Use of EL-FIT App to Promote Physical Activity

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT04604860

Collaborator

American Association for the Study of Liver Diseases (AASLD) (Other), Pittsburgh Liver Research Center (Other)

Enrollment

Location

Arm

17.1

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Liver DIsease Cirrhosis, Liver	Behavioral: Fitness intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 23, 2020

Actual Primary Completion Date :

Feb 24, 2022

Actual Study Completion Date :

Feb 24, 2022

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Change in liver frailty index (LFI) score [12 weeks]
Change in liver frailty index from baseline to the end of the study
Change in six minute walk test (6MWT) [12 weeks]
Change in six minute walk test from baseline to the end of the study

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

University of Pittsburgh
American Association for the Study of Liver Diseases (AASLD)
Pittsburgh Liver Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andres Duarte-Rojo, Associate Professor, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT04604860

Other Study ID Numbers:

STUDY19020063

First Posted:

Oct 27, 2020

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

End Stage Liver Disease

Liver Cirrhosis

Study Results

No Results Posted as of Jun 7, 2022