Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136221
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-10-30
Brief Title:
Testing LiverWatch a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Testing LiverWatch a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eg 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 n55 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
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 n55 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None