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Communicating About Choices in Transplantation (COACH)

Primary Purpose

End Stage Renal Disease and Kidney Transplantation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COACH Program
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease and Kidney Transplantation focused on measuring End stage renal disease, Kidney transplantation, Transplant options (living and deceased donor), Patient education, Communication skills training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

COACH Program

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in engagement in discussion of living and deceased donor transplantation
2 self-report items: whether transplantation was discussed (yes/no) and the number of discussions held
Change in knowledge of living and deceased donor transplant
15 True/False Questions

Secondary Outcome Measures

Change in intentions to discuss living and deceased donor transplantation
3-item, 7-point Likert-type scale

Full Information

First Posted
May 7, 2013
Last Updated
February 27, 2018
Sponsor
Virginia Commonwealth University
Collaborators
Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT01853007
Brief Title
Communicating About Choices in Transplantation
Acronym
COACH
Official Title
Communicating About Choices in Transplantation (COACH)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Health Resources and Services Administration (HRSA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease and Kidney Transplantation
Keywords
End stage renal disease, Kidney transplantation, Transplant options (living and deceased donor), Patient education, Communication skills training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Arm Title
COACH Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COACH Program
Primary Outcome Measure Information:
Title
Change in engagement in discussion of living and deceased donor transplantation
Description
2 self-report items: whether transplantation was discussed (yes/no) and the number of discussions held
Time Frame
Baseline (upon enrollment); 1 month post; 3 months post
Title
Change in knowledge of living and deceased donor transplant
Description
15 True/False Questions
Time Frame
Upon enrollment (baseline); 1 month post; 2 months post
Secondary Outcome Measure Information:
Title
Change in intentions to discuss living and deceased donor transplantation
Description
3-item, 7-point Likert-type scale
Time Frame
Upon enrollment (baseline); 1 month post; 3 months post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather M Traino, PhD, MPH
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Communicating About Choices in Transplantation

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