Chronic Kidney DiseaseTALKNCT00932334
Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation
A study testing TALK PLUS and TALK Standard in people with Chronic Kidney Disease, run by Johns Hopkins University.
Trial summary
Title: Culturally tailored behavioral interventions to enhance living kidney donation/living kidney transplantation Applicants: Johns Hopkins Medical Institutions, National Kidney Foundation of Maryland Principal Investigator: Neil R. Powe, MD, MPH, MBA Address: 2024 E. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- TALK PLUS and TALK Standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to May 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 with stage IV or stage V (non-dialysis dependent) chronic kidney disease
Who cannot join
- No evidence of cancer within 2 years prior to recruitment date
- No evidence of stage IV congestive heart failure
- No evidence of end-stage liver disease
- No evidence of unstable coronary artery disease
- No evidence of pulmonary hypertension
- No evidence of severe peripheral vascular disease
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- No history of HIV
- No chronic (debilitating) infections
- No prior kidney transplant
- No prior completion of transplant evaluation process
- No prior dialysis treatment
About this study
Title: Culturally tailored behavioral interventions to enhance living kidney donation/living kidney transplantation Applicants: Johns Hopkins Medical Institutions, National Kidney Foundation of Maryland Principal Investigator: Neil R. Powe, MD, MPH, MBA Address: 2024 E. Monument Street, Suite 2-600, Baltimore, MD, 21205 Phone: 410-955-6953; Email: npowe@jhmi.edu; Fax: 410-955-0476 Rates of kidney donation have been largely stagnant for the past 10 years, resulting in large imbalances in numbers of persons on transplant waiting lists and the number of persons receiving kidney transplants. Slow improvement in donation and transplantation rates are exacerbated by ethnic/racial disparities in kidney transplants, in which minorities, particularly African Americans, are far less likely to receive deceased kidney transplants. Although living related kidney donation (LD) offers patients an opportunity to bypass many barriers contributing to disparities in kidney transplantation (e.g. waiting lists and immunological incompatibility issues), African Americans remain less likely to receive living related kidney transplants (LRT), further exacerbating disparities in transplant rates. Recent research demonstrates many ethnic minorities desire kidney transplantation, but rates of patient-physician and patient-family discussions regarding LD/LRT are suboptimal. Compared to Whites, African Americans have also been shown to have disproportionately greater rates of culture-specific concerns (such as mistrust in health care) that could impede them from seeking important medical therapies. It is unknown whether culturally tailored behavioral interventions to enhance patient/family decision-making regarding LD/LRT before the onset of end stage renal disease could improve rates of LD/LRT or could narrow racial disparities in the receipt of transplantation. The primary goal of this proposal is a) to use focus group methodology to develop culturally tailored educational materials for patients/families considering LD/LRT and b) to perform a randomized controlled trial to test the effectiveness of a culturally tailored social-worker led intervention (using established behavioral problem-solving therapeutic techniques) in enhancing rates of family communication, donor evaluations, and transplantation. The substantial experience of our consortium, including the National Kidney Foundation of Maryland and the Johns Hopkins Medical Institutions (Welch Center and the Medical Surgical Transplant Services in the School of Medicine), in the evaluation/ implementation of donor/recipient educational programs as well as the conduct of behavioral, epidemiologic and interventional studies related to donor/recipient health and psychology provides a strong foundation for the conduct of this study.
- Conditions
- Chronic Kidney Disease
- Being tested
- TALK PLUS, TALK Standard, Usual Care
- Keywords
- kidney, transplant, donation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TALK PLUSBehavioural
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
TALK StandardBehavioural
Participants receive and educational video and booklet about living kidney donation
Usual CareBehavioural
Participants receive their usual care
| Study group | Role | What they receive |
|---|---|---|
| TALK Plus | Experimental | Participants receive and educational video and booklet about living kidney donation and meet with a social worker Receives: Behavioral: TALK PLUS |
| TALK Standard | Experimental | Participants receive and educational video and booklet about living kidney donation Receives: Behavioral: TALK Standard |
| Usual Care | Other | Participants receive their usual medical care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
enhancing rates of family communication, donor evaluations, and transplantation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh E Boulware, MD,MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932334
- Sponsor's protocol ID
- NA_00006752
- Other IDs
- R39OT07537
- Acronym
- TALK
- Status last verified
- Dec 2017
- First submitted
- 2 Jul 2009
- Last updated
- 11 Dec 2017
- 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 36472416Boulware LE, Hill-Briggs F, Kraus ES, Melancon JK, Falcone B, Ephraim PL, Jaar BG, Gimenez L, Choi M, Senga M, Kolotos M, Lewis-Boyer L, Cook C, Light L, DePasquale N, Noletto T, Powe NR. Effectiveness of educational and social worker interventions to activate patients' discussion and pursuit of preemptive living donor kidney transplantation: a randomized controlled trial. Am J Kidney Dis. 2013 Mar;61(3):476-86. doi: 10.1053/j.ajkd.2012.08.039. Epub 2012 Oct 22.
PubMed 23089512Boulware LE, Hill-Briggs F, Kraus ES, Melancon JK, McGuire R, Bonhage B, Senga M, Ephraim P, Evans KE, Falcone B, Troll MU, Depasquale N, Powe NR. Protocol of a randomized controlled trial of culturally sensitive interventions to improve African Americans' and non-African Americans' early, shared, and informed consideration of live kidney transplantation: the Talking About Live Kidney Donation (TALK) Study. BMC Nephrol. 2011 Jul 8;12:34. doi: 10.1186/1471-2369-12-34.
PubMed 21736762
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00932334
- Acronym / sponsor ID
- TALK / NA_00006752
- Conditions
- Chronic Kidney Disease
- Keywords
- kidney, transplant, donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Jul 2009 (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.
Title: Culturally tailored behavioral interventions to enhance living kidney donation/living kidney transplantation Applicants: Johns Hopkins Medical Institutions, National Kidney Foundation of Maryland Principal Investigator: Neil R. Powe, MD, MPH, MBA Address: 2024 E. Monument Street, Suite 2-600, Baltimore, MD, 21205 Phone: 410-955-6953; Email: npowe@jhmi.edu; Fax: 410-955-0476 Rates of kidney donation have been largely stagnant for the past 10 years, resulting in large imbalances in numbers of persons on transplant waiting lists and the number of persons receiving kidney transplants. Slow improvement in donation and transplantation rates are exacerbated by ethnic/racial disparities in kidney transplants, in which minorities, particularly African Americans, are far less likely to receive deceased kidney transplants. Although living related kidney donation (LD) offers patients an opportunity to bypass many barriers contributing to disparities in kidney transplantation (e.g. waiting lists and immunological incompatibility issues), African Americans remain less likely to receive living related kidney transplants (LRT), further exacerbating disparities in transplant rates. Recent research demonstrates many ethnic minorities desire kidney transplantation, but rates of patient-physician and patient-family discussions regarding LD/LRT are suboptimal. Compared to Whites, African Americans have also been shown to have disproportionately greater rates of culture-specific concerns (such as mistrust in health care) that could impede them from seeking important medical therapies. It is unknown whether culturally tailored behavioral interventions to enhance patient/family decision-making regarding LD/LRT before the onset of end stage renal disease could improve rates of LD/LRT or could narrow racial disparities in the receipt of transplantation. The primary goal of this proposal is a) to use focus group methodology to develop culturally tailored educational materials for patients/families considering LD/LRT and b) to perform a randomized controlled trial to test the effectiveness of a culturally tailored social-worker led intervention (using established behavioral problem-solving therapeutic techniques) in enhancing rates of family communication, donor evaluations, and transplantation. The substantial experience of our consortium, including the National Kidney Foundation of Maryland and the Johns Hopkins Medical Institutions (Welch Center and the Medical Surgical Transplant Services in the School of Medicine), in the evaluation/ implementation of donor/recipient educational programs as well as the conduct of behavioral, epidemiologic and interventional studies related to donor/recipient health and psychology provides a strong foundation for the conduct of this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TALK Plus | Experimental | Behavioral: TALK PLUSParticipants receive and educational video and booklet about living kidney donation and meet with a social worker |
| TALK Standard | Experimental | Behavioral: TALK StandardParticipants receive and educational video and booklet about living kidney donation |
| Usual Care | Other | Behavioral: Usual CareParticipants receive their usual medical care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 to 70 with stage IV or stage V (non-dialysis dependent) chronic kidney disease
Key exclusion criteria (11 listed)
- No evidence of cancer within 2 years prior to recruitment date
- No evidence of stage IV congestive heart failure
- No evidence of end-stage liver disease
- No evidence of unstable coronary artery disease
- No evidence of pulmonary hypertension
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 |
|---|---|---|
| TALK PLUSParticipants receive and educational video and booklet about living kidney donation and meet with a social worker | Behavioural | TALK Plus |
| TALK StandardParticipants receive and educational video and booklet about living kidney donation | Behavioural | TALK Standard |
| Usual CareParticipants receive their usual care | Behavioural | Usual Care |
Primary outcome
enhancing rates of family communication, donor evaluations, and transplantation
Time frame: 6 months
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 11 Dec 2017.
- 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 23089512Boulware LE, Hill-Briggs F, Kraus ES, Melancon JK, Falcone B, Ephraim PL, Jaar BG, Gimenez L, Choi M, Senga M, Kolotos M, Lewis-Boyer L, Cook C, Light L, DePasquale N, Noletto T, Powe NR. Effectiveness of educational and social worker interventions to activate patients' discussion and pursuit of preemptive living donor kidney transplantation: a randomized controlled trial. Am J Kidney Dis. 2013 Mar;61(3):476-86. doi: 10.1053/j.ajkd.2012.08.039. Epub 2012 Oct 22.
- Derived from this study: PubMed 21736762Boulware LE, Hill-Briggs F, Kraus ES, Melancon JK, McGuire R, Bonhage B, Senga M, Ephraim P, Evans KE, Falcone B, Troll MU, Depasquale N, Powe NR. Protocol of a randomized controlled trial of culturally sensitive interventions to improve African Americans' and non-African Americans' early, shared, and informed consideration of live kidney transplantation: the Talking About Live Kidney Donation (TALK) Study. BMC Nephrol. 2011 Jul 8;12:34. doi: 10.1186/1471-2369-12-34.
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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.
Leigh E Boulware, MD,MPH principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing TALK PLUS and TALK Standard in people with Chronic Kidney Disease, run by Johns Hopkins University.
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 1 inclusion and 11 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 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
enhancing rates of family communication, donor evaluations, and transplantation (time frame: 6 months). 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 NCT00932334, which also lists 3 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 11 Dec 2017.