End Stage Renal DiseaseNCT03189212
Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation
A study testing Telemedicine Visit in people with End Stage Renal Disease and Kidney Disease, Chronic, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- End Stage Renal Disease, Kidney Disease, Chronic
- What is being tested?
- Telemedicine Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 19 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving thrice-weekly hemodialysis treatment for 6 months
- On NYULMC kidney transplant wait list
Who cannot join
- Unable or unwilling to provide informed consent
- Unable to read or otherwise use an iPad (e.g. blind)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- End Stage Renal Disease, Kidney Disease, Chronic
- Being tested
- Usual Care Visit, Telemedicine Visit
- Keywords
- Telemedicine
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care VisitBehavioural
Routine 6-month follow up appointment at the NYULMC transplant center
Telemedicine VisitBehavioural
TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Visit | Active comparator | Not described Receives: Behavioral: Usual Care Visit |
| Telemedicine Visit | Experimental | Not described Receives: Behavioral: Telemedicine Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Oct 2017
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Ali, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189212
- Sponsor's protocol ID
- 16-02146
- Status last verified
- Jan 2023
- First submitted
- 31 May 2017
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation
- ClinicalTrials.gov ID
- NCT03189212
- Acronym / sponsor ID
- 16-02146
- Conditions
- End Stage Renal Disease, Kidney Disease, Chronic
- Keywords
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Visit | Active comparator | Behavioral: Usual Care Visit |
| Telemedicine Visit | Experimental | Behavioral: Telemedicine Visit |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving thrice-weekly hemodialysis treatment for 6 months
- On NYULMC kidney transplant wait list
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- Unable to read or otherwise use an iPad (e.g. blind)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care VisitRoutine 6-month follow up appointment at the NYULMC transplant center | Behavioural | Usual Care Visit |
| Telemedicine VisitTM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit | Behavioural | Telemedicine Visit |
Primary outcome
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Ali, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Visit in people with End Stage Renal Disease and Kidney Disease, Chronic, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waiting time (time frame: 4 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.