Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cirrhosis, Liver
  • End Stage Liver Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 70 years
Gender
Both males and females

Description

The study consists of two visits, baseline and 12-week follow-up, with at least one follow-up phone call on a weekly basis. Visit one is expected to last for 30 minutes and visit 2 for 60 minutes, whereas each phone call should take no more than 15 minutes. Twice during the study period, the investi...

The study consists of two visits, baseline and 12-week follow-up, with at least one follow-up phone call on a weekly basis. Visit one is expected to last for 30 minutes and visit 2 for 60 minutes, whereas each phone call should take no more than 15 minutes. Twice during the study period, the investigators will draw serum and plasma samples for future translational research. Daily, the physical trainer will review collected data on EL-FIT research database and Fitabase. Each participant will have an exit interview by the end of week 12 with the trainer and a member of the research team to talk about their impressions of using EL-FIT and Fitbit, through a structured questionnaire assessing about how user friendly it was to use the EL-FIT app. Finally, trainers will be asked to compare the type of prescription that they provided to patients as part of the standard of care (based on liver frailty index or 6-minute walk test), to compare it with the allocation provided by EL-FIT stratification algorithm. To learn about how to improve EL-FIT the investigators will ask patients and their caregivers open-ended questions as part of their exit interview. This will allow us to identify barriers precluding them from keeping up with physical trainer recommendations, and what would they like to include to enhance motivation as part of a physical activity program. A member of the research team will act as a facilitator during this session.

Tracking Information

NCT #
NCT04604860
Collaborators
  • American Association for the Study of Liver Diseases (AASLD)
  • Pittsburgh Liver Research Center
Investigators
Not Provided