Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation

NCT ID: NCT03189212

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2021-01-19

Brief Summary

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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

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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.

Conditions

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End Stage Renal Disease Kidney Disease, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care Visit

Group Type ACTIVE_COMPARATOR

Usual Care Visit

Intervention Type BEHAVIORAL

Routine 6-month follow up appointment at the NYULMC transplant center

Telemedicine Visit

Group Type EXPERIMENTAL

Telemedicine Visit

Intervention Type BEHAVIORAL

TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit

Interventions

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Usual Care Visit

Routine 6-month follow up appointment at the NYULMC transplant center

Intervention Type BEHAVIORAL

Telemedicine Visit

TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Ali, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16-02146

Identifier Type: -

Identifier Source: org_study_id

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