Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Pennsylvania
Study ID
NCT06136221
Status
Recruiting
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Conditions

  • Cirrhosis, Liver
  • End Stage Liver DIsease
  • Muscle Loss
  • Physical Inactivity
  • Symptoms and Signs

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LiverWatch Intervention — BEHAVIORAL
    The LiverWatch Intervention will include standard cirrhosis care and include additional components utilizing the W2H system. Details on this intervention are included in the study arm description.

Study Details

Remote healthcare monitoring for cirrhosis has shown promise in overcoming barriers to accessing specialty care, improving healthcare quality, and reducing mortality. The LiverWatch study is investigating whether a remote nutrition, physical activity, and education intervention can improve health outcomes in those with cirrhosis. In this clinical trial, individuals will be randomized to either enhanced usual care or the LiverWatch intervention. Both groups are given fitbits and asked to increase their step counts. Those in the Liverwatch group will be incentivized for increase their physical activity while also undergoing a personalized nutrition intervention and weekly symptom monitoring and cirrhosis education.

Key Dates

Start date
May 1, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Enhanced Usual Care
    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.
  • Experimental: LiverWatch 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.

Primary Outcome Measure

PROMIS 29+2 [ Time Frame: 12 Weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Samantha Nikirk, MPH
[email protected]
734-232-4182
Elliot Tapper, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Richard Mason, PharmD
[email protected]
215-662-3904
Marina Serper, MD (PRINCIPAL_INVESTIGATOR)
Shivan Mehta, MD (SUB_INVESTIGATOR)

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