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

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136221
• Other study ID #: 844700
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Richard Mason, PharmD
• Phone: 215-662-3904
• Email: richard.mason[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	Average Daily Step Count	The average daily step count will be measured in both groups longitudinally over 12 weeks using Fitbit.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	Days Alive and Out of Hospital (DAOH)	The number of days a patient spends alive and not hospitalized for any reason.	24 Weeks