NCT07216807

Brief Summary

A randomized controlled trial of written text vs video education to patients with cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 15, 2025

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

September 29, 2025

Last Update Submit

October 9, 2025

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Delta knowledge scores between text and video education groups

    The delta score (post test minus pre test) was compared between text education and video education groups.

    Baseline and immediately post-intervention (Day 1)

Study Arms (4)

General cirrhosis text

OTHER

These patients received TEXT education, and the subject was general cirrhosis knowledge.

Other: Text education

General cirrhosis video

OTHER

These patients received VIDEO education, and the subject was general cirrhosis knowledge.

Other: Video Education

Decompensation text

OTHER

These patients received TEXT education, and the subject was decompensated cirrhosis knowledge.

Other: Text education

Decompensation video

OTHER

These patients received VIDEO education, and the subject was general cirrhosis knowledge.

Other: Video Education

Interventions

Video EducationOTHER

Video education was provided from the cirrhosis.ca website.

Decompensation videoGeneral cirrhosis video
Text educationOTHER

Text education was provided from the University of Michigan patient education materials

Decompensation textGeneral cirrhosis text

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis diagnosis

You may not qualify if:

  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 15, 2025

Study Start

June 1, 2023

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)