Trial Outcomes & Findings for Transplant Social Worker Support for Live Kidney Donation in African Americans (NCT NCT02369354)
NCT ID: NCT02369354
Last Updated: 2023-07-05
Results Overview
Composite rate of live kidney donor inquiries on behalf of participants, completed live kidney donor transplant evaluations, and live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
24 months post randomization
Results posted on
2023-07-05
Participant Flow
Recruitment occurred between September 2015 and May 2017. Participants were recruited from the Duke University Kidney and Pancreas Transplant Center in Durham, North Carolina. Transplant Center electronic health records were used to identify eligible patients.
Family members or friends of potential kidney transplant recipients and potential live kidney donors were not enrolled in the study.
Participant milestones
| Measure |
Usual Care
Usual medical care at the Duke Kidney Transplant Clinic
|
TALKS
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
|
TALKS PLUS
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
Financial Assistance Intervention: The financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
88
|
86
|
86
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transplant Social Worker Support for Live Kidney Donation in African Americans
Baseline characteristics by cohort
| Measure |
Usual Care
n=100 Participants
Usual medical care at the Duke Kidney Transplant Clinic
|
TALKS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
|
TALKS PLUS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
Financial Assistance Intervention: The financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Continuous
|
51.7 years
n=5 Participants
|
52.3 years
n=7 Participants
|
52.4 years
n=5 Participants
|
52.3 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Education
Intermediate or middle school (6-8)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Education
High school (9-12) or GED
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Education
Two years of college
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Education
College
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Education
Graduate or professional school
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Employment
Full-time employee
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Employment
Part-time employee
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Employment
Student
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Employment
Retired
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Employment
Homemaker
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Employment
Retired due to disability
|
56 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Employment
Unemployed/looking for work
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Employment
Refused
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Income
Under $20,000
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Income
$20,000 - $39,999
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Income
$40,000 - $59,999
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Income
$60,000 or more
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Income
Refused/Don't know
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Poverty
Not in poverty
|
70 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Poverty
Near poverty
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Poverty
Poverty
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Poverty
Missing
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Medical Insurance
Private
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Medical Insurance
Medicaid Only
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Medical Insurance
Medicare Only
|
57 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Medical Insurance
Medicare/Medicaid
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Medical Insurance
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Marital status
Married/living with partner
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Marital status
Separated
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Marital status
Divorced
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Marital status
Single, never married
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Marital status
Widowed
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Family members
Has child(ren) · Yes
|
77 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
240 Participants
n=4 Participants
|
|
Family members
Has child(ren) · No
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Family members
Has sibling(s) · Yes
|
86 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
268 Participants
n=4 Participants
|
|
Family members
Has sibling(s) · No
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Family members
Mother living · Yes
|
43 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Family members
Mother living · No
|
57 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Family members
Father living · Yes
|
35 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Family members
Father living · No
|
65 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Total potential immediate family donors
|
6 potential immediate family donors
n=5 Participants
|
6 potential immediate family donors
n=7 Participants
|
5.5 potential immediate family donors
n=5 Participants
|
6 potential immediate family donors
n=4 Participants
|
|
Family history of kidney disease
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Health literacy
≤3rd grade
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Health literacy
4th-6th grade
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Health literacy
7th-8th grade
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Health literacy
≥9th grade
|
64 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Health literacy
Missing
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Years on the waiting list
|
0.5 years
n=5 Participants
|
0.8 years
n=7 Participants
|
0.9 years
n=5 Participants
|
0.8 years
n=4 Participants
|
|
Current end-stage (ESRD) renal disease treatment
No kidney replacement treatment yet
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Current end-stage (ESRD) renal disease treatment
In-center hemodialysis
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Current end-stage (ESRD) renal disease treatment
Home hemodialysis
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Current end-stage (ESRD) renal disease treatment
Peritoneal dialysis
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 months post randomizationComposite rate of live kidney donor inquiries on behalf of participants, completed live kidney donor transplant evaluations, and live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual medical care at the Duke Kidney Transplant Clinic
|
TALKS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
|
TALKS PLUS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
Financial Assistance Intervention: The financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
|
|---|---|---|---|
|
Number of Participants With Live Kidney Donor Activation Events
0 Activation events
|
87 Participants
|
86 Participants
|
88 Participants
|
|
Number of Participants With Live Kidney Donor Activation Events
1 Activation event
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Live Kidney Donor Activation Events
2 Activation events
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Live Kidney Donor Activation Events
3 Activation events
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Live Kidney Donor Activation Events
4 Activation events
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Live Kidney Donor Activation Events
>=5 Activation events
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 months post randomizationPotential kidney recipients' behaviors reflecting their interest and pursuit of live donor kidney transplantation, including: self-reported live donor kidney transplant discussions with physicians, self-reported live donor kidney transplant discussions with family, and identification of a potential live donor.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual medical care at the Duke Kidney Transplant Clinic
|
TALKS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
|
TALKS PLUS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
Financial Assistance Intervention: The financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
|
|---|---|---|---|
|
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
Moderate (Discussed with family)
|
12 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
Low pursuit (did not discuss with family)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
High (Identified potential donor)
|
58 Participants
|
57 Participants
|
64 Participants
|
|
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
Data missing
|
29 Participants
|
33 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 24 months post randomizationPassive follow up of participants for 2 years to assess completed live kidney donor transplant evaluations in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual medical care at the Duke Kidney Transplant Clinic
|
TALKS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
|
TALKS PLUS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
Financial Assistance Intervention: The financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
|
|---|---|---|---|
|
Number of Participants With Live Donor Evaluations
0 Evaluations
|
93 Participants
|
93 Participants
|
97 Participants
|
|
Number of Participants With Live Donor Evaluations
1 Evaluation
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Live Donor Evaluations
2 Evaluations
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Live Donor Evaluations
3 Evaluations
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Live Donor Evaluations
4 Evaluations
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 months post randomizationPassive follow up of participants for 2 years to assess live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
Outcome measures
| Measure |
Usual Care
n=100 Participants
Usual medical care at the Duke Kidney Transplant Clinic
|
TALKS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
|
TALKS PLUS
n=100 Participants
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
Financial Assistance Intervention: The financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
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Number of Participants With Live Kidney Donor Transplants
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2 Participants
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1 Participants
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2 Participants
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Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TALKS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TALKS PLUS
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. L. Ebony Boulware
Duke University School of Medicine
Phone: 919-613-2099
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place