Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02828605
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2016-07-07
Brief Title:
Virtual Interactive Platform VIP Transplant Research Study
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Virtual Interactive Platform VIP Transplant Research Study
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 patients 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 patients progress
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 patients 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 patients progress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None