Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation (TALK)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease |
Behavioral: TALK PLUS Behavioral: TALK Standard Behavioral: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation |
- enhancing rates of family communication, donor evaluations, and transplantation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 145 |
| Study Start Date: | February 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TALK Plus
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
|
Behavioral: TALK PLUS
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
|
|
Experimental: TALK Standard
Participants receive and educational video and booklet about living kidney donation
|
Behavioral: TALK Standard
Participants receive and educational video and booklet about living kidney donation
|
|
No Intervention: Usual Care
Participants receive their usual medical care
|
Behavioral: Usual Care
Participants receive their usual care
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided by Johns Hopkins University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Leigh Ebony Boulware, Associate Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00932334 History of Changes |
| Other Study ID Numbers: | NA_00006752, R39OT07537 |
| Study First Received: | July 2, 2009 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Johns Hopkins University:
|
kidney transplant donation |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013