NCT06136221 Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
| NCT ID | NCT06136221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Cirrhosis, Liver |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-05-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06136221 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cirrhosis, Liver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06136221 currently recruiting?
Yes, NCT06136221 is actively recruiting participants. Contact the research team at richard.mason@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06136221 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Philadelphia, United States.
Who is sponsoring the NCT06136221 clinical trial?
NCT06136221 is sponsored by University of Pennsylvania. The trial plans to enroll 110 participants.