benjamin Prof. Dr. med. Maasoumy, Prof. Dr. med., +495115326529, maasoumy.benjamin@mh-hannover.de
About this study
Official title: 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.
- Medical subject headings
- Liver Cirrhosis, Liver Diseases, Alcoholic
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of self-efficacy at baseline, assessed using the Scale for General Self-Efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
Measured: baseline
Level of health literacy at baseline, assessed using the European Health Literacy Survey Questionnaire (HLS-EU-Q47)
Measured: baseline
Secondary outcomes (4)
Occurrence of hepatic decompensation or liver-related death
Measured: until end of study
Rehospitalization due to liver-related complications
Measured: Throughout study completion (up to 12 months)
Hepatic decompensation episodes
Measured: Throughout study completion (up to 12 months)
Level of quality of life, assessed using the [e.g., SF-36 Questionnaire]
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start11 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-EfficacyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169526
- Sponsor's protocol ID
- 12014-BO-K-2025
- Other IDs
- 12014-BO-K-2025
- Acronym
- GESA
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gesundheitskompetenz Und Selbstwirksamkeitserwartung Bei PatientInnen Mit Alkoholbedingter Leberzirrhose
- ClinicalTrials.gov ID
- NCT07169526
- Acronym / sponsor ID
- GESA / 12014-BO-K-2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Sep 2025 (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 observational study is to quantify the health literacy and self-efficacy in people with alcohol-related liver cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people with liver cirrhosis
Key inclusion criteria (2 listed)
- age (18-99)
- liver cirrhosis
Key exclusion criteria (2 listed)
- pregnancy
- insufficient german
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of self-efficacy at baseline, assessed using the Scale for General Self-Efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
Time frame: baseline
Level of health literacy at baseline, assessed using the European Health Literacy Survey Questionnaire (HLS-EU-Q47)
Time frame: baseline
4 secondary outcomes
Occurrence of hepatic decompensation or liver-related death
Time frame: until end of study
Rehospitalization due to liver-related complications
Time frame: Throughout study completion (up to 12 months)
Hepatic decompensation episodes
Time frame: Throughout study completion (up to 12 months)
Level of quality of life, assessed using the [e.g., SF-36 Questionnaire]
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
Benjamin Prof. Dr. med. Maasoumy, Prof. Dr. med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-Efficacy and Health Literacy, run by Hannover Medical School at 1 site in Germany.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Prof. Dr. med. Maasoumy, Prof. Dr. med. (+495115326529, maasoumy.benjamin@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of self-efficacy at baseline, assessed using the Scale for General Self-Efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung) (time frame: baseline). 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 11 Sep 2025.