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Reducing Disparities in Living Donor Transplant Among African Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819686
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : January 28, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Rachel Patzer, PhD, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Behavioral: Living ACTS website Behavioral: Standard transplant education procedures Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Disparities in Living Donor Transplant Among African Americans
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Living ACTS website
In addition to the provision of standard transplant education procedures, 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 the 20-minute video).
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)

Behavioral: 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.

Standard transplant education procedures
Usual Care, which involves the provision of standard transplant education procedures at each transplant center, which entail reviewing 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in percent of patients with at least one inquiry from a potential living donor [ Time Frame: Baseline, 12 months ]
    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.


Secondary Outcome Measures :
  1. Change in knowledge and understanding of donation/transplantation assessment score [ Time Frame: Baseline, 12 months ]
    Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-12 Maximum

  2. Change in motivation scale score to ask a family member to be a living donor [ Time Frame: Baseline, 12 months ]
    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.

  3. Change in confidence in initiating a conversation about LDKT [ Time Frame: Baseline, 12 months ]
    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.


Other Outcome Measures:
  1. Comprehensive and final list of website modifications. [ Time Frame: 12 months post-baseline ]
    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.

  2. Change in intention to discuss LDKT with family members [ Time Frame: Baseline, 12 months ]
    1-item behavioral intentions scale measures intention to discuss LDKT with family members, score ranges 1-5 (1-extremely unlikely, 5 - extremely likely)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 65 years
  • BMI < 35
  • English-speaking

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): NCT03819686


Locations
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United States, Georgia
Emory Transplant Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Rachel Patzer, PhD, MPH, FAST Emory University
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Responsible Party: Rachel Patzer, PhD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03819686    
Other Study ID Numbers: IRB00098952
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Patzer, PhD, Emory University:
end stage renal disease
ESRD
living donor kidney transplantation
LDKT
African American