Status:

RECRUITING

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

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

Pennsylvania Department of Health

Conditions:

Cirrhosis, Liver

End Stage Liver DIsease

Eligibility:

All Genders

18+ years

Phase:

NA

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 investiga...

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 an...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 31 2026

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT06136221

Start Date

May 1 2024

End Date

May 31 2026

Last Update

July 30 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

2

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104