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Completed

NCT Number: NCT03354910

House Calls and Peer Mentorship

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

House Call

Behavioral

60 to 90 minute home based educational intervention which will be administered by a health educator.

Peer Mentorship

Behavioral

A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Live donor evaluations

    Time frame: 1 Year Post-Intervention

    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.

  2. Live donor inquiries

    Time frame: 1 Year Post-Intervention

    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.

Other outcomes

  1. Improvement in live donor kidney transplant knowledge measured through Living Donation Kidney Transplant Knowledge (LDKT-K) scale score

    Time frame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

    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.

  2. Improvement in live donor kidney transplant readiness measured through Living Donation Kidney Transplant Readiness scale (LDKT-R) score

    Time frame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

    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.

  3. Reduced health care mistrust measured through Health Care Distrust Scale (HCDS) score

    Time frame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

    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.

  4. Reduced live donor kidney transplant concerns measured through measured Living Donation Kidney Transplant Concerns scale (LDKT-C) score

    Time frame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

    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.

  5. Greater amount of time spent discussing LDKT and higher quality interactions measured through the Talking About Living Donation (TaLKeD) instrument

    Time frame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

    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).

  6. Improvement in self-efficacy discussing LDKT measured through Living Donation Kidney Transplant Self-Efficacy scale (LDKT-SE) score

    Time frame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

    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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Medical University of South Carolina
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: HC+PM

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 28, 2017
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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