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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
259 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
41 Participants
n=157 Participants
|
|
Age, Continuous
|
51.7 years
n=99 Participants
|
52.3 years
n=107 Participants
|
52.4 years
n=206 Participants
|
52.3 years
n=157 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
133 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
167 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
300 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
300 Participants
n=157 Participants
|
|
Education
Intermediate or middle school (6-8)
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Education
High school (9-12) or GED
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
113 Participants
n=157 Participants
|
|
Education
Two years of college
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
93 Participants
n=157 Participants
|
|
Education
College
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
65 Participants
n=157 Participants
|
|
Education
Graduate or professional school
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
|
Employment
Full-time employee
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
59 Participants
n=157 Participants
|
|
Employment
Part-time employee
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
21 Participants
n=157 Participants
|
|
Employment
Student
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Employment
Retired
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
33 Participants
n=157 Participants
|
|
Employment
Homemaker
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
|
Employment
Retired due to disability
|
56 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
151 Participants
n=157 Participants
|
|
Employment
Unemployed/looking for work
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
|
Employment
Refused
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Income
Under $20,000
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
58 Participants
n=157 Participants
|
|
Income
$20,000 - $39,999
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
70 Participants
n=157 Participants
|
|
Income
$40,000 - $59,999
|
26 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
60 Participants
n=157 Participants
|
|
Income
$60,000 or more
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
67 Participants
n=157 Participants
|
|
Income
Refused/Don't know
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
45 Participants
n=157 Participants
|
|
Poverty
Not in poverty
|
70 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
202 Participants
n=157 Participants
|
|
Poverty
Near poverty
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
|
Poverty
Poverty
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
29 Participants
n=157 Participants
|
|
Poverty
Missing
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
45 Participants
n=157 Participants
|
|
Medical Insurance
Private
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
68 Participants
n=157 Participants
|
|
Medical Insurance
Medicaid Only
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
Medical Insurance
Medicare Only
|
57 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
158 Participants
n=157 Participants
|
|
Medical Insurance
Medicare/Medicaid
|
14 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
57 Participants
n=157 Participants
|
|
Medical Insurance
Other
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Marital status
Married/living with partner
|
48 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
136 Participants
n=157 Participants
|
|
Marital status
Separated
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
|
Marital status
Divorced
|
18 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
40 Participants
n=157 Participants
|
|
Marital status
Single, never married
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
89 Participants
n=157 Participants
|
|
Marital status
Widowed
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
17 Participants
n=157 Participants
|
|
Family members
Has child(ren) · Yes
|
77 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
240 Participants
n=157 Participants
|
|
Family members
Has child(ren) · No
|
23 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
60 Participants
n=157 Participants
|
|
Family members
Has sibling(s) · Yes
|
86 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
268 Participants
n=157 Participants
|
|
Family members
Has sibling(s) · No
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
32 Participants
n=157 Participants
|
|
Family members
Mother living · Yes
|
43 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
148 Participants
n=157 Participants
|
|
Family members
Mother living · No
|
57 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
152 Participants
n=157 Participants
|
|
Family members
Father living · Yes
|
35 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
89 Participants
n=157 Participants
|
|
Family members
Father living · No
|
65 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
211 Participants
n=157 Participants
|
|
Total potential immediate family donors
|
6 potential immediate family donors
n=99 Participants
|
6 potential immediate family donors
n=107 Participants
|
5.5 potential immediate family donors
n=206 Participants
|
6 potential immediate family donors
n=157 Participants
|
|
Family history of kidney disease
|
52 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
152 Participants
n=157 Participants
|
|
Health literacy
≤3rd grade
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Health literacy
4th-6th grade
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
Health literacy
7th-8th grade
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
89 Participants
n=157 Participants
|
|
Health literacy
≥9th grade
|
64 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
177 Participants
n=157 Participants
|
|
Health literacy
Missing
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Years on the waiting list
|
0.5 years
n=99 Participants
|
0.8 years
n=107 Participants
|
0.9 years
n=206 Participants
|
0.8 years
n=157 Participants
|
|
Current end-stage (ESRD) renal disease treatment
No kidney replacement treatment yet
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
|
Current end-stage (ESRD) renal disease treatment
In-center hemodialysis
|
63 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
189 Participants
n=157 Participants
|
|
Current end-stage (ESRD) renal disease treatment
Home hemodialysis
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
|
Current end-stage (ESRD) renal disease treatment
Peritoneal dialysis
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
46 Participants
n=157 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
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
Moderate (Discussed with family)
|
12 Participants
|
10 Participants
|
8 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