Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06136221 |
Other study ID # |
844700 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.