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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK098759 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| TALKS PLUS | Other | Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TALKS Social Worker Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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For potential kidney transplant recipients (all arms):
Inclusion Criteria:
Exclusion Criteria:
For family members or friends of potential kidney transplant recipients (TALK and TALK PLUS arms):
Inclusion Criteria:
For potential live kidney donors (TALKS PLUS arm only)
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh E Boulware, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke School of Medicine, Division of General Internal Medicine | Durham | North Carolina | 27701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33210831 | Derived | 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. | |
| 26452366 |
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Family members or friends of potential kidney transplant recipients and potential live kidney donors were not enrolled in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual medical care at the Duke Kidney Transplant Clinic |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual medical care at the Duke Kidney Transplant Clinic |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 24 months post randomization |
|
24 months post randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual medical care at the Duke Kidney Transplant Clinic | 0 |
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The study was performed at a single transplant center, which may limit generalizability of results. The study's follow-up time may not have been sufficient for participants to identify new potential donors, initiate discussions, and for potential donors to become activated toward living kidney donation. Additionally, participants with longer wait-list times may have been less motivated to pursue LDKT. Lastly, we did not assess reasons for non-use of the TALKS financial assistance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. L. Ebony Boulware | Duke University School of Medicine | 919-613-2099 | ebony.boulware@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2022 | Jun 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2020 | Jun 14, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Financial Assistance Intervention | Other | 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. |
|
| 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. | 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. | 24 months post randomization |
| Strigo 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| Poverty | Count of Participants | Participants |
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| Medical Insurance | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Family members | Count of Participants | Participants |
|
| Total potential immediate family donors | Median | Inter-Quartile Range | potential immediate family donors |
|
| Family history of kidney disease | Count of Participants | Participants |
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| Health literacy | Count of Participants | Participants |
|
| Years on the waiting list | Median | Inter-Quartile Range | years |
|
| Current end-stage (ESRD) renal disease treatment | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | 24 months post randomization |
|
|
|
| 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. | Posted | Count of Participants | Participants | 24 months post randomization |
|
|
|
| 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. | Posted | Count of Participants | Participants | 24 months post randomization |
|
|
|
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | 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. | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | 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. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D052801 | Male Urogenital Diseases |
| No |
|
| No |
|
| No |
|
| High (Identified potential donor) |
|
| Data missing |
|
| Title | Measurements |
|---|---|
|
| 2 Evaluations |
|
| 3 Evaluations |
|
| 4 Evaluations |
|