Health TrialsbyHealthPanel

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

ConditionsCirrhosis, LiverEnd Stage Liver DIseaseSymptoms and SignsPhysical InactivityMuscle Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

No access to a smartphone

Non-home dwelling

On hospice care

Model for end stage liver disease (MELD) score ≥30

Trial design

Design model

Parallel

Treatments tested in this trial

  • LiverWatch Intervention

    Behavioral

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Enhanced Usual CareNo intervention 0 interventions
Group B: LiverWatch InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 Weeks

Secondary outcomes

1

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.

Time frame
12 Weeks
2

Average Daily Step Count

The average daily step count will be measured in both groups longitudinally over 12 weeks using Fitbit.

Time frame
12 Weeks
3

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.

Time frame
12 Weeks
4

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.

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Pennsylvania Department of Health

Collaborator

Source ClinicalTrials.gov
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