Chronic Kidney DiseaseNCT02319447
Increasing Kidney Transplant Among Blacks on the Transplant Waiting List
A study testing Additional education in people with Chronic Kidney Disease and End-Stage Renal Disease, run by St. Barnabas Medical Center at 1 site in United States.
Trial summary
For most patients with kidney failure, living donor kidney transplant (LDKT) is their best treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney failure but less likely to receive LDKTs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Disease, End-Stage Renal Disease
- What is being tested?
- Additional education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Aug 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-reported as Black or African-American
- 21 years of age or older
- active on kidney transplant waiting list at Saint Barnabas Medical Center
Who cannot join
- limited English proficiency
- unable or unwilling to provide informed consent
- unable to complete in-person and telephone questionnaires (including hearing impairment or low vision)
- lack a working telephone
- live 150 miles or greater from transplant center
- enrolled in prior randomized intervention trial, NCT01261910, at our center
- currently already scheduled to receive a live donor kidney transplant
- active on the simultaneous pancreas-kidney transplant waiting list
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
About this study
For most patients with kidney failure, living donor kidney transplant (LDKT) is their best treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney failure but less likely to receive LDKTs. In this study, the investigators will test an intervention designed to address this disparity, by performing a parallel group, two-arm randomized clinical trial among 500 Black kidney transplant candidates. The main objective of this study is to test an educational and behavioral intervention that is designed to increase receipt of LDKT among transplant candidates (persons active on the deceased donor kidney transplant waiting list) who are Black. Our overall hypothesis is that a multi-component intervention administered to Black transplant candidates will increase both readiness to pursue LDKT and actual receipt of LDKTs. The investigators will randomly assign kidney transplant candidates on the kidney transplant waiting list to either: (1) a control group that will receive Usual Care, or (2) an Intervention group that will receive a group-based intervention, as well as monthly mailings and a follow-up phone call by a transplant educator.
Read the detailed description
The best treatment for severe chronic kidney disease is usually a living donor kidney transplant (LDKT), but large racial disparities persist in receipt of LDKTs. In 2011, Blacks, who comprised 36.8% of the dialysis population, received 32.2% of deceased donor kidney transplants (DDKTs) but just 14.0% of LDKTs. Among kidney transplant candidates who are Black, their lower rate of LDKT largely stems from a lack of donor volunteers (persons interested in donating a living kidney to them). The most effective ways to motivate and help Black transplant candidates to "recruit" or identify any (or more) donor volunteers remain unclear. Several interventions appear promising and are being tested, but none has proven both practical and effective.
Transplant candidates, particularly those who are Black, report that multiple barriers prevent them from receiving LDKTs. These barriers include minimal knowledge about LDKT; fears about donors' future health; guilt; medical mistrust; and discomfort about how to discuss LDKT with family and friends. Most transplant candidates have never met either a kidney donor or a recipient of a transplant or LDKT. A multi-component intervention that efficiently addresses these barriers could plausibly increase receipt of LDKT among Blacks.
The main objective of this study is to test an educational and behavioral intervention that is designed to increase receipt of LDKT among transplant candidates (persons active on the DDKT waiting list) who are Black. Our overall hypothesis is that a multi-component intervention administered to Black transplant candidates will increase both readiness to pursue LDKT and actual receipt of LDKTs.
To meet this objective and test our hypothesis, we propose a two-arm, parallel group randomized trial among 500 Black kidney transplant candidates. After Black transplant candidates are placed on the waiting list for a DDKT, we will randomize them to either: (1) a control group that will receive Usual Care, or (2) an Intervention group that will receive a group-based intervention as well as monthly mailings and a follow-up phone call by a transplant educator. Participants randomized to the Intervention will be asked to attend, in small groups with any family and friends, a 60-90 minute seminar that will feature brief talks regarding: ●basic facts about CKD, transplant, and the waiting list; ●the experience of receiving a LDKT transplant (by a Black LDKT recipient); ●the experience of serving as a living kidney donor (by a Black living kidney donor); and ●strategies to increase the chances of getting a transplant sooner.
Our Specific Aims are as follows:
Aim 1 (Primary Aim): To compare readiness to pursue LDKT and receipt of LDKT in the Intervention vs. Usual Care groups of our randomized clinical trial, during the 18 months after randomization
Hypothesis: Exposure to the multi-component Intervention is associated with an increase in readiness to pursue LDKT and an increase in receipt of LDKT
Aim 2: To determine the baseline social and behavioral variables that modify the effect of the Intervention upon readiness to pursue LDKT and actual receipt of LDKT
Hypothesis: Greater knowledge of LDKT and greater readiness to pursue LDKT are associated with receipt of LDKT
Aim 3: To determine whether changes in social and behavioral variables mediate the effects of the Intervention upon readiness to pursue LDKT and actual receipt of LDKT
Hypothesis: Increases in readiness to pursue LDKT are associated with receipt of LDKT
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Being tested
- Additional education
- Keywords
- Living Donation, Kidney Transplantation
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional educationBehavioural
Our Intervention includes a 60-90 minute educational seminar, entitled "Destination: Transplant", featuring "live" speakers, delivered to small groups of Black kidney transplant candidates and their family and friends. Topics include: 1) basic facts about Chronic Kidney Disease (CKD), transplant, and the waiting list; 2) the experience of receiving a LDKT transplant (by a Black LDKT recipient); 3) the experience of serving as a living kidney donor (by a Black living kidney donor); and 4) strategies to increase the chances of getting a transplant sooner. Participants receive monthly mailed, written information for 9 months and a follow-up phone call from a transplant educator, 3 months after attending the seminar.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | After randomization, these study participants will receive the Usual Care received by all listed kidney transplant candidates at our center. |
| Additional education | Experimental | These study participants will be invited to attend a 60-90 minute educational seminar, entitled Destination: Transplant, delivered in a group setting. They will also receive monthly mailings for 9 months and a follow-up phone call from a transplant educator. Receives: Behavioral: Additional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in readiness to pursue LDKT at 9 months
Our primary outcome is the proportion of study participants with an increase in their readiness to pursue LDKT. Readiness to pursue LDKT is assessed by the patient's Stage of Change regarding pursuing live donation, based upon James Prochaska's Transtheoretical Model. The Stages of Change regarding pursuit of living donation include: not considering (Pre-contemplation), considering (Contemplation), preparing to pursue (Preparation), or taking action to pursue (Action) living donation within the next 6 months. Stage of Change will be assessed at baseline and at 9 months post-baseline.
Measured: Baseline, 9 months
Secondary outcomes (4)
Receipt of a LDKT
Among trial participants, we will determine whether or not they received a LDKT in the United States during the 18 months after they were enrolled in the trial and randomized. This determination will be made by examining each study participant's medical records.
Measured: 18 months
Number of donor volunteers recruited and evaluated
We will examine each study participant's medical records to determine how many living donor volunteers contacted the transplant center to donate and how many donor volunteers were evaluated by the transplant center, during the 18 month follow-up period.
Measured: 18 months
Status on kidney transplant waiting list
After 18 months of follow-up, for study participants who remain on the waiting list, we will determine whether they are: ●active (Status 1), or ●inactive (Status 7) on the waiting list. Other patients will have been removed from the Saint Barnabas Medical Center (SBMC) waiting list because they: ●died; ●became too sick to transplant; ●refused transplant; ●transferred to another center; ●improved and no longer required transplant; ●received a DDKT; ●received a LDKT; or ●other. We will determine these reasons, along with the date they occurred, by examining the medical records for each patient.
Measured: 18 months
Change in knowledge of LDKT at 9 months
We will assess knowledge of transplant and LDKT at baseline and 9 months, using a questionnaire containing multiple-choice and true-false questions.
Measured: Baseline, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Barnabas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Rutgers University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Francis L Weng, MD, MSCE, Principal investigator, St. Barnabas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319447
- Sponsor's protocol ID
- SBMC 2012-69
- Other IDs
- R01DK098744
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2014
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Kidney Transplant Among Blacks on the Transplant Waiting List
- ClinicalTrials.gov ID
- NCT02319447
- Acronym / sponsor ID
- SBMC 2012-69
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Keywords
- Living Donation, Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- St. Barnabas Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Rutgers University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Dec 2014 (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.
For most patients with kidney failure, living donor kidney transplant (LDKT) is their best treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney failure but less likely to receive LDKTs. In this study, the investigators will test an intervention designed to address this disparity, by performing a parallel group, two-arm randomized clinical trial among 500 Black kidney transplant candidates. The main objective of this study is to test an educational and behavioral intervention that is designed to increase receipt of LDKT among transplant candidates (persons active on the deceased donor kidney transplant waiting list) who are Black. Our overall hypothesis is that a multi-component intervention administered to Black transplant candidates will increase both readiness to pursue LDKT and actual receipt of LDKTs. The investigators will randomly assign kidney transplant candidates on the kidney transplant waiting list to either: (1) a control group that will receive Usual Care, or (2) an Intervention group that will receive a group-based intervention, as well as monthly mailings and a follow-up phone call by a transplant educator.
Detailed description
The best treatment for severe chronic kidney disease is usually a living donor kidney transplant (LDKT), but large racial disparities persist in receipt of LDKTs. In 2011, Blacks, who comprised 36.8% of the dialysis population, received 32.2% of deceased donor kidney transplants (DDKTs) but just 14.0% of LDKTs. Among kidney transplant candidates who are Black, their lower rate of LDKT largely stems from a lack of donor volunteers (persons interested in donating a living kidney to them). The most effective ways to motivate and help Black transplant candidates to "recruit" or identify any (or more) donor volunteers remain unclear. Several interventions appear promising and are being tested, but none has proven both practical and effective.
Transplant candidates, particularly those who are Black, report that multiple barriers prevent them from receiving LDKTs. These barriers include minimal knowledge about LDKT; fears about donors' future health; guilt; medical mistrust; and discomfort about how to discuss LDKT with family and friends. Most transplant candidates have never met either a kidney donor or a recipient of a transplant or LDKT. A multi-component intervention that efficiently addresses these barriers could plausibly increase receipt of LDKT among Blacks.
The main objective of this study is to test an educational and behavioral intervention that is designed to increase receipt of LDKT among transplant candidates (persons active on the DDKT waiting list) who are Black. Our overall hypothesis is that a multi-component intervention administered to Black transplant candidates will increase both readiness to pursue LDKT and actual receipt of LDKTs.
To meet this objective and test our hypothesis, we propose a two-arm, parallel group randomized trial among 500 Black kidney transplant candidates. After Black transplant candidates are placed on the waiting list for a DDKT, we will randomize them to either: (1) a control group that will receive Usual Care, or (2) an Intervention group that will receive a group-based intervention as well as monthly mailings and a follow-up phone call by a transplant educator. Participants randomized to the Intervention will be asked to attend, in small groups with any family and friends, a 60-90 minute seminar that will feature brief talks regarding: ●basic facts about CKD, transplant, and the waiting list; ●the experience of receiving a LDKT transplant (by a Black LDKT recipient); ●the experience of serving as a living kidney donor (by a Black living kidney donor); and ●strategies to increase the chances of getting a transplant sooner.
Our Specific Aims are as follows:
Aim 1 (Primary Aim): To compare readiness to pursue LDKT and receipt of LDKT in the Intervention vs. Usual Care groups of our randomized clinical trial, during the 18 months after randomization
Hypothesis: Exposure to the multi-component Intervention is associated with an increase in readiness to pursue LDKT and an increase in receipt of LDKT
Aim 2: To determine the baseline social and behavioral variables that modify the effect of the Intervention upon readiness to pursue LDKT and actual receipt of LDKT
Hypothesis: Greater knowledge of LDKT and greater readiness to pursue LDKT are associated with receipt of LDKT
Aim 3: To determine whether changes in social and behavioral variables mediate the effects of the Intervention upon readiness to pursue LDKT and actual receipt of LDKT
Hypothesis: Increases in readiness to pursue LDKT are associated with receipt of LDKT
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –After randomization, these study participants will receive the Usual Care received by all listed kidney transplant candidates at our center. |
| Additional education | Experimental | Behavioral: Additional educationThese study participants will be invited to attend a 60-90 minute educational seminar, entitled Destination: Transplant, delivered in a group setting. They will also receive monthly mailings for 9 months and a follow-up phone call from a transplant educator. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- self-reported as Black or African-American
- 21 years of age or older
- active on kidney transplant waiting list at Saint Barnabas Medical Center
Key exclusion criteria (8 listed)
- limited English proficiency
- unable or unwilling to provide informed consent
- unable to complete in-person and telephone questionnaires (including hearing impairment or low vision)
- lack a working telephone
- live 150 miles or greater from transplant center
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 |
|---|---|---|
| Additional educationOur Intervention includes a 60-90 minute educational seminar, entitled "Destination: Transplant", featuring "live" speakers, delivered to small groups of Black kidney transplant candidates and their family and friends. Topics include: 1) basic facts about Chronic Kidney Disease (CKD), transplant, and the waiting list; 2) the experience of receiving a LDKT transplant (by a Black LDKT recipient); 3) the experience of serving as a living kidney donor (by a Black living kidney donor); and 4) strategies to increase the chances of getting a transplant sooner. Participants receive monthly mailed, written information for 9 months and a follow-up phone call from a transplant educator, 3 months after attending the seminar. | Behavioural | Additional education |
Primary outcome
Change in readiness to pursue LDKT at 9 months
Time frame: Baseline, 9 months
Our primary outcome is the proportion of study participants with an increase in their readiness to pursue LDKT. Readiness to pursue LDKT is assessed by the patient's Stage of Change regarding pursuing live donation, based upon James Prochaska's Transtheoretical Model. The Stages of Change regarding pursuit of living donation include: not considering (Pre-contemplation), considering (Contemplation), preparing to pursue (Preparation), or taking action to pursue (Action) living donation within the next 6 months. Stage of Change will be assessed at baseline and at 9 months post-baseline.
4 secondary outcomes
Receipt of a LDKT
Time frame: 18 months
Number of donor volunteers recruited and evaluated
Time frame: 18 months
Status on kidney transplant waiting list
Time frame: 18 months
Change in knowledge of LDKT at 9 months
Time frame: Baseline, 9 months
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 27 Dec 2019.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data.
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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.
Francis L Weng, MD, MSCE principal investigator
St. Barnabas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional education in people with Chronic Kidney Disease and End-Stage Renal Disease, run by St. Barnabas Medical Center 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 3 inclusion and 8 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 27 Dec 2019. 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?
Change in readiness to pursue LDKT at 9 months (time frame: Baseline, 9 months). 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 27 Dec 2019.