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

NCT ID: NCT06136221

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-31

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.

Detailed Description

Liver cirrhosis is a chronic condition with a high symptom burden, morbidity, mortality and costs. Common symptoms and reasons for hospitalizations in cirrhosis are 'fluid overload' (e.g. abdominal and leg swelling), hepatic encephalopathy (episodic cognitive impairment), physical frailty, and infections. Pilot and feasibility data show that many of these complications may be managed remotely with patient and caregiver-directed text-messaging platforms, online portals, and frequent telephone check-ins with the clinical team. This approach can help reduce unnecessary urgent visits and hospitalizations. Malnutrition is present among an estimated 60% of patients with advanced cirrhosis, and is associated with frailty, loss of muscle mass, and hepatic encephalopathy, leading to a greater likelihood of hospitalization and poorer health-related quality of life (HRQoL). Studies show that HRQoL may improve with targeted nutritional management, yet personalized nutritional interventions are not routinely incorporated into many telehealth and remote monitoring approaches for cirrhosis. To be effective, telehealth and remote monitoring interventions must be patient-centered, feasible, acceptable, and sustainable.

The LiverWatch study is investigating whether an intervention aimed at improving physical health and wellness as well as monitor for symptoms in those with cirrhosis is an effective strategy to improve patient-centered outcomes. This study compares enhanced usual care of those with cirrhosis versus an intervention that includes a dietitian consultation, educational messages, and a step rewards program. LiverWatch leverages the use of electronic health records and Way To Health (W2H) text messages to explore its aims. LiverWatch is a 2-arm, patient-randomized controlled trial at the University of Pennsylvania. A total of 110 patients with cirrhosis aged 18 or older (n=55 per arm) will be recruited and randomized to intervention versus enhanced usual care for 12 weeks with a 12 week follow-up period. Study visits will occur at Baseline (Week 0), Week 6, and Week 12. Clinical outcomes will be measured from the electronic medical record (EMR) at Week 24. The LiverWatch intervention includes:

• Modifiable walking goals with the use of W2H and a fitbit.
• Cirrhosis, nutrition, and fitness education sent weekly via text message
• A one-one baseline visit with a registered dietitian to discuss healthy eating habits and set up individualized goals
• Remote symptom monitoring conducted via text message

The primary objective of the study is to test the effectiveness of LiverWatch. The secondary objective is to explore barriers to and facilitators of optimal implementation and scalability of LiverWatch among patients, caregivers, clinicians, and health-system administrators.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

LiverWatch Intervention

Intervention Type: 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.

Interventions

LiverWatch Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: NOT_YET_RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Richard Mason, PharmD

Role: CONTACT

richard.mason@pennmedicine.upenn.edu

215-662-3904

Marina Serper, MD

Role: CONTACT

marinas2@pennmedicine.upenn.edu

215-349-8222

Facility Contacts

Samantha Nikirk, MPH

Role: primary

samjwalk@med.umich.edu

734-232-4182

Richard Mason, PharmD

Role: primary

richard.mason@pennmedicine.edu

215-662-3904

Other Identifiers

844700

Identifier Type: -

Identifier Source: org_study_id