Network Interventions to Reduce Disparities in Living Kidney Donation

NCT05255757 | Completed

• 1 other identifier: 849197
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (7)

• Received a living donor kidney transplant

  Living donor kidney transplant received by patient

  up to 3 years

• Received a deceased donor kidney transplant

  Deceased donor kidney transplant received by patient

  up to 3 years

• Death

  Patient died during the follow-up period

  up to 3 years

• Completed living kidney donor screening questionnaires

  Number of completed living kidney donation screening questionnaires completed for patient

  up to 3 years

• 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

• Completed living kidney donor evaluations

  Number of living kidney donor evaluations completed for patient

  up to 3 years

• 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 Outcomes (6)

• Preference for living kidney donor

  Immediate

• Concerns about living kidney donation

  Immediate

• Living donor kidney transplant willingness

  Immediate

• Self-rated kidney transplant knowledge

  Immediate

• Trust in medical institutions

  Immediate

Study Arms (4)

No intervention

NO INTERVENTION

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

Script Intervention

EXPERIMENTAL

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.

Behavioral: Script Intervention

Search Intervention

EXPERIMENTAL

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.

Behavioral: Search Intervention

Both Search and Script Intervention

EXPERIMENTAL

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.

Behavioral: Script Intervention; Behavioral: Search Intervention

Interventions

Script Intervention BEHAVIORAL

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

Both Search and Script Intervention; Script Intervention

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.

Both Search and Script Intervention; Search Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• University of Pennsylvania: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama-Birmingham

Birmingham, Alabama, 35233, United States

Location

Penn Medicine-- University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Sociology and Demography

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: February 25, 2022
• Study Start: October 12, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)