Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation (TALK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leigh Ebony Boulware, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00932334
First received: July 2, 2009
Last updated: March 26, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932334

Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Leigh E Boulware, MD,MPH Johns Hopkins Medical Institutions
  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 April 17, 2014