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Communicating About Choices in Transplantation (COACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853007
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease and Kidney Transplantation Behavioral: COACH Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Communicating About Choices in Transplantation (COACH)
Study Start Date : June 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. Change in knowledge of living and deceased donor transplant [ Time Frame: Upon enrollment (baseline); 1 month post; 2 months post ]
    15 True/False Questions


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853007


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Health Resources and Services Administration (HRSA)
Investigators
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Principal Investigator: Heather M Traino, PhD, MPH Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01853007    
Other Study ID Numbers: PD301152
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by Virginia Commonwealth University:
End stage renal disease
Kidney transplantation
Transplant options (living and deceased donor)
Patient education
Communication skills training
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency