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Behavioral Intervention

LiverWatch Intervention for Cirrhosis

N/A

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of cirrhosis- Child Turcotte-Pugh (CTP) B or C or a complication in the past 6 months (CTP B or higher, hepatic encephalopathy, variceal bleeding, fluid overload, liver-related hospitalization, or requiring symptom management with diuretics, non-absorbable disaccharides, rifaximin, nonselective beta blockers)

Be older than 18 years old

Must not have

Hospitalization within the last 30 days

Advanced hepatocellular carcinoma, BCLC C or higher

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use remote monitoring to improve cirrhosis outcomes, providing incentives to increase physical activity, personalized nutrition guidance, and education.

Who is the study for?

This trial is for English-speaking adults with advanced liver cirrhosis who live at home and can handle text messages. They should be willing to wear fitness trackers and work with the study team but not be in hospice care, have severe liver cancer, a high MELD score, recent hospitalization, or involved in other similar interventions.

What is being tested?

The LiverWatch study tests if remote monitoring that includes personalized nutrition advice, physical activity incentives using Fitbits, and weekly education on cirrhosis symptoms can improve health outcomes compared to just regular care plus step count tracking.

What are the potential side effects?

Since this intervention involves lifestyle changes rather than medication, side effects may include muscle soreness from increased activity or dietary adjustments. However specific side effects are not detailed as it's non-pharmacological.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe liver disease with recent complications or hospital visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been hospitalized in the last 30 days.

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My liver cancer is advanced (stage BCLC C or higher).

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I am currently receiving hospice care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PROMIS 29+2

Secondary study objectives

30-Second Chair Test

Automated Self-Administered 24-hour Dietary Assessment Tool

Average Daily Step Count

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LiverWatch InterventionExperimental Treatment1 Intervention

Patients will undergo symptom-based monitoring with targeted nutrition support. participants in Arm 2 will also receive educational text messages related to cirrhosis and physical activity. In summary, there are four components to the * Remote Symptom Monitoring * Targeted Nutrition Assessment and Intervention * Physical Activity and Rewards Program * Motivational Messages Subjects will be enrolled in an online portal, Way to Health (W2H), which automates many of the research and monitoring functions of the intervention. Patients will receive remote symptom monitoring on a weekly basis, enhanced nutrition assistance through weekly education videos, and "motivational messages" on Mondays and Fridays that include education on diet, physical activity, and cirrhosis. Participants in this arm will also be encouraged to increase their step count using a rewards system built through the W2H.

Group II: Enhanced Usual CareActive Control1 Intervention

Patients will undergo baseline interviews with study coordinators. All participants will be screened for malnutrition with the validated malnutrition screening tool (MST). At the baseline interview, patients will receive instructional handouts on dietary changes and recipes as per the updated 2019 European Society for Clinical Nutrition \& Metabolism (ESPEN) guidelines. Information on the resource CirrhosisCare.ca will also be provided. Participants in the control arm will receive Fitbits to monitor their steps. They will be asked to try and get up to 7000 steps per day, and no follow-up on their progress in terms of step counts will be given during the 12 weeks. All participants will be allowed to keep their Fitbit once they complete the study.

0 / 4Eligibility criteria met