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Providing Resources to Enhance African American Patients' Readiness to Make Decisions About Kidney Disease (PREPARED) Study (PREPARED)

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ClinicalTrials.gov Identifier: NCT01439516
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

African Americans are less likely than Whites to receive kidney transplants, despite their being more than two-fold as likely as Whites to develop end stage renal disease (ESRD). Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to receipt of deceased kidney transplants (e.g. waiting lists and immunological incompatibility), but minorities are less likely to receive living related kidney transplants (LRT). Evidence suggests African Americans may not discuss LD/LRT with their families or physicians at optimal rates, and thus may not have adequate information to initiate or participate in shared decision-making regarding LD/LRT. African Americans may also have financial concerns regarding convalescence and out of pocket expenses related to LD/LRT, another barrier impeding LD/LRT.

The primary goals of this study are to overcome these important barriers by enhancing ethnic minorities' consideration of LD/LRT through the promotion of shared decision-making regarding LD/LRT and provision of financial assistance for out of pocket expenses. The investigators specific aims are: a) to develop culturally sensitive informational (audiovisual) and financial interventions and b) to perform a randomized controlled trial to assess their effectiveness in increasing pursuit of LD/LRT among African American patients with ESRD and their families. The investigators hypothesize: (1) Patients and families who view informational materials designed to promote shared decision-making regarding LD/LRT will be more likely than patients and families not viewing these materials to discuss LD/LRT with family and with health care professionals. Patients and families viewing such informational materials will also be more likely than those not viewing these materials to pursue and complete the LD/LRT process and (2) patients and their families who are offered the intervention to promote shared decision-making plus a financial assistance intervention for potential live kidney donors will be more likely than patients and families not offered both interventions to pursue and complete the LD/LRT process.

Condition or disease Intervention/treatment
End Stage Renal Disease (ESRD) Chronic Kidney Disease (CKD) Behavioral: Information

Detailed Description:
The investigators will enroll 210 adult African American patients with new-onset ESRD from dialysis facilities in the Baltimore metropolitan area and measure their initial commitment to pursue LD/LRT. Participants will then be randomized to one of three groups: 1) informational intervention alone (PREPARED education), 2) informational intervention plus living donor financial assistance program (PREPARED plus financial assistance), and 3) no intervention (Usual Care). The investigators will follow participants for up to 6 months for progression in their commitment to LD/LRT.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Information and Financial Interventions for Kidney Donation in African Americans
Study Start Date : August 2012
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Information
Participants randomized to this arm of the study will received the PREPARED educational book and video.
Behavioral: Information
Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)
Experimental: Information and Financial Assistance
Participants randomized to this arm of the study will receive the PREPARED educational book and video plus financial assistance for family members to cover costs associated with an evaluation for becoming a live kidney donor.
Behavioral: Information
Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)
No Intervention: Usual Care
Participants randomized to this arm of the study will receive usual care from their physician.

Outcome Measures

Primary Outcome Measures :
  1. Pursuit of Living Related Transplantation [ Time Frame: 6 months ]
    Measurement of patients' pursuit of LRT will be performed using a series of questions that assess the participants' knowledge, interest, and perceived barriers to LRT. We will also ascertain use of the living donor financial assistance among potential donors and completion of evaluation and kidney transplant among both patient participants and potential living donors.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 or older
  • End-stage renal disease (ESRD) receiving hemodialysis for less than 2 years
  • Self-reported as African-American
  • English Speaking

Exclusion Criteria:

  • Dementia
  • Prior Kidney Transplant
  • Non-English Speaking
  • Cancer within 2 years prior to recruitment date
  • Stage 4 Congestive Heart Failure
  • End Stage Liver Disease
  • Unstable Coronary Artery Disease
  • Pulmonary Hypertension
  • Severe Peripheral Vascular Disease
  • Chronic Debilitating Infections
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): NCT01439516

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Leigh Ebony Boulware, MD Johns Hopkins University
More Information

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: NCT01439516     History of Changes
Other Study ID Numbers: NA_00011846
1R01DK079682-01 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014

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