Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LiverWatch Intervention.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver, End Stage Liver DIsease, Symptoms and Signs, Physical Inactivity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- PROMIS 29+2 [Time frame: 12 Weeks]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- University of Michigan — Ann Arbor
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06136221 · 844700