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

May 7, 2026 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • University of Michigan
        • Principal Investigator:
          • Elliot Tapper, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Marina Serper, MD
        • Sub-Investigator:
          • Shivan Mehta, MD
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Enhanced Usual Care
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.
Experimental: LiverWatch 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PROMIS 29+2
Time Frame: 12 Weeks
The PROMIS 29+2 assessment measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). There are four questions asked for each of the domains along with the two questions pertaining to cognition. These domains are measured on a Likert scale (units: 1-5) and are universal regardless of disease state.
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Automated Self-Administered 24-hour Dietary Assessment Tool
Time Frame: 12 Weeks
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a free, web-based application that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or food diaries. The ASA24 consists of two websites. The ASA24 respondent website guides participants through the completion of either 24-hour recalls or food records. The calories consumed from these meals will be measured.
12 Weeks
Average Daily Step Count
Time Frame: 12 Weeks
The average daily step count will be measured in both groups longitudinally over 12 weeks using Fitbit.
12 Weeks
MoCA for the Blind
Time Frame: 12 Weeks
We will assess global cognition with the Montreal Cognitive Assessment (MoCA), a well-validated cognitive assessment used in diverse clinical settings and validated in liver disease. The MoCA for the Blind version can be administered remotely over the phone to participants. Participant performance is measured on a scale of 0-30.
12 Weeks
Simplified Animal Naming Test (S-ANT)
Time Frame: 12 Weeks
The Simplified Animal Naming Test (S-ANT) is a cognitive assessment used to assess semantic fluency that becomes impaired in hepatic encephalopathy. Participants have 60 seconds to name as many animals as they can without repeating names. The number of animals named by participants during this time frame will be counted.
12 Weeks
Days Alive and Out of Hospital (DAOH)
Time Frame: 24 Weeks
The number of days a patient spends alive and not hospitalized for any reason.
24 Weeks
Grip Strength
Time Frame: 12 Weeks
Grip strength is assessed using the participant's dominant hand with the Jamar+® Digital Dynamometer. Units are in lbs., and an average of 3 age- and sex-adjusted measures is calculated.
12 Weeks
Balance
Time Frame: 12 Weeks
Balance is assessed with the participant performing three different stances (feet side-by-side, semi-tandem, and tandem). The length of time a participant is able to maintain these stances is measured in seconds, up to 10 seconds for each stance.
12 Weeks
30-Second Chair Test
Time Frame: 12 Weeks
The 30-Second Chair Stand test is a measure of leg strength and endurance. The patient is asked to move from a seated position with arms crossed over the into the standing position and then sit back down. The test administrator counts the number of times the patient comes to a full standing position in 30 seconds. The number of successful completions indicates the risk of fall.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pennsylvania Department of Health

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 844700

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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