Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease (NCT06136221) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
United States110 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a home-based remote monitoring tool called LiverWatch — can you explain what that actually involves day-to-day, like how often I'd need to check in or what devices I might need to use at home?
2Since this study is measuring something called PROMIS 29+2, which I understand tracks quality of life and symptoms, does that mean the main goal is to understand how I'm feeling over time rather than to treat my cirrhosis directly, and how would that affect my regular care?
3The trial focuses on things like physical inactivity and muscle loss alongside advanced liver disease — are those concerns already relevant to my situation, and would participating in this study help address them or just monitor them?
4This is listed as a Phase NA study, which I think means it's evaluating a monitoring system rather than a drug or procedure — can you help me understand what the potential risks or benefits of joining would actually be for me personally?
5Given that I have end-stage liver disease, are there standard treatments or other options I should consider before or alongside something like this, or is remote monitoring like LiverWatch something that could fit into my current care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.