RecruitingNot ApplicableNCT06136221

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

Sponsor

University of Pennsylvania

Enrollment

110 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Cirrhosis, Liver

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria9

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

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Interventions

BEHAVIORALLiverWatch 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.