Home-based remote monitoring for advanced liver disease
Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
This study is testing if a new home-based program that includes nutrition help and symptom check-ins can improve the health and quality of life for people with cirrhosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT06136221 on ClinicalTrials.gov |
What this trial studies
The LiverWatch intervention aims to improve health outcomes for individuals with cirrhosis through a home-based remote monitoring approach. Participants will be randomized to receive either enhanced usual care or the LiverWatch intervention, which includes personalized nutrition support, physical activity incentives, and weekly symptom monitoring. Both groups will use fitness trackers to encourage increased physical activity. This study seeks to determine if a patient-centered telehealth approach can effectively manage symptoms and improve quality of life for those with advanced liver disease.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18 or older with a diagnosis of cirrhosis who can engage with remote monitoring tools.
Not a fit: Patients on hospice care, with advanced liver cancer, or those with a MELD score of 30 or higher are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and health outcomes for patients with cirrhosis.
How similar studies have performed: Previous studies have shown promise in using remote monitoring and telehealth interventions for managing chronic conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Richard Mason, PharmD
- Email: richard.mason@pennmedicine.upenn.edu
- Phone: 215-662-3904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.