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Kidney TransplantNCT03819686

Reducing Disparities in Living Donor Transplant Among African Americans

A study testing Living ACTS website and Standard transplant education procedures in people with Kidney Transplant, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Kidney Transplant
What is being tested?
Living ACTS website and Standard transplant education procedures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
1 siteUnited States
Study dates
4 Feb 2019to 26 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory Transplant Center

    Atlanta, Georgia, 30322

Other trials in United States

About this study

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.

Read the 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.

Being tested
Living ACTS website, Standard transplant education procedures
Keywords
end stage renal disease, ESRD, living donor kidney transplantation, LDKT, African American
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Living ACTS websiteBehavioural

    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 proceduresBehavioural

    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.

Study groups in NCT03819686
Study groupRoleWhat they receive
Living ACTS websiteExperimentalIn 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).
Receives: Behavioral: Living ACTS website; Behavioral: Standard transplant education procedures
Standard transplant education proceduresOtherUsual 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.
Receives: Behavioral: Standard transplant education procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12 months

Secondary outcomes (3)

  1. Knowledge and Understanding of Donation/Transplantation Assessment Score

    Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-13 Maximum where higher scores indicate greater knowledge (i.e., participants receive 1 point for each correct answer).

    Measured: Baseline, Day 1 immediately post-intervention

  2. 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, Possible score range from 9 to 45 with higher values indicating stronger agreement with the statement.

    Measured: Baseline, Day 1 immediately post-intervention

  3. 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, total possible score range is 10-50, with higher values indicate stronger confidence.

    Measured: Baseline, Day 1 immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2019
  2. Study start4 Feb 2019
  3. Primary completion26 Jan 2024
  4. Study completion26 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03819686
Sponsor's protocol ID
IRB00098952
Other IDs
R01DK114891
Status last verified
Mar 2025
First submitted
25 Jan 2019
Last updated
24 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arriola KJ, Barrett D, Pastan S, Perryman J, DuBay D, Tresslar C, De Abreu SU, Di M, Teunis L, Montoya M, Mangurenje T, Patzer RE. Immediate Postintervention Outcomes from a Randomized Trial that Sought to Enhance Access to Live Donor Kidney Transplant for Black and African Americans. Prog Transplant. 2025 Mar;35(1):5-12. doi: 10.1177/15269248241304794. Epub 2024 Dec 19.

    PubMed 39698959

Questions about this trial

What is this clinical trial studying?

A study testing Living ACTS website and Standard transplant education procedures in people with Kidney Transplant, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Patients With at Least One Inquiry From a Potential Living Donor (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03819686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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