Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: TALK PLUS
* Behavioral: TALK Standard
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TALK Plus<br>Participants receive and educational video and booklet about living kidney donation and meet with a social worker | Behavioral: TALK PLUS<br>* Participants receive and educational video and booklet about living kidney donation and meet with a social worker<br>|
| Experimental: TALK Standard<br>Participants receive and educational video and booklet about living kidney donation | Behavioral: TALK Standard<br>* Participants receive and educational video and booklet about living kidney donation<br>|
| Other: Usual Care<br>Participants receive their usual medical care | Behavioral: Usual Care<br>* Participants receive their usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enhancing rates of family communication, donor evaluations, and transplantation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney, transplant, donation