Communicating About Choices in Transplantation (COACH)

February 27, 2018 updated by: Virginia Commonwealth University

Communicating About Choices in Transplantation (COACH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
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.
Experimental: COACH 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.
Behavioral: COACH Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in engagement in discussion of living and deceased donor transplantation
Time Frame: Baseline (upon enrollment); 1 month post; 3 months post
2 self-report items: whether transplantation was discussed (yes/no) and the number of discussions held
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
15 True/False Questions
Upon enrollment (baseline); 1 month post; 2 months post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intentions to discuss living and deceased donor transplantation
Time Frame: Upon enrollment (baseline); 1 month post; 3 months post
3-item, 7-point Likert-type scale
Upon enrollment (baseline); 1 month post; 3 months post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Heather M Traino, PhD, MPH, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD301152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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