Overview

This trial is active, not recruiting.

Condition kidney transplant candidates
Treatment living donor transplant education
Sponsor Virginia Commonwealth University
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date May 2013
End date April 2016
Trial size 240 participants
Trial identifier NCT01855438, PD302305

Summary

This study will test the efficacy of a communication intervention intended to increase and improve kidney transplant candidates' communication about live donor kidney transplantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose health services research
Arm
(No Intervention)
Kidney transplant candidates randomized to this arm will receive only the education provided by the transplant center. After data collection activities have concluded, transplant candidates in this arm will be offered the opportunity to attend a program session.
(Experimental)
Participants randomized to Living Donor Transplant Education 1 will receive education on living donor kidney transplantation and its discussion.
living donor transplant education
The Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic.
(Experimental)
Participants randomized to Living Donor Transplant Education 2 will receive education on living donor kidney transplantation and its discussion; they will also have the opportunity to practice discussing living kidney transplantation with simulated patients portraying participants' conversational partners.
living donor transplant education
The Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic.

Primary Outcomes

Measure
Change in the number of individuals screened as potential living donors
time frame: Upon enrollment (baseline); 1 month post; 3 months post

Secondary Outcomes

Measure
Change in intentions to discuss live donor kidney transplantation
time frame: Upon enrollment (baseline); 1 month post; 3 months post
Change in engagement in discussion about live donor kidney transplantation
time frame: Upon enrollment (baseline); 1 month post; 3 months post
Change in the number of living donor kidney transplants performed
time frame: At study commencement; after all program sessions (interventions) are completed; at study conclusion

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Wait listed for kidney transplantation in active status (i.e., status 1 or 2) - Adult (at least 18 years of age) - English speaking - Capable of making medical decisions (i.e., not cognitively impaired) - Non-institutionalized Exclusion Criteria: - Not listed for kidney transplantation or wait listed, but not in active status - Under 18 years of age - Non-English speaking - Cognitively impaired - Institutionalized

Additional Information

Official title Increasing Communication About Live Donor Kidney Transplant: A Proof of Concept
Principal investigator Heather M Traino, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.