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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK114891 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Living ACTS website | Experimental | 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). |
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| Standard transplant education procedures | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Living ACTS website | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Day 1 immediately post-intervention |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Jacob Arriola, PhD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Transplant Center | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39698959 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants analyzed included patients that completed the visit for each time point. | Posted | Number | percentage of participants | Baseline, 12 months |
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Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kimberly Jacob Arriola | Emory University | 404)-727-2600 | kjacoba@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2020 | Jan 23, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2023 | Apr 27, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Standard transplant education procedures | Behavioral | 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. |
|
| 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. |
| Baseline, Day 1 immediately post-intervention |
| 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. | Baseline, Day 1 immediately post-intervention |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. 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. |
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| Secondary | 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). | Number of participants analyzed included patients that completed the visit for each time point for the purpose of collecting data for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 immediately post-intervention |
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| Secondary | 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. | Number of participants analyzed included patients that completed the visit for each time point for the purpose of collecting data for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 immediately post-intervention |
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| Secondary | 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. | Number of participants analyzed included patients that completed the visit for each time point for the purpose of collecting data for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 immediately post-intervention |
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|
|
| 0 |
| 224 |
| 0 |
| 224 |
| 0 |
| 224 |
| EG001 | 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. 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. | 0 | 192 | 0 | 192 | 0 | 192 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Knowledge assessment score at average 12 months post-intervention |
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| Motivation scale score at average 12 months post-intervention |
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| Behavioral skills scale score at average 12 months post-baseline |
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