NCT03189212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2021

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

3.3 years

First QC Date

May 31, 2017

Last Update Submit

January 10, 2023

Conditions

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (3)

  • 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.

    4 Months

  • 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.

    4 Months

  • 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).

    4 Months

Study Arms (2)

Usual Care Visit

ACTIVE COMPARATOR
Behavioral: Usual Care Visit

Telemedicine Visit

EXPERIMENTAL
Behavioral: Telemedicine Visit

Interventions

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

Usual Care Visit

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

Telemedicine Visit

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Ali, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 16, 2017

Study Start

October 1, 2017

Primary Completion

January 19, 2021

Study Completion

January 19, 2021

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations