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Transplant Social Worker Support for Live Kidney Donation in African Americans

Transplant Social Worker Support for Live Kidney Donation in African Americans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02369354
Acronym
TALKS
Enrollment
300
Registered
2015-02-23
Start date
2015-09-30
Completion date
2019-07-02
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease

Keywords

Kidney Transplant, African Americans

Brief summary

Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education, behavior, and financial support interventions to improve consideration of live kidney transplantation/live kidney donation among African Americans on the deceased kidney waiting list. We hypothesize that interventions to help potential kidney transplant recipients and their potential donors overcome barriers to live donor kidney transplant (including family discussions, financial, or logistical barriers) could improve potential recipients' receipt of live kidney transplants. The main outcomes of TALKS will include whether potential recipients (1) have potential live donors call into the transplant center on their behalf; (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney transplant.

Detailed description

Live donor kidney transplantation (LDKT) represents an optimal therapy for many patients. However, African Americans have been persistently and significantly less likely to receive LDKT when compared to Whites. The process of seeking and establishing a live donor for LDKT requires potential donors overcome several potential obstacles to LKDT. As a critical first step to seeking LDKT, patients must engage their physicians and their family members or friends (who provide support for patients' health decisions and could also be potential donors) in discussions about LDKT to determine whether LDKT is a viable and/or desirable treatment option. LDKT discussions with physicians help patients and family members understand the risks and benefits of LDKT to both the potential recipient and any potential donors. Families' LDKT discussions help them establish whether it is possible to identify willing and medically eligible live donors, and they help families discuss the potential psychological, physical, and financial strains of LDKT on patients and families. Once discussions have occurred, potential donors must confront logistical (e.g., childcare or travel to transplant centers) and financial (e.g., unpaid time away from work) challenges associated with LDKT. Studies have shown that even when African American patients desire LDKT, rates of LDKT discussions are suboptimal. Further, African American potential live kidney donors are less likely than their White counterparts to complete the donor evaluation process, and they may be more sensitive than Whites to logistical and financial barriers to LDKT. Innovative strategies to overcome interpersonal, logistical and financial barriers to LDKT are sorely needed for African Americans, particularly those who may be highly motivated to seek this therapy. Transplant social workers routinely perform psychosocial evaluations on potential LDKT recipients and donors and are well suited to support families' navigation of LDKT discussions. Transplant social workers are also well versed in the financial aspects of LDKT (e.g., insurance coverage rules) and frequently provide financial guidance to potential LDKT recipients and donors. We will study innovative transplant social worker led interventions designed to help African American potential LDKT recipients and their families overcome interpersonal, logistical and financial barriers to LDKT. African Americans on the deceased kidney donor waiting list will be randomly assigned to (1) receive their usual care on the transplant list or (2) to one of two social worker led interventions-one which helps patients and families discuss LDKT with each other and with patients' physicians, and one which provides families with financial support to overcome logistical and financial barriers to LDKT. As a primary outcome, we will measure whether the interventions activate live kidney donation on African American potential recipients' behalf.

Interventions

BEHAVIORALTALKS 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.

OTHERFinancial 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For potential kidney transplant recipients (all arms): Inclusion Criteria: * Adult (18 yrs or older) * African American * Duke Kidney and Pancreas Transplant patients with end stage kidney disease * Currently on the deceased donor kidney waiting list from the Duke Kidney and Pancreas Transplant Program * Give consent to participate

Exclusion criteria

* Previous kidney transplant (Revised Sept 2016: persons who have previously received a deceased donor kidney transplant, but who have not previously received a live donor kidney transplant) * Cognitively impaired/Change in cognition * Impaired hearing or speech * Non-English speaking For family members or friends of potential kidney transplant recipients (TALK and TALK PLUS arms): Inclusion Criteria: * 18 or older * Come to SWI meeting with patient * Give consent to participate For potential live kidney donors (TALKS PLUS arm only) Inclusion Criteria: * 18 or older * Contact the study * Give consent to participate

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Live Kidney Donor Activation Events24 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.

Secondary

MeasureTime frameDescription
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation24 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.
Number of Participants With Live Donor Evaluations24 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.
Number of Participants With Live Kidney Donor Transplants24 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Family members or friends of potential kidney transplant recipients and potential live kidney donors were not enrolled in the study.

Participants by arm

ArmCount
Usual Care
Usual medical care at the Duke Kidney Transplant Clinic
100
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.
100
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.
100
Total300

Baseline characteristics

CharacteristicTotalUsual CareTALKSTALKS PLUS
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
41 Participants11 Participants17 Participants13 Participants
Age, Categorical
Between 18 and 65 years
259 Participants89 Participants83 Participants87 Participants
Age, Continuous52.3 years51.7 years52.3 years52.4 years
Current end-stage (ESRD) renal disease treatment
Home hemodialysis
12 Participants6 Participants3 Participants3 Participants
Current end-stage (ESRD) renal disease treatment
In-center hemodialysis
189 Participants63 Participants63 Participants63 Participants
Current end-stage (ESRD) renal disease treatment
No kidney replacement treatment yet
53 Participants15 Participants16 Participants22 Participants
Current end-stage (ESRD) renal disease treatment
Peritoneal dialysis
46 Participants16 Participants18 Participants12 Participants
Education
College
65 Participants22 Participants25 Participants18 Participants
Education
Graduate or professional school
25 Participants10 Participants5 Participants10 Participants
Education
High school (9-12) or GED
113 Participants37 Participants38 Participants38 Participants
Education
Intermediate or middle school (6-8)
4 Participants1 Participants2 Participants1 Participants
Education
Two years of college
93 Participants30 Participants30 Participants33 Participants
Employment
Full-time employee
59 Participants18 Participants19 Participants22 Participants
Employment
Homemaker
8 Participants1 Participants3 Participants4 Participants
Employment
Part-time employee
21 Participants6 Participants10 Participants5 Participants
Employment
Refused
1 Participants1 Participants0 Participants0 Participants
Employment
Retired
33 Participants9 Participants14 Participants10 Participants
Employment
Retired due to disability
151 Participants56 Participants47 Participants48 Participants
Employment
Student
5 Participants3 Participants1 Participants1 Participants
Employment
Unemployed/looking for work
22 Participants6 Participants6 Participants10 Participants
Family history of kidney disease152 Participants52 Participants49 Participants51 Participants
Family members
Father living
No
211 Participants65 Participants77 Participants69 Participants
Family members
Father living
Yes
89 Participants35 Participants23 Participants31 Participants
Family members
Has child(ren)
No
60 Participants23 Participants15 Participants22 Participants
Family members
Has child(ren)
Yes
240 Participants77 Participants85 Participants78 Participants
Family members
Has sibling(s)
No
32 Participants14 Participants9 Participants9 Participants
Family members
Has sibling(s)
Yes
268 Participants86 Participants91 Participants91 Participants
Family members
Mother living
No
152 Participants57 Participants50 Participants45 Participants
Family members
Mother living
Yes
148 Participants43 Participants50 Participants55 Participants
Health literacy
≤3rd grade
10 Participants3 Participants3 Participants4 Participants
Health literacy
4th-6th grade
13 Participants5 Participants4 Participants4 Participants
Health literacy
7th-8th grade
89 Participants27 Participants29 Participants33 Participants
Health literacy
≥9th grade
177 Participants64 Participants58 Participants55 Participants
Health literacy
Missing
11 Participants1 Participants6 Participants4 Participants
Income
$20,000 - $39,999
70 Participants21 Participants24 Participants25 Participants
Income
$40,000 - $59,999
60 Participants26 Participants14 Participants20 Participants
Income
$60,000 or more
67 Participants22 Participants26 Participants19 Participants
Income
Refused/Don't know
45 Participants13 Participants18 Participants14 Participants
Income
Under $20,000
58 Participants18 Participants18 Participants22 Participants
Marital status
Divorced
40 Participants18 Participants8 Participants14 Participants
Marital status
Married/living with partner
136 Participants48 Participants44 Participants44 Participants
Marital status
Separated
18 Participants3 Participants7 Participants8 Participants
Marital status
Single, never married
89 Participants27 Participants29 Participants33 Participants
Marital status
Widowed
17 Participants4 Participants12 Participants1 Participants
Medical Insurance
Medicaid Only
13 Participants5 Participants2 Participants6 Participants
Medical Insurance
Medicare/Medicaid
57 Participants14 Participants21 Participants22 Participants
Medical Insurance
Medicare Only
158 Participants57 Participants53 Participants48 Participants
Medical Insurance
Other
4 Participants2 Participants1 Participants1 Participants
Medical Insurance
Private
68 Participants22 Participants23 Participants23 Participants
Poverty
Missing
45 Participants13 Participants18 Participants14 Participants
Poverty
Near poverty
24 Participants7 Participants9 Participants8 Participants
Poverty
Not in poverty
202 Participants70 Participants65 Participants67 Participants
Poverty
Poverty
29 Participants10 Participants8 Participants11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
300 Participants100 Participants100 Participants100 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
300 Participants100 Participants100 Participants100 Participants
Sex: Female, Male
Female
133 Participants41 Participants46 Participants46 Participants
Sex: Female, Male
Male
167 Participants59 Participants54 Participants54 Participants
Total potential immediate family donors6 potential immediate family donors6 potential immediate family donors6 potential immediate family donors5.5 potential immediate family donors
Years on the waiting list0.8 years0.5 years0.8 years0.9 years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1000 / 1000 / 100
other
Total, other adverse events
0 / 1000 / 1000 / 100
serious
Total, serious adverse events
0 / 1000 / 1000 / 100

Outcome results

Primary

Number of Participants With Live Kidney Donor Activation Events

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.

Time frame: 24 months post randomization

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Live Kidney Donor Activation Events0 Activation events87 Participants
Usual CareNumber of Participants With Live Kidney Donor Activation Events1 Activation event5 Participants
Usual CareNumber of Participants With Live Kidney Donor Activation Events2 Activation events3 Participants
Usual CareNumber of Participants With Live Kidney Donor Activation Events3 Activation events3 Participants
Usual CareNumber of Participants With Live Kidney Donor Activation Events4 Activation events1 Participants
Usual CareNumber of Participants With Live Kidney Donor Activation Events>=5 Activation events1 Participants
TALKSNumber of Participants With Live Kidney Donor Activation Events>=5 Activation events0 Participants
TALKSNumber of Participants With Live Kidney Donor Activation Events0 Activation events86 Participants
TALKSNumber of Participants With Live Kidney Donor Activation Events3 Activation events2 Participants
TALKSNumber of Participants With Live Kidney Donor Activation Events4 Activation events1 Participants
TALKSNumber of Participants With Live Kidney Donor Activation Events1 Activation event4 Participants
TALKSNumber of Participants With Live Kidney Donor Activation Events2 Activation events7 Participants
TALKS PLUSNumber of Participants With Live Kidney Donor Activation Events1 Activation event7 Participants
TALKS PLUSNumber of Participants With Live Kidney Donor Activation Events2 Activation events2 Participants
TALKS PLUSNumber of Participants With Live Kidney Donor Activation Events>=5 Activation events0 Participants
TALKS PLUSNumber of Participants With Live Kidney Donor Activation Events3 Activation events3 Participants
TALKS PLUSNumber of Participants With Live Kidney Donor Activation Events0 Activation events88 Participants
TALKS PLUSNumber of Participants With Live Kidney Donor Activation Events4 Activation events0 Participants
Secondary

Number of Participants With Live Donor Evaluations

Passive 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.

Time frame: 24 months post randomization

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Live Donor Evaluations3 Evaluations0 Participants
Usual CareNumber of Participants With Live Donor Evaluations2 Evaluations2 Participants
Usual CareNumber of Participants With Live Donor Evaluations0 Evaluations93 Participants
Usual CareNumber of Participants With Live Donor Evaluations1 Evaluation5 Participants
Usual CareNumber of Participants With Live Donor Evaluations4 Evaluations0 Participants
TALKSNumber of Participants With Live Donor Evaluations2 Evaluations0 Participants
TALKSNumber of Participants With Live Donor Evaluations0 Evaluations93 Participants
TALKSNumber of Participants With Live Donor Evaluations1 Evaluation7 Participants
TALKSNumber of Participants With Live Donor Evaluations3 Evaluations0 Participants
TALKSNumber of Participants With Live Donor Evaluations4 Evaluations0 Participants
TALKS PLUSNumber of Participants With Live Donor Evaluations4 Evaluations0 Participants
TALKS PLUSNumber of Participants With Live Donor Evaluations3 Evaluations0 Participants
TALKS PLUSNumber of Participants With Live Donor Evaluations0 Evaluations97 Participants
TALKS PLUSNumber of Participants With Live Donor Evaluations2 Evaluations0 Participants
TALKS PLUSNumber of Participants With Live Donor Evaluations1 Evaluation3 Participants
Secondary

Number of Participants With Live Kidney Donor Transplants

Passive 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.

Time frame: 24 months post randomization

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Live Kidney Donor Transplants2 Participants
TALKSNumber of Participants With Live Kidney Donor Transplants1 Participants
TALKS PLUSNumber of Participants With Live Kidney Donor Transplants2 Participants
Secondary

Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation

Potential 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.

Time frame: 24 months post randomization

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationLow pursuit (did not discuss with family)1 Participants
Usual CareNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationModerate (Discussed with family)12 Participants
Usual CareNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationHigh (Identified potential donor)58 Participants
Usual CareNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationData missing29 Participants
TALKSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationData missing33 Participants
TALKSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationLow pursuit (did not discuss with family)0 Participants
TALKSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationHigh (Identified potential donor)57 Participants
TALKSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationModerate (Discussed with family)10 Participants
TALKS PLUSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationData missing27 Participants
TALKS PLUSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationModerate (Discussed with family)8 Participants
TALKS PLUSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationHigh (Identified potential donor)64 Participants
TALKS PLUSNumber of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney TransplantationLow pursuit (did not discuss with family)1 Participants

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026