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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
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leigh Ebony Boulware, Johns Hopkins University

August 31, 2011
September 23, 2011
April 16, 2014
August 2012
April 2014   (Final data collection date for primary outcome measure)
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.
Change in Commitment to Completion of Living Donation/Living Related Transplant [ Time Frame: 6 months ]
Measurement of change in commitment to LD/LRT will be based on the Prochaska Transtheoretical Model for Stages of Change.
Complete list of historical versions of study NCT01439516 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Providing Resources to Enhance African American Patients' Readiness to Make Decisions About Kidney Disease (PREPARED) Study
Information and Financial Interventions for Kidney Donation in African Americans

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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • End Stage Renal Disease (ESRD)
  • Chronic Kidney Disease (CKD)
Behavioral: Information
Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)
  • Experimental: Information
    Participants randomized to this arm of the study will received the PREPARED educational book and video.
    Intervention: Behavioral: Information
  • 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.
    Intervention: Behavioral: Information
  • No Intervention: Usual Care
    Participants randomized to this arm of the study will receive usual care from their physician.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
210
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01439516
NA_00011846
1R01DK079682-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Leigh Ebony Boulware, Johns Hopkins University
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Leigh Ebony Boulware, MD Johns Hopkins University
Johns Hopkins University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP