Kidney TransplantNCT01261910
Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
A study testing Intensive initial education in people with Kidney Transplant and Living-Donor Kidney Transplant, run by St. Barnabas Medical Center at 1 site in United States.
Trial summary
The primary purpose of this study is to test different methods by which kidney transplant centers can educate potential transplant candidates about living donor kidney transplant (LDKT). The most effective ways to educate kidney transplant candidates about LDKT remain unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Living-Donor Kidney Transplant, Chronic Kidney Disease
- What is being tested?
- Intensive initial education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2013
- 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
- Appear for initial kidney transplant evaluation at Saint Barnabas Medical Center
- 18 years of age or older
- Able to provide informed consent
- Able to speak, hear, and understand English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
About this study
The primary purpose of this study is to test different methods by which kidney transplant centers can educate potential transplant candidates about living donor kidney transplant (LDKT).
The most effective ways to educate kidney transplant candidates about LDKT remain unclear. The goal is to determine, among a diverse cohort of potential kidney transplant candidates, whether a transplant center-based intervention will increase understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT. The investigators hypothesize that kidney transplant candidates' understanding of living kidney donation and LDKT will be increased by interventions implemented at the transplant center on the day of transplant evaluation.
Read more
The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to compare the effects of two educational strategies upon transplant candidates' understanding of living kidney donation and LDKT:
- Usual transplant education implemented by the transplant center, on the day of the transplant evaluation (standard care); and
- Intensive initial transplant education implemented on the day of the transplant evaluation.
Intensive initial transplant education will utilize videos of living donors' experiences as well as a session with a trained Transplant Educator, who will focus upon living donation education. One week after the transplant evaluation day and 3 months later, the investigators will assess transplant candidates' knowledge of LDKT (using questionnaires), identify correlates of increased understanding of LDKT, and assess racial/ethnic differences in the understanding of LDKT.
- Conditions
- Kidney Transplant, Living-Donor Kidney Transplant, Chronic Kidney Disease, End-stage Renal Disease
- Being tested
- Intensive initial education
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive initial educationBehavioural
Participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person.
| Study group | Role | What they receive |
|---|---|---|
| Usual education (standard care) | No intervention | On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant. |
| Intensive initial education | Experimental | On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant. In addition, participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person. Receives: Behavioral: Intensive initial education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Measured: Up to 1 week after the transplant education day
Secondary outcomes (3)
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Measured: Three months after the transplant education day
Attitudes, confidence, and opinions regarding living kidney donation and LDKT
Measured: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT
Measured: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day, compared to prior to the transplant evaluation day (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies 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
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Barnabas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Dentistry of New Jersey, Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Francis L Weng, MD, Principal investigator, St. Barnabas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261910
- Sponsor's protocol ID
- SBMC-2009-53
- Status last verified
- Jul 2014
- First submitted
- 14 Dec 2010
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.
PubMed 36472416Weng FL, Brown DR, Peipert JD, Holland B, Waterman AD. Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates. BMC Nephrol. 2013 Nov 19;14:256. doi: 10.1186/1471-2369-14-256.
PubMed 24245948
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
- ClinicalTrials.gov ID
- NCT01261910
- Acronym / sponsor ID
- SBMC-2009-53
- Conditions
- Kidney Transplant, Living-Donor Kidney Transplant, Chronic Kidney Disease, End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- St. Barnabas Medical CenterUniversity, hospital or other
- Collaborators
- University of Medicine and Dentistry of New Jersey, Health Resources and Services Administration (HRSA)
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Dec 2010 (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 primary purpose of this study is to test different methods by which kidney transplant centers can educate potential transplant candidates about living donor kidney transplant (LDKT).
The most effective ways to educate kidney transplant candidates about LDKT remain unclear. The goal is to determine, among a diverse cohort of potential kidney transplant candidates, whether a transplant center-based intervention will increase understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT. The investigators hypothesize that kidney transplant candidates' understanding of living kidney donation and LDKT will be increased by interventions implemented at the transplant center on the day of transplant evaluation.
The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to compare the effects of two educational strategies upon transplant candidates' understanding of living kidney donation and LDKT:
- Usual transplant education implemented by the transplant center, on the day of the transplant evaluation (standard care); and
- Intensive initial transplant education implemented on the day of the transplant evaluation.
Intensive initial transplant education will utilize videos of living donors' experiences as well as a session with a trained Transplant Educator, who will focus upon living donation education. One week after the transplant evaluation day and 3 months later, the investigators will assess transplant candidates' knowledge of LDKT (using questionnaires), identify correlates of increased understanding of LDKT, and assess racial/ethnic differences in the understanding of LDKT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual education (standard care) | No intervention | –On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant. |
| Intensive initial education | Experimental | Behavioral: Intensive initial educationOn the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant. In addition, participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Appear for initial kidney transplant evaluation at Saint Barnabas Medical Center
- 18 years of age or older
- Able to provide informed consent
- Able to speak, hear, and understand English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intensive initial educationParticipants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person. | Behavioural | Intensive initial education |
Primary outcome
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Time frame: Up to 1 week after the transplant education day
3 secondary outcomes
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Time frame: Three months after the transplant education day
Attitudes, confidence, and opinions regarding living kidney donation and LDKT
Time frame: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT
Time frame: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day, compared to prior to the transplant evaluation day (baseline)
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 Jul 2014.
- Derived from this study: PubMed 36472416Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.
- Derived from this study: PubMed 24245948Weng FL, Brown DR, Peipert JD, Holland B, Waterman AD. Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates. BMC Nephrol. 2013 Nov 19;14:256. doi: 10.1186/1471-2369-14-256.
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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.
Francis L Weng, MD principal investigator
St. Barnabas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive initial education in people with Kidney Transplant and Living-Donor Kidney Transplant, run by St. Barnabas Medical Center 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 4 inclusion and 0 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 Jul 2014. 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?
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT (time frame: Up to 1 week after the transplant education day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01261910, which also lists 2 linked publications.
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 Jul 2014.