Network Interventions to Reduce Disparities in Living Kidney Donation

NCT ID: NCT05255757

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

There are two interventions randomly assigned to participants in a factorial experimental design. The first intervention is the search intervention. In addition to the candidate survey, transplant candidates assigned to this intervention will be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation. The second intervention is the script intervention, where in addition to the survey, transplant candidates will review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. 25% of participants will be assigned to each of the following factorial experimental groups: no intervention, search intervention only, script intervention only, or both search and script intervention.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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No intervention

This group will only complete study survey and refer members of their family and social network for participation in a web survey.

Group Type NO_INTERVENTION

No interventions assigned to this group

Script Intervention

This group will complete the survey, refer members of their family and social network for participation in a web survey, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network.

Group Type EXPERIMENTAL

Script Intervention

Intervention Type BEHAVIORAL

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

Search Intervention

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.

Group Type EXPERIMENTAL

Search Intervention

Intervention Type 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.

Both Search and Script Intervention

This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network.

Group Type EXPERIMENTAL

Script Intervention

Intervention Type BEHAVIORAL

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

Search Intervention

Intervention Type 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.

Interventions

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Script Intervention

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

Intervention Type BEHAVIORAL

Search Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Daw

Associate Professor of Sociology and Demography

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama-Birmingham

Birmingham, Alabama, United States

Site Status

Penn Medicine-- University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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849197

Identifier Type: -

Identifier Source: org_study_id

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