NCT06136221

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Liver cirrhosis is a chronic condition with a high symptom burden, morbidity, mortality and costs. Common symptoms and reasons for hospitalizations in cirrhosis are 'fluid overload' (e.g. abdominal and leg swelling), hepatic encephalopathy (episodic cognitive impairment), physical frailty, and infections. Pilot and feasibility data show that many of these complications may be managed remotely with patient and caregiver-directed text-messaging platforms, online portals, and frequent telephone check-ins with the clinical team. This approach can help reduce unnecessary urgent visits and hospitalizations. Malnutrition is present among an estimated 60% of patients with advanced cirrhosis, and is associated with frailty, loss of muscle mass, and hepatic encephalopathy, leading to a greater likelihood of hospitalization and poorer health-related quality of life (HRQoL). Studies show that HRQoL may improve with targeted nutritional management, yet personalized nutritional interventions are not routinely incorporated into many telehealth and remote monitoring approaches for cirrhosis. To be effective, telehealth and remote monitoring interventions must be patient-centered, feasible, acceptable, and sustainable. The LiverWatch study is investigating whether an intervention aimed at improving physical health and wellness as well as monitor for symptoms in those with cirrhosis is an effective strategy to improve patient-centered outcomes. This study compares enhanced usual care of those with cirrhosis versus an intervention that includes a dietitian consultation, educational messages, and a step rewards program. LiverWatch leverages the use of electronic health records and Way To Health (W2H) text messages to explore its aims. LiverWatch is a 2-arm, patient-randomized controlled trial at the University of Pennsylvania. A total of 110 patients with cirrhosis aged 18 or older (n=55 per arm) will be recruited and randomized to intervention versus enhanced usual care for 12 weeks with a 12 week follow-up period. Study visits will occur at Baseline (Week 0), Week 6, and Week 12. Clinical outcomes will be measured from the electronic medical record (EMR) at Week 24. The LiverWatch intervention includes: * Modifiable walking goals with the use of W2H and a fitbit. * Cirrhosis, nutrition, and fitness education sent weekly via text message * A one-one baseline visit with a registered dietitian to discuss healthy eating habits and set up individualized goals * Remote symptom monitoring conducted via text message The primary objective of the study is to test the effectiveness of LiverWatch. The secondary objective is to explore barriers to and facilitators of optimal implementation and scalability of LiverWatch among patients, caregivers, clinicians, and health-system administrators.

Conditions

• Cirrhosis, Liver
• End Stage Liver DIsease
• Symptoms and Signs
• Physical Inactivity
• Muscle Loss

Interventions

Type	Name	Description
BEHAVIORAL	LiverWatch 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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-01-31
• Completion: 2026-05-31
• First posted: 2023-11-18
• Last updated: 2025-07-30

Locations

2 sites across 1 country: United States