Virtual Interactive Platform (VIP) Transplant Research Study

The purpose of this study is to test a tablet-based application called VIP Transplant, devised to improve the recovery experience of patients that have recently had organ transplant surgery. The study will consist of two non-randomized arms: the first arm will consist of usual care and the second will be using the newly developed app for 21 days to replace their in-person visits. Using questionnaires and in-app usage metrics, the research team will track whether patients have a better medical outcome, greater patient satisfaction with care, and greater compliance rates as compared to patients who do not use VIP Transplant to manage their care.

Study Overview

• Status: Completed
• Conditions: Transplant Patients
• Intervention / Treatment: Device: Virtual Interactive Platform (VIP) Transplant

Detailed Description

An organ transplant requires a large time and financial investment for both the patient and provider over the course of a lifetime of follow-up visits and lifestyle monitoring. Patients return to the clinic 2-3 times a week for the first three months after surgery, and then visit the clinic twice a month with labs once a week 91-210 days post surgery. Check-ins for patients without complications occur 1-2 times a year, and these re-evaluations require patients to take time off work and travel to the transplant center often 2 hours away. Dr. David Mulligan, Chief of Transplant at Yale wanted to help patients reduce the time and cost associated with their regular checkups after surgery. Thus, we created VIP Transplant. The Virtual Interactive Platform allows patients to have a secure videoconference with their provider in order to eliminate the need for recurring travel and waiting in congested clinics for a short appointment. It will save patient time and cost to travel to the clinic. The application is integrated into the provider network in order to have a system that supports seamless communication between the patient and provider capabilities.

Research plan:

Dr. Mulligan will contact 8 of his patients who are willing to participate in the study. 4 of the patients will be assigned to the control group and the other 4 will be assigned to the experimental group.

Control group:

On day 1 after their surgery, patient will be asked to fill out a survey on their transplant care. On day 21, patient will be asked to fill out the same survey. The surgeon will be asked to take a survey to evaluate their each patient's progress.

Experimental group:

When the 4 patients attend orientation, patient will each be given the iPad with the VIP Transplant app and shown how to use the app. Patient will then be asked to fill out the survey on day 1 after their surgery and then asked to use VIP Transplant for their transplant care in the following days. Patient will then be asked to fill out the survey again on day 21, at the end of the study. The surgeon will be asked to take a survey to evaluate each of their patient's progress.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing to participate
• Familiarity with English
• Familiarity with iPad usage/technologically adept

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Only receive surveys.
Experimental: Experimental Group; Receive VIP Transplant App and surveys.	Device: Virtual Interactive Platform (VIP) Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to travel from home to Yale New Haven Hospital	Questionnaire, Scales of 1 to 10	30 days
Cost to travel from home to Yale New Haven Hospital	Questionnaire, Scales of 1 to 10	30 days
Patient Satisfaction with Care	Questionnaire, Scales of 1 to 10	30 days
Physician Satisfaction with Care	Questionnaire, Scales of 1 to 10	30 days

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2016
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1607018023