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

Primary Purpose

End Stage Liver DIsease, Cirrhosis, Liver

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitness intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Liver DIsease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EL-FIT

Arm Description

Patients using the EL-FIT app

Outcomes

Primary Outcome Measures

Change in liver frailty index (LFI) score
Change in liver frailty index from baseline to the end of the study
Change in six minute walk test (6MWT)
Change in six minute walk test from baseline to the end of the study

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2020
Last Updated
June 3, 2022
Sponsor
University of Pittsburgh
Collaborators
American Association for the Study of Liver Diseases (AASLD), Pittsburgh Liver Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04604860
Brief Title
Use of EL-FIT App to Promote Physical Activity
Acronym
EL-FIT
Official Title
EL-FIT (Exercise and Liver FITness): Validation of an Innovative Virtual Tool to Promote Physical Activity in Liver Transplant Candidates With Advanced Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
American Association for the Study of Liver Diseases (AASLD), Pittsburgh Liver Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver DIsease, Cirrhosis, Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EL-FIT
Arm Type
Experimental
Arm Description
Patients using the EL-FIT app
Intervention Type
Behavioral
Intervention Name(s)
Fitness intervention
Intervention Description
Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).
Primary Outcome Measure Information:
Title
Change in liver frailty index (LFI) score
Description
Change in liver frailty index from baseline to the end of the study
Time Frame
12 weeks
Title
Change in six minute walk test (6MWT)
Description
Change in six minute walk test from baseline to the end of the study
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in daily average steps
Description
Comparison of average daily steps from baseline until the end of study
Time Frame
12 weeks
Title
Usability of EL-FIT app
Description
How patient interacts with each of the features of EL-FIT app based on responses to questionairre
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of EL-FIT App to Promote Physical Activity

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