Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

January 10, 2023 updated by: NYU Langone Health
The purpose of this study is to determine whether a telemedicine follow-up visit at the NYU Langone Transplant Institute is a feasible and acceptable alternative to a traditional in-center follow-up visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A six-month prospective randomized-controlled clinical pilot study to evaluate a new intervention for the transplant program: telemedicine (TM) visits. Researchers will target patients on the transplant waiting list who are currently undergoing dialysis. Currently, there are 234 patients on the transplant waiting list who receiving care at dialysis centers in the New York City area. Researchers will select the 10 dialysis centers having the highest number of patients on the transplant list in order to yield a target sample of 45.

Eligible participants will be randomized to 1 of 2 groups: (1) usual care (UC) which is the routine 6-month follow up appointment at the NYULMC transplant center or (2) TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit. Patients will be followed for 4 months post randomization to determine the number of days that elapse between randomization and routine transplant evaluation. As new clinic appointments are currently experiencing 80-day wait, a 4-month follow-up should be more than adequate to evaluate this primary outcome.

The intervention will be evaluated primarily in terms of efficiency, and secondarily in terms of patient/physician experiences, changes in waiting list status, and referral for living donation.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Receiving thrice-weekly hemodialysis treatment for 6 months
  • On NYULMC kidney transplant wait list

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Unable to read or otherwise use an iPad (e.g. blind)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care Visit
Behavioral: Usual Care Visit
Routine 6-month follow up appointment at the NYULMC transplant center
Experimental: Telemedicine Visit
Behavioral: Telemedicine Visit
TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waiting time
Time Frame: 4 Months
The study is powered to evaluate wait time for the next transplant clinic appointment, abstracted from the patient's electronic record at the conclusion of the study.
4 Months
Missed visits
Time Frame: 4 Months
Using the medical record, researchers will capture the frequency of no-shows, cancellations, and rescheduled visits. At the 4-month time point, researchers will interview patients to collect qualitative data regarding the reasons for missed or rescheduled appointments. They will also collect data regarding the frequency with which TM visits result in transplant coordinator requests for an additional in-person appointment in order to conduct a physical assessment.
4 Months
Cost
Time Frame: 4 Months
Researchers will estimate cost of UC and TM in terms of costs borne by the patient (transportation, childcare, missed employment time, missed leisure) using an investigator-developed instrument. They will estimate health care service delivery costs using standard accounting methods to estimate facility costs, wage and fringe rates for staff involved in care (including receptionist, nurse, TM staff), and technology costs (including the iPads, data plans, maintenance and replacement costs).
4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Nicole Ali, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

January 19, 2021

Study Completion (Actual)

January 19, 2021

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-02146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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