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

NCT01439516 | Completed DMC

• 2 other identifiers: NA_000118461R01DK079682-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease (ESRD); Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Information

EXPERIMENTAL

Participants randomized to this arm of the study will received the PREPARED educational book and video.

Behavioral: Information

Information and Financial Assistance

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Participants randomized to this arm of the study will receive usual care from their physician.

Interventions

Information BEHAVIORAL

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

Information; Information and Financial Assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Boulware LE, Ephraim PL, Ameling J, Lewis-Boyer L, Rabb H, Greer RC, Crews DC, Jaar BG, Auguste P, Purnell TS, Lamprea-Monteleagre JA, Olufade T, Gimenez L, Cook C, Campbell T, Woodall A, Ramamurthi H, Davenport CA, Choudhury KR, Weir MR, Hanes DS, Wang NY, Vilme H, Powe NR. Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients. BMC Nephrol. 2018 May 3;19(1):107. doi: 10.1186/s12882-018-0901-x.

  PMID: 29724177 DERIVED

• Ephraim PL, Powe NR, Rabb H, Ameling J, Auguste P, Lewis-Boyer L, Greer RC, Crews DC, Purnell TS, Jaar BG, DePasquale N, Boulware LE. The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial. BMC Nephrol. 2012 Oct 12;13:135. doi: 10.1186/1471-2369-13-135.

  PMID: 23057616 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leigh Ebony Boulware, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 23, 2011
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

US (1)