Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation (TALK)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TALK PLUS
TALK Standard
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Kidney Disease focused on measuring kidney, transplant, donation
Eligibility Criteria
Inclusion Criteria:
Age 18 to 70 with stage IV or stage V (non-dialysis dependent) chronic kidney disease
Exclusion Criteria:
- 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
- No history of HIV
- No chronic (debilitating) infections
- No prior kidney transplant
- No prior completion of transplant evaluation process
- No prior dialysis treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
TALK Plus
TALK Standard
Usual Care
Arm Description
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
Participants receive and educational video and booklet about living kidney donation
Participants receive their usual medical care
Outcomes
Primary Outcome Measures
enhancing rates of family communication, donor evaluations, and transplantation
Secondary Outcome Measures
Full Information
NCT ID
NCT00932334
First Posted
July 2, 2009
Last Updated
December 7, 2017
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00932334
Brief Title
Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation
Acronym
TALK
Official Title
Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
kidney, transplant, donation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TALK Plus
Arm Type
Experimental
Arm Description
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
Arm Title
TALK Standard
Arm Type
Experimental
Arm Description
Participants receive and educational video and booklet about living kidney donation
Arm Title
Usual Care
Arm Type
Other
Arm Description
Participants receive their usual medical care
Intervention Type
Behavioral
Intervention Name(s)
TALK PLUS
Intervention Description
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
Intervention Type
Behavioral
Intervention Name(s)
TALK Standard
Intervention Description
Participants receive and educational video and booklet about living kidney donation
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants receive their usual care
Primary Outcome Measure Information:
Title
enhancing rates of family communication, donor evaluations, and transplantation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 70 with stage IV or stage V (non-dialysis dependent) chronic kidney disease
Exclusion Criteria:
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
No history of HIV
No chronic (debilitating) infections
No prior kidney transplant
No prior completion of transplant evaluation process
No prior dialysis treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh E Boulware, MD,MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23089512
Citation
Boulware 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.
Results Reference
derived
PubMed Identifier
21736762
Citation
Boulware 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.
Results Reference
derived
Learn more about this trial
Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation
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