Kidney Transplant CandidatesNCT01855438
Increasing Communication About Live Donor Kidney Transplant
A study testing Living Donor Transplant Education in people with Kidney Transplant Candidates, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study will test the efficacy of a communication intervention intended to increase and improve kidney transplant candidates' communication about live donor kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Candidates
- What is being tested?
- Living Donor Transplant Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- May 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 (i.e., status 1 or 2)
- 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 or wait listed, but not in active status
- Under 18 years of age
- Non-English speaking
- Cognitively impaired
- Institutionalized
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Increasing Communication About Live Donor Kidney Transplant: A Proof of Concept
This study will test the efficacy of a communication intervention intended to increase and improve kidney transplant candidates' communication about live donor kidney transplantation.
- Conditions
- Kidney Transplant Candidates
- Being tested
- Living Donor Transplant Education
- Keywords
- Live donor kidney transplantation, Living donation, Patient education, Kidney transplant candidates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Donor Transplant EducationBehavioural
The Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Kidney transplant candidates randomized to this arm will receive only the education provided by the transplant center. After data collection activities have concluded, transplant candidates in this arm will be offered the opportunity to attend a program session. |
| Living Donor Transplant Education 1 | Experimental | Participants randomized to Living Donor Transplant Education 1 will receive education on living donor kidney transplantation and its discussion. Receives: Behavioral: Living Donor Transplant Education |
| Living Donor Transplant Education 2 | Experimental | Participants randomized to Living Donor Transplant Education 2 will receive education on living donor kidney transplantation and its discussion; they will also have the opportunity to practice discussing living kidney transplantation with simulated patients portraying participants' conversational partners. Receives: Behavioral: Living Donor Transplant Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of individuals screened as potential living donors
1 self-reported item
Measured: Upon enrollment (baseline); 1 month post; 3 months post
Secondary outcomes (3)
Change in intentions to discuss live donor kidney transplantation
3-item, 7-point Likert-type scale
Measured: Upon enrollment (baseline); 1 month post; 3 months post
Change in engagement in discussion about live donor kidney transplantation
2 self-reported items: whether live donor kidney transplantation was discussed (yes/no) and number of discussions held
Measured: Upon enrollment (baseline); 1 month post; 3 months post
Change in the number of living donor kidney transplants performed
Measured: At study commencement; after all program sessions (interventions) are completed; at study conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startMay 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 Kidney Transplant CandidatesStudies 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Heather M Traino, PhD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855438
- Sponsor's protocol ID
- HM12097
- Other IDs
- PD302305
- Status last verified
- Feb 2018
- First submitted
- 13 May 2013
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Communication About Live Donor Kidney Transplant: A Proof of Concept
- ClinicalTrials.gov ID
- NCT01855438
- Acronym / sponsor ID
- HM12097
- Conditions
- Kidney Transplant Candidates
- Keywords
- Live donor kidney transplantation, Living donation, Patient education, Kidney transplant candidates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- May 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 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.
This study will test the efficacy of a communication intervention intended to increase and improve kidney transplant candidates' communication about live donor kidney transplantation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Kidney transplant candidates randomized to this arm will receive only the education provided by the transplant center. After data collection activities have concluded, transplant candidates in this arm will be offered the opportunity to attend a program session. |
| Living Donor Transplant Education 1 | Experimental | Behavioral: Living Donor Transplant EducationParticipants randomized to Living Donor Transplant Education 1 will receive education on living donor kidney transplantation and its discussion. |
| Living Donor Transplant Education 2 | Experimental | Behavioral: Living Donor Transplant EducationParticipants randomized to Living Donor Transplant Education 2 will receive education on living donor kidney transplantation and its discussion; they will also have the opportunity to practice discussing living kidney transplantation with simulated patients portraying participants' conversational partners. |
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 (i.e., status 1 or 2)
- Adult (at least 18 years of age)
- English speaking
- Capable of making medical decisions (i.e., not cognitively impaired)
- Non-institutionalized
Key exclusion criteria (5 listed)
- Not listed for kidney transplantation or wait listed, but not in active status
- Under 18 years of age
- Non-English speaking
- Cognitively impaired
- Institutionalized
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 |
|---|---|---|
| Living Donor Transplant EducationThe Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic. | Behavioural | Living Donor Transplant Education 1, Living Donor Transplant Education 2 |
Primary outcome
Change in the number of individuals screened as potential living donors
Time frame: Upon enrollment (baseline); 1 month post; 3 months post
1 self-reported item
3 secondary outcomes
Change in intentions to discuss live donor kidney transplantation
Time frame: Upon enrollment (baseline); 1 month post; 3 months post
Change in engagement in discussion about live donor kidney transplantation
Time frame: Upon enrollment (baseline); 1 month post; 3 months post
Change in the number of living donor kidney transplants performed
Time frame: At study commencement; after all program sessions (interventions) are completed; at study conclusion
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 20 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 Living Donor Transplant Education in people with Kidney Transplant Candidates, 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 5 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 20 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 the number of individuals screened as potential living donors (time frame: Upon enrollment (baseline); 1 month post; 3 months post). 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 20 Feb 2018.