RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-01
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06136221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaking
  2. * Aged 18 years or older
  3. * Home-dwelling
  4. * 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)
  5. * Patient and/or caregiver is able and willing to receive SMS text messages
  6. * Willing and able to wear personal fitness trackers and engage with study staff
  1. * No access to a smartphone
  2. * Non-home dwelling
  3. * On hospice care
  4. * Model for end stage liver disease (MELD) score ≥30
  5. * Advanced hepatocellular carcinoma, BCLC C or higher
  6. * Hospitalization within the last 30 days
  7. * Deemed not appropriate by treating physician for medical reasons
  8. * Enrolled in other dietary or physical activity interventions
  9. * Receiving physical therapy as standard of care

Contacts and Locations

Study Contact

Richard Mason, PharmD
CONTACT
215-662-3904
richard.mason@pennmedicine.upenn.edu
Marina Serper, MD
CONTACT
215-349-8222
marinas2@pennmedicine.upenn.edu

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • Telehealth
  • Remote Symptom Monitoring
  • Gamification

Additional Relevant MeSH Terms

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