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

Chronic Kidney Disease Clinical Trial

— TALK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932334
• Other study ID #: NA_00006752
• Secondary ID: R39OT07537
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: December 7, 2017
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• TALK PLUS
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
• TALK Standard
Participants receive and educational video and booklet about living kidney donation
• Usual Care
Participants receive their usual care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	enhancing rates of family communication, donor evaluations, and transplantation		6 months