Reducing Disparities in Living Donor Transplant Among African Americans

Kidney Transplant Clinical Trial

Official title:

Reducing Disparities in Living Donor Transplant Among African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819686
• Other study ID #: IRB00098952
• Secondary ID: R01DK114891
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: January 26, 2024

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment, and living donor kidney transplantation (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over study period.The long-term objective is to understand the combined effect of a systems-level intervention (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

Description:

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment. Moreover, living donor kidney transplantation (LDKT) offers numerous advantages such as better kidney quality, increased short- and long-term graft survival, lower rates of acute rejection, and reduced health care cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD patients four times more likely to receive a LDKT than African American ESRD patients. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over 12 months from baseline.The long-term objective is to understand the combined effect of a systems-level intervention that enhances communication between dialysis facility and transplant center clinicians (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• All patients referred (from dialysis facility, chronic kidney disease clinic, or self) and scheduled for an evaluation at one of the four study sites within the study time period.

• African American or Black

• age 18 to 70 years

• BMI < 39

• English-speaking

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Behavioral:
• Living ACTS website
Living ACTS: About Choices in Transplantation and Sharing video that draws from the Information-Motivation-Behavioral Skills Model of individual level behavior change. A patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching ~20-minutes of videos from the website)
• Standard transplant education procedures
Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two ~10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.

Locations

Country	Name	City	State
United States	Emory Transplant Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory 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
Other	Comprehensive and final list of website modifications.	A series of individual interviews with participants will be conducted to obtain feedback on the web-based version of Living ACTS. All facilitators will meet to compare findings and to compose a comprehensive and final list of website modifications. Participant feedback will be used to refine and finalize the web-based intervention.	12 months post-baseline
Other	Change in intention to discuss LDKT with family members	1-item behavioral intentions scale measures intention to discuss LDKT with family members, score ranges 1-5 (1-extremely unlikely, 5 - extremely likely)	Baseline, 12 months
Primary	Change in percent of patients with at least one inquiry from a potential living donor	Data collection form that captures potential recipient ID (i.e. study participant), date of living donor inquiry, and donor inquiry ID, will be securely obtained from each transplant center following a 12 month period from enrollment. Data will be collected electronically for all study participants through a secure, HIPAA-compliant data server (QualityNet). The percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS will be compared to those who receive a control website with embedded educational video.	Baseline, 12 months
Secondary	Change in knowledge and understanding of donation/transplantation assessment score	Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-12 Maximum	Baseline, 12 months
Secondary	Change in motivation scale score to ask a family member to be a living donor	9-item scale assesses motivation to ask a family member to be a living donor. Potential responses range from 1 to 5 with higher values indicate stronger agreement with the statement.	Baseline, 12 months
Secondary	Change in confidence in initiating a conversation about LDKT	10-item behavioral skills scale measures confidence in initiating a conversation about LDKT. Potential responses range from 1 to 5 with higher values indicate stronger confidence.	Baseline, 12 months