LiverWatch Intervention for Cirrhosis

Recruiting at 1 trial location

Overseen By Richard Mason, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: No smartphone, Hospice care, MELD ≥30, Advanced cancer, Recent hospitalization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the LiverWatch trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How is the LiverWatch Intervention treatment for cirrhosis different from other treatments?

The LiverWatch Intervention is unique because it focuses on early detection and monitoring of liver cirrhosis using structured screening procedures, which may include liver function tests and other biomarkers, to identify advanced fibrosis and cirrhosis early on. This approach is different from traditional treatments that may not emphasize early detection and continuous monitoring. ^{1 2 3 4 5}

What data supports the effectiveness of the LiverWatch Intervention treatment for cirrhosis?

The research suggests that nurse-led outpatient care, which is part of the LiverWatch Intervention, is safe and feasible for managing chronic diseases like liver cirrhosis. This approach can help improve patient outcomes by providing educational support and guidance on preventive measures. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with advanced liver cirrhosis who live at home and can handle text messages. They should be willing to wear fitness trackers and work with the study team but not be in hospice care, have severe liver cancer, a high MELD score, recent hospitalization, or involved in other similar interventions.

Inclusion Criteria

Willing and able to wear personal fitness trackers and engage with study staff

I have severe liver disease with recent complications or hospital visits.

Must be English speaking

Exclusion Criteria

Deemed not appropriate by treating physician for medical reasons

I have been hospitalized in the last 30 days.

My liver cancer is advanced (stage BCLC C or higher).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline interviews and assessments, including malnutrition screening and distribution of Fitbits

1 week

1 visit (in-person)

Treatment

Participants receive either enhanced usual care or the LiverWatch intervention, including remote symptom monitoring, nutrition support, and physical activity incentives

12 weeks

3 visits (in-person) at Baseline, Week 6, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinical outcomes measured from the electronic medical record

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LiverWatch Intervention

Trial Overview The LiverWatch study tests if remote monitoring that includes personalized nutrition advice, physical activity incentives using Fitbits, and weekly education on cirrhosis symptoms can improve health outcomes compared to just regular care plus step count tracking.

How Is the Trial Designed?

Group I: LiverWatch Intervention Experimental Treatment 1 Intervention

Patients will undergo symptom-based monitoring with targeted nutrition support. participants in Arm 2 will also receive educational text messages related to cirrhosis and physical activity. In summary, there are four components to the * Remote Symptom Monitoring * Targeted Nutrition Assessment and Intervention * Physical Activity and Rewards Program * Motivational Messages Subjects will be enrolled in an online portal, Way to Health (W2H), which automates many of the research and monitoring functions of the intervention. Patients will receive remote symptom monitoring on a weekly basis, enhanced nutrition assistance through weekly education videos, and "motivational messages" on Mondays and Fridays that include education on diet, physical activity, and cirrhosis. Participants in this arm will also be encouraged to increase their step count using a rewards system built through the W2H.

Group II: Enhanced Usual Care Active Control 1 Intervention

Patients will undergo baseline interviews with study coordinators. All participants will be screened for malnutrition with the validated malnutrition screening tool (MST). At the baseline interview, patients will receive instructional handouts on dietary changes and recipes as per the updated 2019 European Society for Clinical Nutrition \& Metabolism (ESPEN) guidelines. Information on the resource CirrhosisCare.ca will also be provided. Participants in the control arm will receive Fitbits to monitor their steps. They will be asked to try and get up to 7000 steps per day, and no follow-up on their progress in terms of step counts will be given during the 12 weeks. All participants will be allowed to keep their Fitbit once they complete the study.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Pennsylvania Department of Health

Collaborator

Trials

42

Recruited

999,000+

Published Research Related to This Trial

Nurse-assisted follow-up care for patients with decompensated liver cirrhosis has shown potential benefits in improving health outcomes, including reduced mortality and readmission rates, based on a review of 16 studies involving 1224 participants.

Despite the observed improvements, the studies varied in quality and design, and there is currently no consensus on the most effective type of nurse-assisted intervention, highlighting the need for more rigorous, standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-assisted and multidisciplinary outpatient follow-up among patients with decompensated liver cirrhosis: A systematic review. O'Connell, MB., Bendtsen, F., Nørholm, V., et al.[2023]

In a study of 222 patients with decompensated cirrhosis, 59.4% were readmitted at least once, highlighting the high risk of readmission in this population.

Key predictors for 30-day readmission included lower education levels, the presence of hepatic encephalopathy at discharge, elevated ALT levels, and Medicare coverage, indicating areas for targeted interventions to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital readmissions in decompensated cirrhotics: Factors pointing toward a prevention strategy. Seraj, SM., Campbell, EJ., Argyropoulos, SK., et al.[2018]

A comprehensive review led to the identification of 46 key quality measures for cirrhosis care, including 26 process measures, 7 clinical outcome measures, and 13 patient-reported outcome measures, aimed at improving care quality for adults with cirrhosis.

These evidence-based measures, validated in a study involving 79 patients across nine U.S. institutions, provide a framework for healthcare providers to assess and enhance the quality of cirrhosis treatment in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Quality Measures in Cirrhosis by the Practice Metrics Committee of the American Association for the Study of Liver Diseases. Kanwal, F., Tapper, EB., Ho, C., et al.[2020]

From 2002 to 2010, inpatient mortality rates for patients with cirrhosis significantly decreased from 9.1% to 5.4%, indicating improved outcomes for this patient group, which may be linked to better care practices.

Despite the increasing age and complexity of patients with cirrhosis, the independent mortality risk ratio improved to 0.50 by 2010, suggesting that advancements in cirrhosis management have positively impacted survival rates, although sepsis remains a critical area needing further attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. Schmidt, ML., Barritt, AS., Orman, ES., et al.[2022]

In a study of 14,976 patients with liver cirrhosis, 38% had one or more comorbidities, which significantly increased their mortality risk; the 1-year survival probability was 65.5% and the 10-year survival probability was only 21.5%.

Patients with higher comorbidity scores had progressively higher mortality rates, with a two-fold increase in risk for those with a score of 3 or more, indicating that managing comorbid conditions, especially in the first year after cirrhosis diagnosis, could greatly improve survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidity and survival of Danish cirrhosis patients: a nationwide population-based cohort study. Jepsen, P., Vilstrup, H., Andersen, PK., et al.[2022]

The SEAL (Structured Early detection of Asymptomatic Liver cirrhosis) screening program can effectively detect advanced liver fibrosis and cirrhosis in the general population at moderate costs, ranging from EUR 5.99 to 13.74 per participant.

The most common cause of liver disease detected in this screening was non-alcoholic fatty liver disease, accounting for 60% of cases, highlighting the importance of early detection in managing this prevalent condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs of a structured early detection program for advanced liver fibrosis and cirrhosis: insights on the "plus" of Check-up 35. Ortner, J., Van Ewijk, RJ., Velthuis, L., et al.[2023]

The prevalence of liver cirrhosis in the U.S. is approximately 0.27%, affecting around 633,323 adults, with a significant number (69%) unaware of their condition.

Key risk factors for cirrhosis include diabetes, alcohol abuse, and viral hepatitis, which together account for over half of the cases, indicating that many instances of cirrhosis could be preventable through targeted public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Epidemiology of Cirrhosis in the United States: A Population-based Study. Scaglione, S., Kliethermes, S., Cao, G., et al.[2022]

A study involving 126,925 individuals in Stockholm showed that combining age, the FIB-4 score, diabetes status, and gamma-glutamyl transferase (gGT) levels significantly improves the identification of individuals at risk for severe liver disease, including cirrhosis.

The research identified 24 distinct risk profiles, with a 10-year cumulative incidence of severe liver disease ranging from 0.2% to 32.1%, highlighting the importance of using common biomarkers to enhance existing prediction tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved prediction of 10-year risk of severe liver disease in the general population using commonly available biomarkers. Hagström, H., Yan, J., Talbäck, M., et al.[2023]

The portable FibroScan® device was successfully used in a community alcohol support service, with a 67% uptake among participants, indicating it is an acceptable screening tool for chronic liver disease.

Of the 76 participants scanned, 26% had readings indicating possible chronic liver disease, and all of those referred for further assessment engaged with the nurse-led clinic, demonstrating high compliance and potential for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-led FibroScan® outreach clinic encourages socially deprived heavy drinkers to engage with liver services. Matthews, K., MacGilchrist, A., Coulter-Smith, M., et al.[2019]

Cirrhosis of the liver is considered a premalignant condition with an annual risk of developing hepatocellular carcinoma (HCC) ranging from 1% to 6%, highlighting the importance of early detection.

While controlled trials are needed to confirm the efficacy of surveillance programs, current evidence suggests that regular screening can identify small, treatable tumors in high-risk patients, and it is recommended to conduct semi-annual screenings using liver ultrasound and serum alpha-fetoprotein (AFP) measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hepatocellular carcinoma: risk groups--screening]. Maier, KP.[2008]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Nurse-assisted and multidisciplinary outpatient follow-up among patients with decompensated liver cirrhosis: A systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Hospital readmissions in decompensated cirrhotics: Factors pointing toward a prevention strategy. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Development of Quality Measures in Cirrhosis by the Practice Metrics Committee of the American Association for the Study of Liver Diseases. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comorbidity and survival of Danish cirrhosis patients: a nationwide population-based cohort study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Costs of a structured early detection program for advanced liver fibrosis and cirrhosis: insights on the "plus" of Check-up 35. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Epidemiology of Cirrhosis in the United States: A Population-based Study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Improved prediction of 10-year risk of severe liver disease in the general population using commonly available biomarkers. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A nurse-led FibroScan® outreach clinic encourages socially deprived heavy drinkers to engage with liver services. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Hepatocellular carcinoma: risk groups--screening]. [2008]