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Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

Primary Purpose

End Stage Renal Disease, Kidney Disease, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care Visit
Telemedicine Visit
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease focused on measuring Telemedicine

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care Visit

Telemedicine Visit

Arm Description

Outcomes

Primary Outcome Measures

Waiting time
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.
Missed visits
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.
Cost
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).

Secondary Outcome Measures

Full Information

First Posted
May 31, 2017
Last Updated
January 10, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03189212
Brief Title
Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation
Official Title
Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
January 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Kidney Disease, Chronic
Keywords
Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Visit
Arm Type
Active Comparator
Arm Title
Telemedicine Visit
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Visit
Intervention Description
Routine 6-month follow up appointment at the NYULMC transplant center
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine Visit
Intervention Description
TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit
Primary Outcome Measure Information:
Title
Waiting time
Description
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.
Time Frame
4 Months
Title
Missed visits
Description
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.
Time Frame
4 Months
Title
Cost
Description
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).
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Ali, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

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