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NCT06136221
Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
Conditions: Cirrhosis, Liver, End Stage Liver DIsease, Symptoms and Signs, Physical Inactivity, Muscle Loss
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: University of Pennsylvania
Location: University of Michigan Ann Arbor Michigan
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 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
Source: ClinicalTrials.gov (NCT06136221). StuddyBuddy aggregates publicly available trial information.