NCT07169526

Brief Summary

The goal of this observational study is to quantify the health literacy and self-efficacy in people with alcohol-related liver cirrhosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Aug 2025Oct 2026

Study Start

First participant enrolled

August 11, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 3, 2025

Last Update Submit

September 5, 2025

Conditions

Self-EfficacyHealth LiteracyLiver CirrhosisALD - Alcoholic Liver Disease

Outcome Measures

Primary Outcomes (2)

  • Level of self-efficacy at baseline, assessed using the Scale for General Self-Efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)

    baseline

  • Level of health literacy at baseline, assessed using the European Health Literacy Survey Questionnaire (HLS-EU-Q47)

    baseline

Secondary Outcomes (4)

  • Occurrence of hepatic decompensation or liver-related death

    until end of study

  • Rehospitalization due to liver-related complications

    Throughout study completion (up to 12 months)

  • Hepatic decompensation episodes

    Throughout study completion (up to 12 months)

  • Level of quality of life, assessed using the [e.g., SF-36 Questionnaire]

    baseline

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

people with liver cirrhosis

You may qualify if:

  • age (18-99)
  • liver cirrhosis

You may not qualify if:

  • pregnancy
  • insufficient german

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisLiver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Central Study Contacts

Benjamin Prof. Dr. med. Maasoumy, Prof. Dr. med.

CONTACT

+495115326529maasoumy.benjamin@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 11, 2025

Study Start

August 11, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

DE(1)