Chronic Kidney DiseaseHC+PMNCT03354910
House Calls and Peer Mentorship
A study testing House Call and Peer Mentorship in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. 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?
- House Call and Peer Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2018to 18 Dec 2022
- 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
- Black race (including possible Cape Verdean, Haitian, Dominican)
- ≥18 yrs old
- English speaking
- Meets eligibility criteria for kidney transplant evaluation
- Ability to provide informed consent
- Resides within 1.5 hr drive of HC educator
Who cannot join
- Temporarily Unavailable (TU) on the waiting list and TU is likely to exceed 6 months based on judgement of kidney transplant team
- Awaiting combined kidney-liver transplantation
- Awaiting simultaneous pancreas-kidney transplantation
- Participation in another study to increase the likelihood of LDKT
- Prior participation in a transplant HC
- Prior or current participation in the NKF PM program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation
Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased donor organs, interventions expanding access to LDKT are needed, particularly for minority patients. House Calls (HC), an educational intervention developed by this study's PI has been shown to be an effective program for raising rates of live donation, especially for black patients. While the HC program has shown outstanding results, participant feedback suggested that follow-up may provide even more benefits. Previous research suggests that peer mentorship (PM) from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants. This study will examine the impact of the HC intervention combined with the peer mentorship program of the National Kidney Foundation on rates of live donor kidney transplantation.
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Being tested
- House Call, Peer Mentorship
- Keywords
- Live Donor Kidney Transplantation, LDKT, Disparity, African American, Education, Patient Support
- 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.
House CallBehavioural
60 to 90 minute home based educational intervention which will be administered by a health educator.
Peer MentorshipBehavioural
A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | All enrolled patients will receive Usual Care for transplant candidates at our two centers, which includes individual meetings with transplant providers, attendance at a patient group education session in the transplant center (focused on the specifics of the transplant experience), and a transplant education binder. |
| Usual Care (UC) + House Calls (HC) | Active comparator | Patients and their invited guests will be scheduled for one House Call. A house call is meeting done at a patient's home with transplant health educators facilitating a discussion on topics related to living kidney donation. Patients and guests also receive an information packet containing several brochures providing information about the living donation process, common concerns and misperceptions, and donation resources and information about our transplant center (e.g., copy of our quarterly newsletter, contact information). Patients in the group will also receive Usual Care, the regular education on living donation, provided as part of their routine transplant care. Receives: Behavioral: House Call |
| UC + HC + Peer Mentorship | Experimental | Patients in this condition will receive the Usual Care and the House Calls intervention as described previously. In addition, participants will receive access to a Peer Mentor trained by the National Kidney Foundation following their House Call. Receives: Behavioral: House Call; Behavioral: Peer Mentorship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live donor kidney transplants
The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year.
Measured: 1 Year Post-Intervention
Secondary outcomes (2)
Live donor evaluations
A secondary outcome for the study is the proportion of enrolled patients with a live donor evaluation at the one-year endpoint. A live donor evaluation is defined as the completion of a transplant evaluation to determine whether a potential living donor is eligible to donate.
Measured: 1 Year Post-Intervention
Live donor inquiries
A secondary outcome for the study is proportion of enrolled patients with live donor inquiries at the one-year endpoint. A live donor inquiry is when an individual contacts the transplant center to express interest in living donation, regardless of when they complete the entire live donor evaluation.
Measured: 1 Year Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start30 Apr 2018
- Primary completion31 Mar 2021
- Study completion18 Dec 2022
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.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Model description
- Treatment assignments will be based on a computer-generated randomization scheme, stratified by age (\<60 vs. ≥60 yrs old) and household income (\<250% vs. ≥250% of federal poverty guidelines), since older and low-income patients are known to have lower LDKT rates a priori. Patients will be randomized into one of three treatment arms in a 1:3:3 fashion such that 54 Usual Care, 160 HC and 160 HC+PM patients will be enrolled. The study investigators and research assistants conducting the study assessments of patients will remain blinded to the treatment assignments. KT candidates will be informed of group assignment immediately after completing the Baseline assessment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, James Rodrigue, Beth Israel Deaconess Medical Center
- Investigators
- James R Rodrigue, Ph.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354910
- Sponsor's protocol ID
- 2017P000521
- Other IDs
- PCORI 1609-36589
- Acronym
- HC+PM
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2017
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03354910
- Acronym / sponsor ID
- HC+PM / 2017P000521
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Keywords
- Live Donor Kidney Transplantation, LDKT, Disparity, African American, Education, Patient Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, Patient-Centered Outcomes Research Institute
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 28 Nov 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.
Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased donor organs, interventions expanding access to LDKT are needed, particularly for minority patients. House Calls (HC), an educational intervention developed by this study's PI has been shown to be an effective program for raising rates of live donation, especially for black patients. While the HC program has shown outstanding results, participant feedback suggested that follow-up may provide even more benefits. Previous research suggests that peer mentorship (PM) from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants. This study will examine the impact of the HC intervention combined with the peer mentorship program of the National Kidney Foundation on rates of live donor kidney transplantation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Treatment assignments will be based on a computer-generated randomization scheme, stratified by age (<60 vs. ≥60 yrs old) and household income (<250% vs. ≥250% of federal poverty guidelines), since older and low-income patients are known to have lower LDKT rates a priori. Patients will be randomized into one of three treatment arms in a 1:3:3 fashion such that 54 Usual Care, 160 HC and 160 HC+PM patients will be enrolled. The study investigators and research assistants conducting the study assessments of patients will remain blinded to the treatment assignments. KT candidates will be informed of group assignment immediately after completing the Baseline assessment.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –All enrolled patients will receive Usual Care for transplant candidates at our two centers, which includes individual meetings with transplant providers, attendance at a patient group education session in the transplant center (focused on the specifics of the transplant experience), and a transplant education binder. |
| Usual Care (UC) + House Calls (HC) | Active comparator | Behavioral: House CallPatients and their invited guests will be scheduled for one House Call. A house call is meeting done at a patient's home with transplant health educators facilitating a discussion on topics related to living kidney donation. Patients and guests also receive an information packet containing several brochures providing information about the living donation process, common concerns and misperceptions, and donation resources and information about our transplant center (e.g., copy of our quarterly newsletter, contact information). Patients in the group will also receive Usual Care, the regular education on living donation, provided as part of their routine transplant care. |
| UC + HC + Peer Mentorship | Experimental | Behavioral: House Call, Behavioral: Peer MentorshipPatients in this condition will receive the Usual Care and the House Calls intervention as described previously. In addition, participants will receive access to a Peer Mentor trained by the National Kidney Foundation following their House Call. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Black race (including possible Cape Verdean, Haitian, Dominican)
- ≥18 yrs old
- English speaking
- Meets eligibility criteria for kidney transplant evaluation
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Temporarily Unavailable (TU) on the waiting list and TU is likely to exceed 6 months based on judgement of kidney transplant team
- Awaiting combined kidney-liver transplantation
- Awaiting simultaneous pancreas-kidney transplantation
- Participation in another study to increase the likelihood of LDKT
- Prior participation in a transplant HC
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 |
|---|---|---|
| House Call60 to 90 minute home based educational intervention which will be administered by a health educator. | Behavioural | UC + HC + Peer Mentorship, Usual Care (UC) + House Calls (HC) |
| Peer MentorshipA National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants. | Behavioural | UC + HC + Peer Mentorship |
Primary outcome
Live donor kidney transplants
Time frame: 1 Year Post-Intervention
The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year.
2 secondary outcomes
Live donor evaluations
Time frame: 1 Year Post-Intervention
Live donor inquiries
Time frame: 1 Year Post-Intervention
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 18 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
James R Rodrigue, Ph.D. principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing House Call and Peer Mentorship in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Beth Israel Deaconess Medical Center at 2 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 6 inclusion and 6 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Live donor kidney transplants (time frame: 1 Year Post-Intervention). 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 18 Mar 2024.