Kidney DiseaseTALKSNCT02369354
Transplant Social Worker Support for Live Kidney Donation in African Americans
A study testing TALKS Social Worker Intervention and Financial Assistance Intervention in people with Kidney Disease, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease
- What is being tested?
- TALKS Social Worker Intervention and Financial Assistance Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 2 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 18 or older
Show all 12Show fewer
- Come to SWI meeting with patient
- Give consent to participate
- For potential live kidney donors (TALKS PLUS arm only)
- 18 or older
- Contact the study
- Give consent to participate
Who cannot join
- 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):
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke School of Medicine, Division of General Internal Medicine
Durham, North Carolina, 27701
About this study
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.
Read the 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.
- Conditions
- Kidney Disease
- Being tested
- TALKS Social Worker Intervention, Financial Assistance Intervention
- Keywords
- Kidney Transplant, African Americans
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TALKS Social Worker InterventionBehavioural
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 InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual medical care at the Duke Kidney Transplant Clinic |
| TALKS | Other | Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings Receives: Behavioral: TALKS Social Worker Intervention |
| TALKS PLUS | Other | Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention Receives: Behavioral: TALKS Social Worker Intervention; Other: Financial Assistance Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post randomization
Secondary outcomes (3)
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.
Measured: 24 months post randomization
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.
Measured: 24 months post randomization
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.
Measured: 24 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startSep 2015
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh E Boulware, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369354
- Sponsor's protocol ID
- Pro00052724
- Other IDs
- 1R01DK098759
- Acronym
- TALKS
- Status last verified
- Jun 2023
- First submitted
- 17 Feb 2015
- Last updated
- 5 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Boulware LE, Sudan DL, Strigo TS, Ephraim PL, Davenport CA, Pendergast JF, Pounds I, Riley JA, Falkovic M, Alkon A, Hill-Briggs F, Cabacungan AN, Barrett TM, Mohottige D, McElroy L, Diamantidis CJ, Ellis MJ. Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial. Am J Transplant. 2021 Jun;21(6):2175-2187. doi: 10.1111/ajt.16403. Epub 2021 Jan 4.
PubMed 33210831Strigo TS, Ephraim PL, Pounds I, Hill-Briggs F, Darrell L, Ellis M, Sudan D, Rabb H, Segev D, Wang NY, Kaiser M, Falkovic M, Lebov JF, Boulware LE. The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial. BMC Nephrol. 2015 Oct 9;16:160. doi: 10.1186/s12882-015-0153-y.
PubMed 26452366
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplant Social Worker Support for Live Kidney Donation in African Americans
- ClinicalTrials.gov ID
- NCT02369354
- Acronym / sponsor ID
- TALKS / Pro00052724
- Conditions
- Kidney Disease
- Keywords
- Kidney Transplant, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2015 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Posted 5 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual medical care at the Duke Kidney Transplant Clinic |
| TALKS | Other | Behavioral: TALKS Social Worker InterventionUsual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings |
| TALKS PLUS | Other | Behavioral: TALKS Social Worker Intervention, Other: Financial Assistance InterventionUsual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TALKS Social Worker InterventionTALKS 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. | Behavioural | TALKS, TALKS PLUS |
| Financial Assistance InterventionThe 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. | Other | TALKS PLUS |
Primary outcome
Number of Participants With Live Kidney Donor Activation Events
Time frame: 24 months post randomization
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.
3 secondary outcomes
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
Time frame: 24 months post randomization
Number of Participants With Live Donor Evaluations
Time frame: 24 months post randomization
Number of Participants With Live Kidney Donor Transplants
Time frame: 24 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33210831Boulware LE, Sudan DL, Strigo TS, Ephraim PL, Davenport CA, Pendergast JF, Pounds I, Riley JA, Falkovic M, Alkon A, Hill-Briggs F, Cabacungan AN, Barrett TM, Mohottige D, McElroy L, Diamantidis CJ, Ellis MJ. Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial. Am J Transplant. 2021 Jun;21(6):2175-2187. doi: 10.1111/ajt.16403. Epub 2021 Jan 4.
- Derived from this study: PubMed 26452366Strigo TS, Ephraim PL, Pounds I, Hill-Briggs F, Darrell L, Ellis M, Sudan D, Rabb H, Segev D, Wang NY, Kaiser M, Falkovic M, Lebov JF, Boulware LE. The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial. BMC Nephrol. 2015 Oct 9;16:160. doi: 10.1186/s12882-015-0153-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh E Boulware, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TALKS Social Worker Intervention and Financial Assistance Intervention in people with Kidney Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Live Kidney Donor Activation Events (time frame: 24 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369354, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.