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

NCT06136221 | Recruiting

• 1 other identifier: 844700
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Telehealth; Remote Symptom Monitoring; Gamification

Outcome Measures

Primary Outcomes (1)

• PROMIS 29+2

  The PROMIS 29+2 assessment measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). There are four questions asked for each of the domains along with the two questions pertaining to cognition. These domains are measured on a Likert scale (units: 1-5) and are universal regardless of disease state.

  12 Weeks

Secondary Outcomes (8)

• Automated Self-Administered 24-hour Dietary Assessment Tool

  12 Weeks

• Average Daily Step Count

  12 Weeks

• MoCA for the Blind

  12 Weeks

• Simplified Animal Naming Test (S-ANT)

  12 Weeks

• Grip Strength

  12 Weeks

Study Arms (2)

Enhanced Usual Care

NO 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.

LiverWatch Intervention

EXPERIMENTAL

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.

Behavioral: LiverWatch Intervention

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.

LiverWatch Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Aged 18 years or older
• Home-dwelling
• 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)
• Patient and/or caregiver is able and willing to receive SMS text messages
• Willing and able to wear personal fitness trackers and engage with study staff

You may not qualify if:

• No access to a smartphone
• Non-home dwelling
• On hospice care
• Model for end stage liver disease (MELD) score ≥30
• Advanced hepatocellular carcinoma, BCLC C or higher
• Hospitalization within the last 30 days
• Deemed not appropriate by treating physician for medical reasons
• Enrolled in other dietary or physical activity interventions
• Receiving physical therapy as standard of care

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pennsylvania Department of Health: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; End Stage Liver Disease; Signs and Symptoms; Sedentary Behavior; Muscular Atrophy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Behavior; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Central Study Contacts

Richard Mason, PharmD

CONTACT

215-662-3904; richard.mason@pennmedicine.upenn.edu

Marina Serper, MD

CONTACT

215-349-8222; marinas2@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a longitudinal intervention study utilizing diverse cohorts of patients with cirrhosis. It is a 2-arm, patient-randomized controlled trial.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 18, 2023
• Study Start: May 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (2)