End Stage Renal Disease and Kidney TransplantationCOACHNCT01853007
Communicating About Choices in Transplantation
A study testing COACH Program in people with End Stage Renal Disease and Kidney Transplantation, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease and Kidney Transplantation
- What is being tested?
- COACH Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not listed for kidney transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the 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.
- Being tested
- COACH Program
- Keywords
- End stage renal disease, Kidney transplantation, Transplant options (living and deceased donor), Patient education, Communication skills training
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COACH ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual care | 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. |
| COACH Program | Experimental | 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. Receives: Behavioral: COACH Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (upon enrollment); 1 month post; 3 months post
Change in knowledge of living and deceased donor transplant
15 True/False Questions
Measured: Upon enrollment (baseline); 1 month post; 2 months post
Secondary outcomes (1)
Change in intentions to discuss living and deceased donor transplantation
3-item, 7-point Likert-type scale
Measured: Upon enrollment (baseline); 1 month post; 3 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease and Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Heather M Traino, PhD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853007
- Sponsor's protocol ID
- PD301152
- Acronym
- COACH
- Status last verified
- Feb 2018
- First submitted
- 7 May 2013
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating About Choices in Transplantation (COACH)
- ClinicalTrials.gov ID
- NCT01853007
- Acronym / sponsor ID
- COACH / PD301152
- Keywords
- End stage renal disease, Kidney transplantation, Transplant options (living and deceased donor), Patient education, Communication skills training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Jun 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | 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. |
| COACH Program | Experimental | Behavioral: COACH ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not listed for kidney transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COACH Program | Behavioural | COACH Program |
Primary outcome
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
Change in knowledge of living and deceased donor transplant
Time frame: Upon enrollment (baseline); 1 month post; 2 months post
15 True/False Questions
1 secondary outcome
Change in intentions to discuss living and deceased donor transplantation
Time frame: Upon enrollment (baseline); 1 month post; 3 months post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather M Traino, PhD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COACH Program in people with End Stage Renal Disease and Kidney Transplantation, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in engagement in discussion of living and deceased donor transplantation (time frame: Baseline (upon enrollment); 1 month post; 3 months post). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.