- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853007
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
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
-
-
Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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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.
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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.
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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
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2 self-report items: whether transplantation was discussed (yes/no) and the number of discussions held
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Baseline (upon enrollment); 1 month post; 3 months post
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Change in knowledge of living and deceased donor transplant
Time Frame: Upon enrollment (baseline); 1 month post; 2 months post
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15 True/False Questions
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Upon enrollment (baseline); 1 month post; 2 months post
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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
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Upon enrollment (baseline); 1 month post; 3 months post
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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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