Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation

NCT ID: NCT03584646

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2022-10-01

Brief Summary

This is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the PRIMER intervention in improving physical function and reducing frailty in adult Liver Transplant candidates. The intervention will consist of a patient-tailored prehabilitation program designed to reduce frailty, improve physical function and nutritional status, and optimize pre- and post-transplant outcomes.

Detailed Description

The investigator will pilot-test a two-arm, randomized trial of a prehabilitation intervention in 38 pre-liver transplant patients with End Stage Liver Disease (ESLD). The investigator estimates an attrition rate of 20%, resulting n=30 participants; 10 participants in Arm 1 (control arm) and 20 participants in Arm 2 (intervention arm). To be eligible, patients must be waitlisted or "Penn-Ready" with a MELD-Na less than or equal to 25, English-speaking, able to safely participant in an exercise program, have a smartphone, and be identified as frail. The purpose of this trial is to develop and implement a program of medical optimization, physical activity, and nutrition recommendations specifically tailored to ESLD and designed to reduce frailty, improve physical function, and optimize pre- and post-transplant outcomes.

Conditions

Liver Diseases; End Stage Liver Disease; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1 - Control Arm

Usual care, nutrition and exercise counseling at baseline, use of the Nokia GO wearable step tracker device and end-of-study assessment at the end of the 14-week study period. Participants will receive the Nokia GO wearable step tracker to monitor daily step counts, but they will not be provided with personalized walking goals or automated feedback on goal attainment via text message.

Group Type: EXPERIMENTAL

Nokia GO Wearable StepTracker

Intervention Type: DEVICE

All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.

Arm 2 - Intervention arm

Physical activity program supported by financial incentives for meeting walking goals and participating in weekly check-in appointments with study team members via telephone calls. Participants in the intervention arm will also receive twice-daily medication reminders via bidirectional text messages to promote medication adherence. Participants in Arm 2 will also receive personalized nutrition and exercise counseling, daily feedback on step counts via the Nokia GO wearable step tracker and their smartphones, and an end-of-study assessment.

Group Type: EXPERIMENTAL

Nokia GO Wearable StepTracker

Intervention Type: DEVICE

All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.

Medication Reminder

Intervention Type: OTHER

Medication reminders are sent to participants in Arm 2 on a daily basis.

Weekly Check-in appointment with study team or provider

Intervention Type: OTHER

Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.

Interventions

Nokia GO Wearable StepTracker

All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.

Intervention Type: DEVICE

Medication Reminder

Medication reminders are sent to participants in Arm 2 on a daily basis.

Intervention Type: OTHER

Weekly Check-in appointment with study team or provider

Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participants must be wait-listed, in transplant evaluation, or "Penn Ready" with a MELD-Na score less than or equal to 25;

2. Patients must be English speaking and own/use a smartphone and cognitively able to consent;

3. Patient and physician feel that individual can safely participate in an exercise program;

4. Meeting at least one 'at risk' criterion for impaired physical performance, frailty, or malnutrition (by SPPB, abPG-SG, dynamometer measured grip strength), or physical deconditioning as determined by physical therapist, or treating clinician.

Exclusion Criteria

1. The patient is unable to provide informed consent;

2. The patient has been hospitalized within the last 30 days;

3. A score of 0-3 points on the SPPB assessment indicating inability to participate in a physical activity program or a score of 12 in the absence of frailty or malnutrition (indicating low risk for poor physical or performance or malnutrition);

4. The patient is at risk for falling as defined by clinician assessment results or if the patient states that he/she has a history of falling (record of a fall(s) in the past 30 days);

5. The patient is already enrolled in a financial incentive-based exercise program using a wearable device;

6. Any other medical conditions that would prohibit participation in a physical activity program as determined by transplant clinicians or severe vision, hearing, or mobility impairment precluding participation.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Marina Serper, MD, MS

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

828669

Identifier Type: -

Identifier Source: org_study_id