Network Interventions to Reduce Disparities in Living Kidney Donation

End-stage Renal Disease Clinical Trial

Official title:

Social Network Interventions to Reduce Race Disparities in Living Kidney Donation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255757
• Other study ID #: 849197
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: September 2023
• Source: Penn State University
• Contact: Jonathan Daw, PhD
• Phone: 814-7531329
• Email: jddaw[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• Script Intervention
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.

Locations

Country	Name	City	State
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	Penn Medicine-- University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Penn State University	University of Alabama at Birmingham, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Received a living donor kidney transplant	Living donor kidney transplant received by patient	up to 3 years
Primary	Received a deceased donor kidney transplant	Deceased donor kidney transplant received by patient	up to 3 years
Primary	Death	Patient died during the follow-up period	up to 3 years
Primary	Completed living kidney donor screening questionnaires	Number of completed living kidney donation screening questionnaires completed for patient	up to 3 years
Primary	Preliminary approval from living kidney donor screening questionnaires	Number of completed living kidney donor screening that received preliminary approval for patient	up to 3 years
Primary	Completed living kidney donor evaluations	Number of living kidney donor evaluations completed for patient	up to 3 years
Primary	Approvals for living kidney donor candidacy	Number of completed living kidney donor evaluations that resulted in approved living kidney donor candidacy for patient	up to 3 years
Secondary	Preference for living kidney donor	A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding preference for living kidney donor	Immediate
Secondary	Concerns about living kidney donation	A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding concerns for living kidney donation	Immediate
Secondary	Living donor kidney transplant willingness	A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding living donor kidney transplant willingness	Immediate
Secondary	Self-rated kidney transplant knowledge	Respondent is asked to rate their level of knowledge related to kidney transplantation.	Immediate
Secondary	Trust in medical institutions	Respondent is asked to rate their trust in medical institutions.	Immediate
Secondary	Religious views' effect on kidney transplant willingness	Respondent is asked how strongly they agree that their religious views affect their willingness to pursue a kidney transplant.	Immediate