Use of EL-FIT App to Promote Physical Activity

NCT ID: NCT04604860

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2022-02-24

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.

Conditions

End Stage Liver DIsease; Cirrhosis, Liver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EL-FIT

Patients using the EL-FIT app

Group Type: EXPERIMENTAL

Fitness intervention

Intervention Type: BEHAVIORAL

Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).

Interventions

Fitness intervention

Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Association for the Study of Liver Diseases (AASLD)

UNKNOWN

Sponsor Role: collaborator

Pittsburgh Liver Research Center

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Andres Duarte-Rojo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19020063

Identifier Type: -

Identifier Source: org_study_id