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

Chronic Kidney Disease (CKD) Clinical Trial

— PREPARED  

Official title:

Information and Financial Interventions for Kidney Donation in African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439516
• Other study ID #: NA_00011846
• Secondary ID: 1R01DK079682-01
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• End Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Information
Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pursuit of Living Related Transplantation	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.	6 months