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Trial record 1 of 1 for:    NCT03354910
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House Calls and Peer Mentorship (HC+PM)

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ClinicalTrials.gov Identifier: NCT03354910
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE October 23, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE April 30, 2018
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 28, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: November 21, 2017)
  • 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 ]
    We will determine whether this intervention increase a patient's knowledge of LDKT. An improvement in patient knowledge will be measured using 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.
  • 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 ]
    We will determine whether this intervention increases a patient's readiness to pursue LDKT. Patient readiness will be measured using 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.
  • 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 ]
    We will determine whether this intervention reduces mistrust towards the health care system. This 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.
  • 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 ]
    As part of the study, we will determine whether this intervention reduces patient's concerns towards LDKT. This 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.
  • 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 ]
    As part of the study, we will determine whether this intervention increases the time patients speak with others about LDKT and whether these interactions are of higher quality compared to pre-intervention. This 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).
  • 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 ]
    As part of the study, we will determine whether this intervention increases the 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). This 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.
 
Descriptive Information
Brief Title  ICMJE House Calls and Peer Mentorship
Official Title  ICMJE Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Chronic Kidney Disease
  • End-Stage Renal Disease
Intervention  ICMJE
  • Behavioral: House Call
    60 to 90 minute home based educational intervention which will be administered by a health educator.
  • Behavioral: Peer Mentorship
    A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.
Study Arms  ICMJE
  • No Intervention: Usual Care
    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.
  • Active Comparator: Usual Care (UC) + House Calls (HC)
    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.
    Intervention: Behavioral: House Call
  • Experimental: UC + HC + Peer Mentorship
    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.
    Interventions:
    • Behavioral: House Call
    • Behavioral: Peer Mentorship
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
374
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James R Rodrigue, Ph.D. 6176329821 jrrodrig@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03354910
Other Study ID Numbers  ICMJE 2017P000521
PCORI 1609-36589 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party James Rodrigue, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE
  • Medical University of South Carolina
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: James R Rodrigue, Ph.D. Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP