Use of EL-FIT App to Promote Physical Activity (EL-FIT)

EL-FIT (Exercise and Liver FITness): Validation of an Innovative Virtual Tool to Promote Physical Activity in Liver Transplant Candidates With Advanced Liver Disease

Transplant-eligible patients with cirrhosis and ESLD, age 40-70, MELD >/= 10 referred to transplant physical therapy will be invited to participate. The investigators will exclude those who lack a smartphone or the understanding of its functionality, lack home wireless internet, or have recurrent/persistent overt hepatic encephalopathy. Following signing of informed consent, each participant will be given a Fitbit Charge 3 and have EL-FIT and Fitbit apps downloaded to their smartphone. After a brief session with a member of the research team explaining the basic components and functionality of EL-FIT and Fitbit, patients will be provided with general physical activity recommendations (as per our current standard of care) and asked to explore all features of EL-FIT and Fitbit apps, up until their 12-week follow-up visit. Phone calls to incentivize physical activity and exercise will be performed by members of the research team.

Study Overview

• Status: Completed
• Conditions: Cirrhosis, Liver; End Stage Liver DIsease
• Intervention / Treatment: Behavioral: Fitness intervention

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• cirrhosis and ESLD
• transplant eligible
• MELD >/=10
• referred to transplant physical therapist

Exclusion Criteria:

• those who lack a smartphone or the understanding of its functionality
• lack home wireless internet
• have recurrent/persistent overt hepatic encephalopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EL-FIT; Patients using the EL-FIT app	Behavioral: Fitness intervention; Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in liver frailty index (LFI) score	Change in liver frailty index from baseline to the end of the study	12 weeks
Change in six minute walk test (6MWT)	Change in six minute walk test from baseline to the end of the study	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily average steps	Comparison of average daily steps from baseline until the end of study	12 weeks
Usability of EL-FIT app	How patient interacts with each of the features of EL-FIT app based on responses to questionairre	12 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: American Association for the Study of Liver Diseases (AASLD); Pittsburgh Liver Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2020
• Primary Completion (ACTUAL): February 24, 2022
• Study Completion (ACTUAL): February 24, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (ACTUAL): October 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Fibrosis; Liver Diseases; End Stage Liver Disease; Liver Cirrhosis
• Other Study ID Numbers: STUDY19020063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No