Trial Outcomes & Findings for APOL1 Genetic Testing Program for Living Donors (NCT NCT04910867)
NCT ID: NCT04910867
Last Updated: 2026-09-02
Results Overview
The Decisional Conflict Scale will measure donor candidates' perceived uncertainty in decision-making about donating and satisfaction with effective decision-making. Scores range from: 0-100 Higher scores reflect greater decisional conflict (a worse outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Results posted on
2026-09-02
Participant Flow
Dates of recruitment period: September 2021-July 2025. Types of location: 2 kidney transplant programs at academic medical centers.
All of the data for the nephrologists in this study is reported separately in the record NCT04999436 APOL1 Genetic Testing Program for Living Donors, Part 2 R01 DK128207 part 2.
Participant milestones
| Measure |
Intervention Arm
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
Control Arm
No intervention will be administered. Usual care will be administered.
|
|---|---|---|
|
Pre-test period
STARTED
|
0
|
75
|
|
Pre-test period
COMPLETED
|
0
|
38
|
|
Pre-test period
NOT COMPLETED
|
0
|
37
|
|
Post-test period
STARTED
|
205
|
0
|
|
Post-test period
COMPLETED
|
49
|
0
|
|
Post-test period
NOT COMPLETED
|
156
|
0
|
Reasons for withdrawal
| Measure |
Intervention Arm
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
Control Arm
No intervention will be administered. Usual care will be administered.
|
|---|---|---|
|
Pre-test period
Lost to Follow-up
|
0
|
37
|
|
Post-test period
Lost to Follow-up
|
156
|
0
|
Baseline Characteristics
Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
Baseline characteristics by cohort
| Measure |
Control Arm
n=75 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=205 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.29 years
STANDARD_DEVIATION 12.65 • n=136 Participants
|
40.11 years
STANDARD_DEVIATION 12.94 • n=136 Participants
|
40.16 years
STANDARD_DEVIATION 12.84 • n=272 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
42 Participants
n=136 Participants
|
123 Participants
n=136 Participants
|
165 Participants
n=272 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
33 Participants
n=136 Participants
|
80 Participants
n=136 Participants
|
113 Participants
n=272 Participants
|
|
Sex/Gender, Customized
Sex · Other
|
0 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
2 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
2 Participants
n=272 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
0 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
0 Participants
n=272 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
0 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
0 Participants
n=272 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=136 Participants
|
185 Participants
n=136 Participants
|
252 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
57 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
167 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
224 Participants
n=272 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
|
Race (NIH/OMB)
White
|
3 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
4 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
7 Participants
n=272 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
25 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
35 Participants
n=272 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
7 Participants
n=136 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
12 Participants
n=272 Participants • Because potential living donors were able to select more than one race category, so had to reclassify participants into racial groups: participants who self-reported as "Multi-racial" (by selecting different racial categories) or as "More than one race" are now combined into one category "More than one race". Thus, the numbers presented below look a little different from Table 1 in the CJASN 2026 publication of the trial results.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=136 Participants
|
18 Participants
n=136 Participants
|
26 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=136 Participants
|
205 participants
n=136 Participants
|
280 participants
n=272 Participants
|
PRIMARY outcome
Timeframe: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)Population: Potential living kidney donors of African ancestry initiating evaluation for living kidney donation. The intervention arm had up to 4 time points of data collection (T1, T2, T3, T4). The control arm had up to 2 time points of data collection (T1, T4). Many participants were lost to follow up between T1 and T4 so there are fewer participants analyzed with each visit
The Decisional Conflict Scale will measure donor candidates' perceived uncertainty in decision-making about donating and satisfaction with effective decision-making. Scores range from: 0-100 Higher scores reflect greater decisional conflict (a worse outcome).
Outcome measures
| Measure |
Control Arm
n=75 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=203 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
|---|---|---|
|
Decisional Conflict Scale (DCS) (4 Time Points)
Baseline (T1)
|
16.35 score on a scale
Standard Deviation 15.13
|
14.38 score on a scale
Standard Deviation 13.62
|
|
Decisional Conflict Scale (DCS) (4 Time Points)
T2
|
—
|
13.50 score on a scale
Standard Deviation 13.96
|
|
Decisional Conflict Scale (DCS) (4 Time Points)
T3
|
—
|
11.78 score on a scale
Standard Deviation 15.66
|
|
Decisional Conflict Scale (DCS) (4 Time Points)
T4
|
10.73 score on a scale
Standard Deviation 10.83
|
12.05 score on a scale
Standard Deviation 13.35
|
SECONDARY outcome
Timeframe: T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)Population: Many potential living donors drop out of being evaluated, thus, they lose touch with the transplant program and researchers. Accordingly, there was loss to attrition. PDMS was collected from the Control arm at T4, and from the Intervention arm at T2, T3, T4 so there is only data for those visits
The Preparation for Decision Making Scale is a process measure that will assess donor candidates' perception of how useful the decision support intervention is in preparing them to communicate with their physician and make the donation about donating. Scores range from: 0-100 Higher scores indicate higher perceived level of preparation for decision making PDMS was collected from the Control arm at T4, and from the Intervention arm at T2, T3, T4.
Outcome measures
| Measure |
Control Arm
n=37 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=147 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
|---|---|---|
|
Preparation for Decision Making Scale (PDMS) (Collected up to 3 Times) Scores Range From: Higher Scores Reflect Greater Preparation for Decision Making (a Better Outcome)
T4
|
78.11 score on a scale
Standard Deviation 24.49
|
69.93 score on a scale
Standard Deviation 27.01
|
|
Preparation for Decision Making Scale (PDMS) (Collected up to 3 Times) Scores Range From: Higher Scores Reflect Greater Preparation for Decision Making (a Better Outcome)
T2
|
—
|
77.77 score on a scale
Standard Deviation 22.90
|
|
Preparation for Decision Making Scale (PDMS) (Collected up to 3 Times) Scores Range From: Higher Scores Reflect Greater Preparation for Decision Making (a Better Outcome)
T3
|
—
|
72.97 score on a scale
Standard Deviation 26.97
|
SECONDARY outcome
Timeframe: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)Population: Many potential living donors drop out of being evaluated, thus, they lose touch with the transplant program and researchers. Accordingly, there was loss to attrition between time points. Willingness was assessed at T1 and T4 for the control arm, an at T1, T2, T3, T4 for the intervention arm so data is reported for only T1 and T4 visits for the control arm
This scale will assess how willing donor candidates are to donate. Scores range from 1-10 Higher scores reflect greater willingness to donate Willingness was assessed at T1 and T4 for the control arm, an at T1, T2, T3, T4 for the intervention arm.
Outcome measures
| Measure |
Control Arm
n=75 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=201 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
|---|---|---|
|
Willingness to Donate (2-4 Time Points) Scores Range From: 0 to 10. Higher Scores Reflect Greater Willingness to Donate.
T1
|
8.88 score on a scale
Standard Deviation 1.90
|
9.06 score on a scale
Standard Deviation 1.50
|
|
Willingness to Donate (2-4 Time Points) Scores Range From: 0 to 10. Higher Scores Reflect Greater Willingness to Donate.
T2
|
—
|
9.07 score on a scale
Standard Deviation 1.68
|
|
Willingness to Donate (2-4 Time Points) Scores Range From: 0 to 10. Higher Scores Reflect Greater Willingness to Donate.
T3
|
—
|
8.47 score on a scale
Standard Deviation 2.81
|
|
Willingness to Donate (2-4 Time Points) Scores Range From: 0 to 10. Higher Scores Reflect Greater Willingness to Donate.
T4
|
8.11 score on a scale
Standard Deviation 3.40
|
8.29 score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)Population: Due to attrition and potential donors no longer wishing to undergo evaluation to be a donor, the numbers of participants completing the surveys at different time points varies.
This refers to donor candidates' satisfaction with the quality of decision-making. Scores range from: 1 - 5 Higher scores reflect greater satisfaction with the informed consent process This measure was assessed one time for the control arm (T4) and two times for the intervention arm (T3, T4).
Outcome measures
| Measure |
Control Arm
n=38 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=74 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
|---|---|---|
|
Satisfaction With the Informed Consent Process - Quality of Decision-Making (2 Time Points)
T3
|
—
|
4.51 score on a scale
Standard Deviation 0.61
|
|
Satisfaction With the Informed Consent Process - Quality of Decision-Making (2 Time Points)
T4
|
4.46 score on a scale
Standard Deviation 0.68
|
4.45 score on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)Population: Due to attrition and potential donors no longer wishing to undergo evaluation to be a donor, the numbers of participants completing the surveys at different time points varies.
This refers to donor candidates' satisfaction with the decision. Scores range from: 1 - 5 Higher scores reflect greater satisfaction with the informed consent process The control arm completed this measure one time at T4, and the intervention arm completed this measure two times, at T3 and T4.
Outcome measures
| Measure |
Control Arm
n=38 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=75 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
|---|---|---|
|
Satisfaction With the Informed Consent Process - Satisfaction With the Decision (2 Time Points)
T3
|
—
|
3.68 score on a scale
Standard Deviation 0.47
|
|
Satisfaction With the Informed Consent Process - Satisfaction With the Decision (2 Time Points)
T4
|
3.56 score on a scale
Standard Deviation 0.51
|
3.57 score on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)Population: Due to attrition and potential donors no longer wishing to undergo evaluation to be a donor, the numbers of participants completing the surveys at different time points varies.
This refers to donor candidates' decision-making quality, decision satisfaction, and perception of information. Scores range from: 1 - 5 Higher scores reflect greater satisfaction with the informed consent process The control arm completed this measure one time at T4, and the intervention arm completed this measure two times, at T3 and T4.
Outcome measures
| Measure |
Control Arm
n=38 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=74 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
|---|---|---|
|
Satisfaction With the Informed Consent Process - Right Amount of Information Had Been Provided to Make a Decision (2 Time Points)
T3
|
—
|
4.46 score on a scale
Standard Deviation 0.67
|
|
Satisfaction With the Informed Consent Process - Right Amount of Information Had Been Provided to Make a Decision (2 Time Points)
T4
|
4.60 score on a scale
Standard Deviation 0.49
|
4.33 score on a scale
Standard Deviation 0.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)Population: Many potential living donors drop out of being evaluated, thus, they lose touch with the transplant program and researchers. Accordingly, there was loss to attrition between time points. Preparedness to donate was assessed at T1 and T4 for the control arm, an at T1, T2, T3, T4 for the intervention arm so data is reported for only T1 and T4 visits for the control arm
Preparedness to donate was assessed on a 10 point Likert scale (1-10) Higher scores mean greater preparedness to donate Due to attrition and potential donors no longer wishing to undergo evaluation to be a donor, the numbers of participants completing the surveys at different time points varies.
Outcome measures
| Measure |
Control Arm
n=75 Participants
No intervention will be administered. Usual care will be administered.
|
Intervention Arm
n=202 Participants
APOL1 testing program
Components of Genetic Counseling: The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testing: APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integration: APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
|
|---|---|---|
|
Preparedness to Donate (Likert Scale) (2-4 Time Points)
T1
|
8.04 score on a scale
Standard Deviation 2.10
|
8.00 score on a scale
Standard Deviation 2.10
|
|
Preparedness to Donate (Likert Scale) (2-4 Time Points)
T2
|
—
|
8.18 score on a scale
Standard Deviation 2.16
|
|
Preparedness to Donate (Likert Scale) (2-4 Time Points)
T3
|
—
|
8.12 score on a scale
Standard Deviation 2.69
|
|
Preparedness to Donate (Likert Scale) (2-4 Time Points)
T4
|
7.87 score on a scale
Standard Deviation 3.03
|
8.14 score on a scale
Standard Deviation 2.78
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elisa J. Gordon
Vanderbilt University Medical Center
Phone: 708-646-7973
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place