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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932334
First Posted: July 3, 2009
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  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: None (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 ]

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
Usual Care
Participants receive their usual medical care
Behavioral: Usual Care
Participants receive their usual care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932334


Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Leigh E Boulware, MD,MPH Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00932334     History of Changes
Other Study ID Numbers: NA_00006752
R39OT07537
First Submitted: July 2, 2009
First Posted: July 3, 2009
Last Update Posted: December 11, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
kidney
transplant
donation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency