This trial is active, not recruiting.

Condition end stage renal disease and kidney transplantation
Treatment coach program
Sponsor Virginia Commonwealth University
Collaborator Health Resources and Services Administration (HRSA)
Start date June 2013
End date April 2016
Trial size 158 participants
Trial identifier NCT01853007, PD301152


The purpose of this study is to test the impact of a newly developed educational program on kidney transplant candidates' communication about living and deceased 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
(No Intervention)
Patients in this arm will receive only the education offered by the transplant center, as required by Medicaid. Upon completion of all data collection activities, patients in this arm will be offered the program.
Participants randomized to the intervention condition will attend a COACH session held in a small group format. The session provides information on living and deceased donor transplantation (i.e., the processes, risks and benefits) and on the key communication skills needed to effectively initiate and maintain conversations about transplantation.
coach program

Primary Outcomes

Change in engagement in discussion of living and deceased donor transplantation
time frame: Baseline (upon enrollment); 1 month post; 3 months post
Change in knowledge of living and deceased donor transplant
time frame: Upon enrollment (baseline); 1 month post; 2 months post

Secondary Outcomes

Change in intentions to discuss living and deceased donor transplantation
time frame: Upon enrollment (baseline); 1 month post; 3 months post

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Wait listed for kidney transplantation in active status - 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

Additional Information

Official title Communicating About Choices in Transplantation (COACH)
Principal investigator Heather M Traino, PhD, MPH
Description The Communicating about Choices (COACH) in Transplantation program educates patients with end stage renal disease, who are waitlisted for kidney transplantation, about kidney disease and the risks, benefits and processes for both living and deceased donor transplantation. The program also teaches key communication skills needed to effectively initiate and manage conversations about transplantation.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.