House Calls and Peer Mentorship

Chronic Kidney Disease Clinical Trial

— HC+PM  

Official title:

Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354910
• Other study ID #: 2017P000521
• Secondary ID: PCORI 1609-36589
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: December 18, 2022

Study information

• Verified date: March 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 18, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• House Call
60 to 90 minute home based educational intervention which will be administered by a health educator.
• Peer Mentorship
A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Medical University of South Carolina, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in live donor kidney transplant knowledge measured through Living Donation Kidney Transplant Knowledge (LDKT-K) scale score	An improvement in patient knowledge is measured by the change in score of a scored instrument, the Living Donation Kidney Transplant Knowledge Scale (LDKT-K). The LDKT-K is a scored true or false questionnaire that tests patient's knowledge on living donation. A higher score indicates that a participant answered more questions correctly.	Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Other	Improvement in live donor kidney transplant readiness measured through Living Donation Kidney Transplant Readiness scale (LDKT-R) score	Improvement in patient readiness to pursue LDKT is measured by a scored instrument, the Living Donation Kidney Transplant Readiness Scale (LDKT-R). The LDKT-R is a 5-point scale where patient's self report their readiness to pursue living donation and where in the process they are (i.e., they are beginning to think about living donation, have spoken with potential donors, etc.) A higher score on this assessment indicates greater readiness to pursue LDKT.	Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Other	Reduced health care mistrust measured through Health Care Distrust Scale (HCDS) score	Reduction in patient mistrust towards the health care system is measured through a scale, the Health Care Distrust Scale (HCDS). This scale is a 5-point Likert scale that measures the degree of agreement patients have on statements regarding their trust of the medical system. For example, one such statement reads "the health care systems lie to make money." A higher score on this assessment indicates higher levels of mistrust of the health care system.	Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Other	Reduced live donor kidney transplant concerns measured through measured Living Donation Kidney Transplant Concerns scale (LDKT-C) score	Patient's concerns towards LDKT is measured using a 5-point scale, the Living Donation Kidney Transplant Concerns scale (LDKT-C) where patients indicate their level of concern towards common concerns patients have regarding living donation. A higher score on this assessment indicates higher levels of concern towards living donation.	Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Other	Greater amount of time spent discussing LDKT and higher quality interactions measured through the Talking About Living Donation (TaLKeD) instrument	The time patients speak with others about LDKT and whether these interactions are of higher quality compared to pre-intervention is measured through a self-report instrument, Talking About Living Donation (TaLKeD), that asks the cumulative time patient's spoke with others (family, friends, etc.) about living donation and their perceived quality of these interactions (poor, fair, good, very good, excellent).	Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Other	Improvement in self-efficacy discussing LDKT measured through Living Donation Kidney Transplant Self-Efficacy scale (LDKT-SE) score	Patient's self-efficacy towards doing activities to pursue LDKT (e.g. willingness and confidence to approach others for donation, following-up with potential donors) is measured through a self-report instrument, the Living Donation Kidney Transplant Self-Efficacy (LDKT-SE) scale. A higher score on this assessment indicates higher self-efficacy for patients pursuing LDKT.	Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Primary	Live donor kidney transplants	The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year.	1 Year Post-Intervention
Secondary	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.	1 Year Post-Intervention
Secondary	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.	1 Year Post-Intervention