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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Richard Mason, PharmD
richard.mason@pennmedicine.upenn.edu
215-662-3904
Backup
Marina Serper, MD
marinas2@pennmedicine.upenn.edu
215-349-8222
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 110
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: Pennsylvania Department of Health

This content was sourced from clinicaltrials.gov