Cirrhosis, LiverNCT06136221
Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
A study testing LiverWatch Intervention in people with Cirrhosis, Liver and End Stage Liver DIsease, run by University of Pennsylvania at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, End Stage Liver DIsease, Symptoms and Signs
- What is being tested?
- LiverWatch Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Deemed not appropriate by treating physician for medical reasons
- Enrolled in other dietary or physical activity interventions
- Receiving physical therapy as standard of care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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
- Being tested
- LiverWatch Intervention
- Keywords
- Telehealth, Remote Symptom Monitoring, Gamification
- Medical subject headings
- Liver Cirrhosis, End Stage Liver Disease, Signs and Symptoms, Sedentary Behavior, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverWatch InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No 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. |
| LiverWatch Intervention | Experimental | 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. Receives: Behavioral: LiverWatch Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS 29+2
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.
Measured: 12 Weeks
Secondary outcomes (8)
Automated Self-Administered 24-hour Dietary Assessment Tool
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.
Measured: 12 Weeks
Average Daily Step Count
The average daily step count will be measured in both groups longitudinally over 12 weeks using Fitbit.
Measured: 12 Weeks
MoCA for the Blind
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.
Measured: 12 Weeks
Simplified Animal Naming Test (S-ANT)
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.
Measured: 12 Weeks
Grip Strength
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.
Measured: 12 Weeks
Balance
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.
Measured: 12 Weeks
30-Second Chair Test
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.
Measured: 12 Weeks
Days Alive and Out of Hospital (DAOH)
The number of days a patient spends alive and not hospitalized for any reason.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a longitudinal intervention study utilizing diverse cohorts of patients with cirrhosis. It is a 2-arm, patient-randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136221
- Sponsor's protocol ID
- 844700
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
- ClinicalTrials.gov ID
- NCT06136221
- Acronym / sponsor ID
- 844700
- Conditions
- Cirrhosis, Liver, End Stage Liver DIsease, Symptoms and Signs, Physical Inactivity, Muscle Loss
- Keywords
- Telehealth, Remote Symptom Monitoring, Gamification
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a longitudinal intervention study utilizing diverse cohorts of patients with cirrhosis. It is a 2-arm, patient-randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | No 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. |
| LiverWatch Intervention | Experimental | Behavioral: LiverWatch InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiverWatch InterventionThe 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. | Behavioural | LiverWatch Intervention |
Primary outcome
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.
8 secondary outcomes
Automated Self-Administered 24-hour Dietary Assessment Tool
Time frame: 12 Weeks
Average Daily Step Count
Time frame: 12 Weeks
MoCA for the Blind
Time frame: 12 Weeks
Simplified Animal Naming Test (S-ANT)
Time frame: 12 Weeks
Grip Strength
Time frame: 12 Weeks
Balance
Time frame: 12 Weeks
30-Second Chair Test
Time frame: 12 Weeks
Days Alive and Out of Hospital (DAOH)
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiverWatch Intervention in people with Cirrhosis, Liver and End Stage Liver DIsease, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS 29+2 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.