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OpenTrials
Completed

NCT Number: NCT05255757

Network Interventions to Reduce Disparities in Living Kidney Donation

For this current phase of the larger project, the investigators will survey transplant candidates as well as the participants family and friends to understand the barriers to volunteering and evaluation. This project will examine how network characteristics are associated with eventual living donor kidney transplant outcomes and test the efficacy of evidence-based interventions designed to assist kidney transplant candidates in participant donor search on a multi-center scale.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama-Birmingham, Birmingham, Alabama, United States

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About this study

The overall goal is to understand the process and assist participants who do not receive unsolicited offers to be evaluated as a living kidney donor in initiating and effectively conducting these critical conversations with participants kin and friends. In the search intervention, based on what they can tell investigators about the number, type, perceived health, perceived relationship, and potential willingness to donate, as well as analyses of data from the National Health and Nutrition Examination Survey (NHANES) investigators will counsel them on which members of participants family and friendship networks appear most biomedically promising as donors among the subset of these individuals that participants have not ruled out for known medical or perceived relationship reasons. In the rhetorical intervention, investigators will test non-coercive, promising verbal scripts that have proven promising in preliminary tests in vignette experiments in online and phone surveys.

AIM 1: Survey transplant candidates about their social network and transplant-related attitudes, knowledge, and characteristics; and randomize participants into one of two interventions or a control group.

AIM 2: Send network member participants a survey that measures potential donor attributes that are hypothesized to influence donation decisions, such as medical contraindications, blood type, health insurance status, and barriers to living donation.

AIM 3: Test whether participant social networks and interventions affect donation outcomes using medical records and follow-ups provided by Penn and UAB. Investigators will create the first predictive model of potential donor evaluation and actual donation. This information is critical to improve clinical practice and efforts to ethically influence the living donor search process.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are KT candidates at the University of Pennsylvania or University of Alabama-Birmingham OR were identified by KT candidate from the University of Pennsylvania or University of Alabama-Birmingham as a network member
  • Are adults aged 18 or older
  • Are able and willing to consent to participation in the survey

Exclusion criteria

  • Person is not a KT candidate at University of Pennsylvania or University of Alabama-Birmingham OR was NOT identified by KT candidate from University of Pennsylvania or University of Alabama-Birmingham as a network member
  • Individuals who are not yet 18
  • Participant does not speak English

Treatment and study plan

Script Intervention

Behavioral

This intervention provides language to participants to allow them to discuss kidney transplantation with their social network.

Search Intervention

Behavioral

This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation.

Primary outcomes

  1. Received a living donor kidney transplant

    Time frame: up to 3 years

    Living donor kidney transplant received by patient

  2. Received a deceased donor kidney transplant

    Time frame: up to 3 years

    Deceased donor kidney transplant received by patient

  3. Death

    Time frame: up to 3 years

    Patient died during the follow-up period

  4. Completed living kidney donor screening questionnaires

    Time frame: up to 3 years

    Number of completed living kidney donation screening questionnaires completed for patient

  5. Preliminary approval from living kidney donor screening questionnaires

    Time frame: up to 3 years

    Number of completed living kidney donor screening that received preliminary approval for patient

  6. Completed living kidney donor evaluations

    Time frame: up to 3 years

    Number of living kidney donor evaluations completed for patient

  7. Approvals for living kidney donor candidacy

    Time frame: up to 3 years

    Number of completed living kidney donor evaluations that resulted in approved living kidney donor candidacy for patient

Secondary outcomes

  1. Preference for living kidney donor

    Time frame: Immediate

    A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding preference for living kidney donor

  2. Concerns about living kidney donation

    Time frame: Immediate

    A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding concerns for living kidney donation

  3. Living donor kidney transplant willingness

    Time frame: Immediate

    A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding living donor kidney transplant willingness

  4. Self-rated kidney transplant knowledge

    Time frame: Immediate

    Respondent is asked to rate their level of knowledge related to kidney transplantation.

  5. Trust in medical institutions

    Time frame: Immediate

    Respondent is asked to rate their trust in medical institutions.

  6. Religious views' effect on kidney transplant willingness

    Time frame: Immediate

    Respondent is asked how strongly they agree that their religious views affect their willingness to pursue a kidney transplant.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • University of Alabama at Birmingham
  • University of Pennsylvania

Registry information

Official study title

Social Network Interventions to Reduce Race Disparities in Living Kidney Donation

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2022
Registry last updated
Oct 24, 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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