Kidney TransplantNCT01981603
Transplant Navigator Dissemination
A study testing navigator in people with Kidney Transplant and Renal Failure Chronic Requiring Hemodialysis, run by Catherine Sullivan at 5 sites in United States.
Trial summary
Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant, Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,926 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2014to Dec 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18-70
- receiving in center hemodialysis
Who cannot join
- less than 18 years of age
- older than 70 years of age
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109
The Ohio State University
Columbus, Ohio
Lutheran Hospital
Fort Wayne, Indiana
University of Kentucky
Lexington, Kentucky
Jewish Hospital
Louisville, Kentucky
About this study
Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. In the control group, dialysis patients will continue to get usual care from their nephrologists and dialysis facility personnel.
Hypothesis: Compared to control patients, intervention patients will be significantly more likely to be wait listed or receive a kidney transplant.
- Being tested
- navigator
- Keywords
- Navigators, Kidney Transplant, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigatorOther
| Study group | Role | What they receive |
|---|---|---|
| navigator | Experimental | Kidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process. Receives: Other: navigator |
| usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who are wait listed or receive a kidney transplant.
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study start1 Jan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Sullivan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Sullivan, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981603
- Sponsor's protocol ID
- IRB12-00660
- Status last verified
- Mar 2018
- First submitted
- 30 Oct 2013
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplant Navigator Dissemination
- ClinicalTrials.gov ID
- NCT01981603
- Acronym / sponsor ID
- IRB12-00660
- Keywords
- Navigators, Kidney Transplant, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,926 participants (actual)
- Lead sponsor
- Catherine SullivanUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Nov 2013 (estimated)
- 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.
Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. In the control group, dialysis patients will continue to get usual care from their nephrologists and dialysis facility personnel.
Hypothesis: Compared to control patients, intervention patients will be significantly more likely to be wait listed or receive a kidney transplant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navigator | Experimental | Other: navigatorKidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process. |
| usual care | No intervention | –usual care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between the ages of 18-70
- receiving in center hemodialysis
Key exclusion criteria (2 listed)
- less than 18 years of age
- older than 70 years of age
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 |
|---|---|---|
| navigator | Other | navigator |
Primary outcome
The proportion of patients who are wait listed or receive a kidney transplant.
Time frame: approximately 3 years
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 22 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigator in people with Kidney Transplant and Renal Failure Chronic Requiring Hemodialysis, run by Catherine Sullivan at 5 sites 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The proportion of patients who are wait listed or receive a kidney transplant. (time frame: approximately 3 years). 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 22 Mar 2018.