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The study is a- 2-arm randomized controlled trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of a patient-based self-learning and outreach intervention about living-donor kidney transplantation (KidneyTIME) versus usual care for living-donor kidney transplant knowledge, concerns, readiness, access behaviors, and living-donor inquiries over 12 months follow-up. Following consent and baseline assessment, participants were randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care.
Over a 2.5 year period we will conduct a 2-arm parallel randomized trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of KidneyTIME versus usual care for KTX access over 12 months of intervention use and follow-up.
Participants will be recruited from the Transplant program at Erie County Medical Center, a safety-net hospital in Buffalo, New York. Each week, electronic records will be accessed to identify potential participants who had been referred to the transplant center for a kidney transplant, are aged 18 years and older, speak English, have internet access, and signed electronic consent as well as provided a text or email address. We will excude patients previously exposed to any component of the intervention.
Each potential participant will be sent an electronic invitation from the principal investigator (a transplant surgeon). This message will briefly described the study and include a personal link to an online consent form describing study procedures and potential risks. A stakeholder Advisory Council, whose members include patients and care partners, will review and provide ongoing feedback on the recruitment and retention plan.
The entire study and the progress tracker will be hosted on Alchemer. Those who sign electronic consent to participate will be automatically guided to a baseline sociodemographic survey (T0). Upon completion, computer-generated randomization will stratify participants by self-reported race (Black versus Other), with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care. Condition assignment of each participant will be concealed from transplant providers, but participants will become aware of their treatment assignment one they access the study educational content.
KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. All components of the intervention were developed through a user-centered design approach by involving kidney failure patients and social network members, to improve usability and increase the likelihood of adoption.
In the intervention arm, we chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. The first video sets the stage for the intervention and introduces the viewer to an overview of LDKT. The next 5 videos address common misconceptions about live kidney donation: Video 1: LDKT introduction, Video 2: Donor eligibility, Video 3: Donor evaluation, Video 4: Kidney paired donation, Video 5: Donation Costs, Video 6: Donor lifestyle. After completing the proscribed videos and an immediate-post exposure survey, everyone then receives a link to access all 25 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website can be accessed using this link from any electronic device throughout the study. Website use will be prompted by automated messages (email or SMS) that introduced videos that may interest users, provided the website link, and encouraged video viewing and sharing. Messages will be personalized with their name and provide researchers contact information. Prompts will be sent monthly for 12 months.
Control participants will receive the transplant program's 13-minute usual care video, a nurse-narrated power-point-based video outlining recipient evaluation, surgery, recovery processes and outcomes while highlighting the option of LDKT. This condition was active since it intended to aid kidney transplant access. It was utilized to offer participants education with perceived benefit and encourage further study participation.
All participants routinely receive educational materials from non-study sources through usual Transplant Center protocols including written materials, nurse communications, and the usual care video shown on a clinic computer during transplant evaluation. Therefore control participants viewed the usual care video twice.
After completing the proscribed video education, all participants will be invited to fill out serial surveys immediately (T1) and 1 month (T2), 6 months (T3), and 12-months (T4) post-baseline. Participants will receive up to 6 reminders (5 automatic and 1 personalized) to complete surveys. At study conclusion, intervention participants will be invited to an exit interview and controls will be offered access to the intervention website. All participants will receive up to $125 for completing study milestones (4 surveys and an exit interview).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KidneyTIME | Experimental | KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. We chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. After completing the proscribed videos and an immediate-post exposure survey, everyone then received a link to access all 25 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website could be accessed using this link from any electronic device throughout the study. Prompts to use the intervention were sent once a week for 3 weeks and then monthly for 12 months. |
|
| Usual Care | No Intervention | Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney donation and transplant information made easy | Behavioral | Same as arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Living Donor Inquiry | Living donor inquiry to the transplant center on behalf of the participant by telephone, email, or mail within 12 months from enrollment. Each inquiry is captured for all patients as a discrete field in the electronic medical record within 12 months from enrollment. An inquiry includes any request for information or evaluation to be a living kidney donor in which the recipients' name is specified. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Living Donor Kidney Transplant Knowledge | Developed specifically for this study as a measure of patients' knowledge about LDKT as delivered in the intervention condition. In this 12-item true-false questionnaire, total scores range from 0-12 with higher scores indicating greater LDKT-related knowledge. The scale captured different dimensions of knowledge including donor eligibility criteria, clinical outcomes, costs of the donation procedure, donor diet and medications, donor priority for transplant, and kidney paired donation. |
| Measure | Description | Time Frame |
|---|---|---|
| Active Placement on Kidney Transplant Waiting List | Number of Participants with Active Placement on Kidney Transplant Waiting List | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liise Kayler, MD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
We will make all data available upon request.
The deidentified participant data and data dictionary data set will be made available upon request. The dataset will be archived for at least 10 years after publication.
Researcher meets University at Buffalo IRB guidelines for data sharing. Request to the PI team at our institution for any valid scientific purpose and after publication
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Upon completion, simple computer-generated randomization stratified participants, by self-reported race (Black or African-American vs other), with equal allocation to 2 treatment arms.
Participants were recruited between April 2022 and July 2023 from the transplant program, located in a safety-net hospital in Buffalo, New York. Each week, electronic records identified English-speaking adults (18 years and older) referred to the center for kidney transplantation, including those with a scheduled appointment to be evaluated, undergoing evaluation, or already waitlisted for a transplant. Patients were excluded for prior exposure to any LDKT access intervention and lack of access.
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| ID | Title | Description |
|---|---|---|
| FG000 | KidneyTIME | KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. We chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. After completing the proscribed videos and an immediate-post exposure survey, everyone then received a link to access all 25 videos centralized on a landing page and a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The landing page could be accessed using a personalized link and the website could be accessed using a URL from any electronic device throughout the study. Email or text prompts to use the intervention were sent once a week for 3 weeks and then monthly for 12 months. Kidney donation and transplant information made easy: Same as arm description |
| FG001 | Usual Care | Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | KidneyTIME | KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. We chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. After completing the proscribed videos and an immediate-post exposure survey, everyone then received a link to access all 25 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website could be accessed using this link from any electronic device throughout the study. Prompts to use the intervention were sent once a week for 3 weeks and then monthly for 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age less than 50, between 50 and 60, over 60 |
| 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 | Living Donor Inquiry | Living donor inquiry to the transplant center on behalf of the participant by telephone, email, or mail within 12 months from enrollment. Each inquiry is captured for all patients as a discrete field in the electronic medical record within 12 months from enrollment. An inquiry includes any request for information or evaluation to be a living kidney donor in which the recipients' name is specified. | English-speaking adults (18 years and older) referred to the center for kidney transplantation, including those with a scheduled appointment to be evaluated, undergoing evaluation, or already waitlisted for a transplant. Patients were excluded for prior exposure to any LDKT access intervention and lack of access to email or texting service. | Posted | Number | Percentage of participants | 12 months |
|
From enrollment up to 1 year
During all phases of the research, transplant medical personnel were available. In addition, professional counseling was available. None of the participants contacted us to report any adverse emotional reactions to video materials. None of the participants reported to the research team during the exposure any feelings of discomfort or feeling overly strained.
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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 | KidneyTIME | KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. We chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. After completing the proscribed videos and an immediate-post exposure survey, everyone then received a link to access all 25 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website could be accessed using this link from any electronic device throughout the study. Prompts to use the intervention were sent once a week for 3 weeks and then monthly for 12 months. |
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The intended sample size was met; however, high attrition rates at each phase of service provision (from attending the evaluation to transplant) might have confounded the analysis and resulted in an inadequate final analytic sample, limiting power to detect differences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deirdre O'Rourke | University at Buffalo | 716-645-4421 | do8@bufalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2026 | Jan 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Parallel randomized controlled trial
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| Immediately post baseline, 1 month, 6 month, and 12 months |
| Living Donor Kidney Transplant Concerns | Developed specifically for this study as a measure of patients' concerns about LDKT. Questions were drawn from existing measures in the literature. We created a 6-item scale that captured concerns about LDKT including donation costs, evaluation process, function with a single kidney, poor outcome, and surgical risk as well as one question about access to deceased-donor kidney transplantation. Items are rated on a scale of 1 to 4, with the total score range 6 - 24. Higher scores indicate greater concerns about live kidney donation (a worse outcome). | Immediately post baseline, 1 month, 6 month, and 12 months |
| Living Donor Kidney Transplant Readiness | A measure of one's readiness for living-donor kidney transplantation. This 1-item scale measures the degree to which a person is ready for LDKT and is adapted from existing measures in the literature. Response options correspond to 5 stages of change based on the Transtheoretical Model and Stages of Change and are rated on a scale of 1 to 5 (minimum total value 1 and maximum total value 5) with higher scores indicating greater readiness (a better outcome). | Immediately post baseline, 1 month, 6 month, and 12 months |
| Number of Participants With at Least One New Living Donor Kidney Transplant Access Behavior | A measure to assess LDKT access behaviors. Patients were asked if they had done any of 5 transplant-related behaviors adapted from existing measures in the literature at baseline and at 1, 6, and 12 months. Statistical comparisons are based on Fisher's exact test. Proportions indicate at least one new behavior enacted after baseline. | Immediately post baseline, 1 month, 6 month, and 12 months |
| BG001 | Usual Care | Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Biological sex - Female or Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Evaluation phase at study entry | Count of Participants | Participants |
|
| Enrollment method | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Household - adults | Count of Participants | Participants |
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| Kidney transplants | Count of Participants | Participants |
|
| Chronic dialysis treatment | Count of Participants | Participants |
|
| EPTS at evaluation | Estimated Post-transplant Survival. Based on a range of 0%-100%, higher scores predict worse patient survival. | Count of Participants | Participants |
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| Insurance type | Count of Participants | Participants |
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| Employment status | Count of Participants | Participants |
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| Total annual household income | The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values. | Count of Participants | Participants |
|
| Number of close friends or relatives | Count of Participants | Participants |
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| Has working computer | Count of Participants | Participants |
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| Watches videos online | Count of Participants | Participants |
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| Social media use | Count of Participants | Participants |
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| Active Facebook account | Count of Participants | Participants |
|
| Health Literacy | Health literacy was measured with two items scored on 4-point Likert-type scales: "How often do you have someone help you read hospital materials?" "How confident are you filling out forms by yourself?" The two items were combined to score health literacy as one measure. | Count of Participants | Participants |
|
| Basic Social Support | Basic Social Support was measured by a 6-item survey with items scored on 4-point Likert-type scales (4 options): Frequency someone is available to: prepare meals if unable to do so [instrumental], take to doctor if needed [instrumental], help with daily shores if sick [instrumental], give good advice about crisis [emotional], confide or talk to about problems [emotional], who can understand your problems [emotional]. The six items were combined to score basic social support as one measure. | Count of Participants | Participants |
|
| OG001 | Usual Care | Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes. |
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| Secondary | Living Donor Kidney Transplant Knowledge | Developed specifically for this study as a measure of patients' knowledge about LDKT as delivered in the intervention condition. In this 12-item true-false questionnaire, total scores range from 0-12 with higher scores indicating greater LDKT-related knowledge. The scale captured different dimensions of knowledge including donor eligibility criteria, clinical outcomes, costs of the donation procedure, donor diet and medications, donor priority for transplant, and kidney paired donation. | 93% (392/422) completed the intervention core education and immediate-post survey. The lower completion at M1, M6, and M12 is due to survey non-response, transplant ineligibility, or already transplanted. | Posted | Jan 2026 | Mean | Standard Deviation | Scores on a scale | Immediately post baseline, 1 month, 6 month, and 12 months |
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| Secondary | Living Donor Kidney Transplant Concerns | Developed specifically for this study as a measure of patients' concerns about LDKT. Questions were drawn from existing measures in the literature. We created a 6-item scale that captured concerns about LDKT including donation costs, evaluation process, function with a single kidney, poor outcome, and surgical risk as well as one question about access to deceased-donor kidney transplantation. Items are rated on a scale of 1 to 4, with the total score range 6 - 24. Higher scores indicate greater concerns about live kidney donation (a worse outcome). | 93% (392/422) completed the intervention core education and immediate-post survey. The lower completion at M1, M6, and M12 is due to survey non-response, transplant ineligibility, or already transplanted. | Posted | Mean | Standard Deviation | Scores on a scale | Immediately post baseline, 1 month, 6 month, and 12 months |
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| Secondary | Living Donor Kidney Transplant Readiness | A measure of one's readiness for living-donor kidney transplantation. This 1-item scale measures the degree to which a person is ready for LDKT and is adapted from existing measures in the literature. Response options correspond to 5 stages of change based on the Transtheoretical Model and Stages of Change and are rated on a scale of 1 to 5 (minimum total value 1 and maximum total value 5) with higher scores indicating greater readiness (a better outcome). | 93% (392/422) completed the intervention core education and immediate-post survey. The lower completion at M1, M6, and M12 is due to survey non-response, transplant ineligibility, or already transplanted. | Posted | Mean | Standard Deviation | Scores on a scale | Immediately post baseline, 1 month, 6 month, and 12 months |
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| Secondary | Number of Participants With at Least One New Living Donor Kidney Transplant Access Behavior | A measure to assess LDKT access behaviors. Patients were asked if they had done any of 5 transplant-related behaviors adapted from existing measures in the literature at baseline and at 1, 6, and 12 months. Statistical comparisons are based on Fisher's exact test. Proportions indicate at least one new behavior enacted after baseline. | The overall number of participants analyzed completed immediate post and at least one additional survey at month 1, 6 or 12. | Posted | Count of Participants | Participants | Immediately post baseline, 1 month, 6 month, and 12 months |
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| Other Pre-specified | Active Placement on Kidney Transplant Waiting List | Number of Participants with Active Placement on Kidney Transplant Waiting List | Posted | Count of Participants | Participants | 12 months |
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| 8 |
| 212 |
| 0 |
| 212 |
| 0 |
| 212 |
| EG001 | Usual Care | Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes. | 6 | 210 | 0 | 210 | 0 | 210 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 Months |
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| 12 Months |
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| 1 Month |
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| 6 Months |
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