Trial Outcomes & Findings for Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication (NCT NCT05154773)

NCT ID: NCT05154773

Last Updated: 2026-05-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

422 participants

Primary outcome timeframe

12 months

Results posted on

2026-05-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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
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.
Overall Study
STARTED
212
210
Overall Study
COMPLETED
199
193
Overall Study
NOT COMPLETED
13
17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Usual Care
n=210 Participants
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.
Total
n=422 Participants
Total of all reporting groups
KidneyTIME
n=212 Participants
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.
Age, Customized
Age < 50 years
64 Participants
n=210 Participants
129 Participants
n=422 Participants
65 Participants
n=212 Participants
Age, Customized
Age 50-60 years
66 Participants
n=210 Participants
141 Participants
n=422 Participants
75 Participants
n=212 Participants
Age, Customized
Age > 60 years
80 Participants
n=210 Participants
152 Participants
n=422 Participants
72 Participants
n=212 Participants
Sex: Female, Male
Female
87 Participants
n=210 Participants
181 Participants
n=422 Participants
94 Participants
n=212 Participants
Sex: Female, Male
Male
123 Participants
n=210 Participants
241 Participants
n=422 Participants
118 Participants
n=212 Participants
Race/Ethnicity, Customized
Black or African American, non-Hispanic
77 Participants
n=210 Participants
151 Participants
n=422 Participants
74 Participants
n=212 Participants
Race/Ethnicity, Customized
White, non-Hispanic
113 Participants
n=210 Participants
220 Participants
n=422 Participants
107 Participants
n=212 Participants
Race/Ethnicity, Customized
Hispanic or Latino
8 Participants
n=210 Participants
21 Participants
n=422 Participants
13 Participants
n=212 Participants
Race/Ethnicity, Customized
Other
12 Participants
n=210 Participants
30 Participants
n=422 Participants
18 Participants
n=212 Participants
Evaluation phase at study entry
Pre-evaluation phase at study entry
106 Participants
n=210 Participants
214 Participants
n=422 Participants
108 Participants
n=212 Participants
Evaluation phase at study entry
Post-evaluation phase at study entry
104 Participants
n=210 Participants
208 Participants
n=422 Participants
104 Participants
n=212 Participants
Enrollment method
Enrolled using email
138 Participants
n=210 Participants
274 Participants
n=422 Participants
136 Participants
n=212 Participants
Enrollment method
Enrolled using text
72 Participants
n=210 Participants
148 Participants
n=422 Participants
76 Participants
n=212 Participants
Education
No college degree
128 Participants
n=210 Participants
256 Participants
n=422 Participants
128 Participants
n=212 Participants
Education
College degree
82 Participants
n=210 Participants
166 Participants
n=422 Participants
84 Participants
n=212 Participants
Household - adults
Single adult household
54 Participants
n=210 Participants
114 Participants
n=422 Participants
60 Participants
n=212 Participants
Household - adults
Living with other adult
156 Participants
n=210 Participants
308 Participants
n=422 Participants
152 Participants
n=212 Participants
Kidney transplants
Prior kidney transplant
19 Participants
n=210 Participants
51 Participants
n=422 Participants
32 Participants
n=212 Participants
Kidney transplants
No prior kidney transplant
191 Participants
n=210 Participants
371 Participants
n=422 Participants
180 Participants
n=212 Participants
Chronic dialysis treatment
Requires chronic dialysis treatment
155 Participants
n=210 Participants
318 Participants
n=422 Participants
163 Participants
n=212 Participants
Chronic dialysis treatment
No chronic dialysis treatment
55 Participants
n=210 Participants
104 Participants
n=422 Participants
49 Participants
n=212 Participants
EPTS at evaluation
EPTS at evaluation > 70%
47 Participants
n=210 Participants
93 Participants
n=422 Participants
46 Participants
n=212 Participants
EPTS at evaluation
EPTS at evaluation ≤ 70%
163 Participants
n=210 Participants
329 Participants
n=422 Participants
166 Participants
n=212 Participants
Insurance type
Medicaid, state, or veterans insurance
104 Participants
n=210 Participants
213 Participants
n=422 Participants
109 Participants
n=212 Participants
Insurance type
No medicaid, state, or veterans insurance
106 Participants
n=210 Participants
209 Participants
n=422 Participants
103 Participants
n=212 Participants
Employment status
Employed
51 Participants
n=210 Participants
93 Participants
n=422 Participants
42 Participants
n=212 Participants
Employment status
Not employed
159 Participants
n=210 Participants
329 Participants
n=422 Participants
170 Participants
n=212 Participants
Total annual household income
Total annual household income ≤ $30,000
85 Participants
n=210 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
187 Participants
n=419 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
102 Participants
n=209 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
Total annual household income
Total annual household income $30,001-50,000
38 Participants
n=210 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
76 Participants
n=419 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
38 Participants
n=209 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
Total annual household income
Total annual household income > $50,000
55 Participants
n=210 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
101 Participants
n=419 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
46 Participants
n=209 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
Total annual household income
Prefer not to answer
32 Participants
n=210 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
55 Participants
n=419 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
23 Participants
n=209 Participants • The difference in KidneyTIME condition and overall numbers (209 vs 212) is due to missing values.
Number of close friends or relatives
Number of close friends or relatives 4+
117 Participants
n=210 Participants
216 Participants
n=422 Participants
99 Participants
n=212 Participants
Number of close friends or relatives
Number of close friends or relatives <4
93 Participants
n=210 Participants
206 Participants
n=422 Participants
113 Participants
n=212 Participants
Has working computer
Has working computer
203 Participants
n=210 Participants
335 Participants
n=422 Participants
132 Participants
n=212 Participants
Has working computer
Does not have working computer
7 Participants
n=210 Participants
87 Participants
n=422 Participants
80 Participants
n=212 Participants
Watches videos online
Watches videos online
188 Participants
n=210 Participants
372 Participants
n=422 Participants
184 Participants
n=212 Participants
Watches videos online
Does not watch videos online
22 Participants
n=210 Participants
50 Participants
n=422 Participants
28 Participants
n=212 Participants
Social media use
Uses social media
170 Participants
n=210 Participants
331 Participants
n=422 Participants
161 Participants
n=212 Participants
Social media use
Does not use social media
40 Participants
n=210 Participants
91 Participants
n=422 Participants
51 Participants
n=212 Participants
Active Facebook account
Has active Facebook account
163 Participants
n=210 Participants
321 Participants
n=422 Participants
158 Participants
n=212 Participants
Active Facebook account
No active Facebook account
47 Participants
n=210 Participants
101 Participants
n=422 Participants
54 Participants
n=212 Participants
Health Literacy
Low Health Literacy (<25th percentile)
54 Participants
n=210 Participants
102 Participants
n=422 Participants
48 Participants
n=212 Participants
Health Literacy
Health Literacy (≥25th percentile)
156 Participants
n=210 Participants
320 Participants
n=422 Participants
164 Participants
n=212 Participants
Basic Social Support
Low Basic Social Support (<25th percentile)
51 Participants
n=210 Participants
107 Participants
n=422 Participants
56 Participants
n=212 Participants
Basic Social Support
Basic Social Support (≥25th percentile)
159 Participants
n=210 Participants
315 Participants
n=422 Participants
156 Participants
n=212 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Usual Care
n=193 Participants
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.
KidneyTIME
n=199 Participants
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. 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
Living Donor Inquiry
18.6 Percentage of participants
16.0 Percentage of participants

SECONDARY outcome

Timeframe: Immediately post baseline, 1 month, 6 month, and 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Usual Care
n=193 Participants
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.
KidneyTIME
n=199 Participants
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. 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
Living Donor Kidney Transplant Knowledge
Immediate
10.4 Scores on a scale
Standard Deviation 1.4
11.1 Scores on a scale
Standard Deviation 1.2
Living Donor Kidney Transplant Knowledge
1 Month
10.4 Scores on a scale
Standard Deviation 1.8
11.1 Scores on a scale
Standard Deviation 1.3
Living Donor Kidney Transplant Knowledge
6 Months
10.6 Scores on a scale
Standard Deviation 1.4
11.0 Scores on a scale
Standard Deviation 1.3
Living Donor Kidney Transplant Knowledge
12 Months
10.3 Scores on a scale
Standard Deviation 2.1
11.1 Scores on a scale
Standard Deviation 1.6

SECONDARY outcome

Timeframe: Immediately post baseline, 1 month, 6 month, and 12 months

Population: 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.

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).

Outcome measures

Outcome measures
Measure
Usual Care
n=193 Participants
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.
KidneyTIME
n=199 Participants
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. 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
Living Donor Kidney Transplant Concerns
Immediate
11.2 Scores on a scale
Standard Deviation 3.0
10.7 Scores on a scale
Standard Deviation 3.0
Living Donor Kidney Transplant Concerns
1 Month
11.6 Scores on a scale
Standard Deviation 3.1
11.1 Scores on a scale
Standard Deviation 1.2
Living Donor Kidney Transplant Concerns
6 Months
11.9 Scores on a scale
Standard Deviation 2.8
11.2 Scores on a scale
Standard Deviation 2.9
Living Donor Kidney Transplant Concerns
12 Months
11.7 Scores on a scale
Standard Deviation 2.8
10.9 Scores on a scale
Standard Deviation 3.3

SECONDARY outcome

Timeframe: Immediately post baseline, 1 month, 6 month, and 12 months

Population: 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.

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).

Outcome measures

Outcome measures
Measure
Usual Care
n=193 Participants
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.
KidneyTIME
n=199 Participants
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. 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
Living Donor Kidney Transplant Readiness
Immediate
2.5 Scores on a scale
Standard Deviation 1.2
2.7 Scores on a scale
Standard Deviation 1.1
Living Donor Kidney Transplant Readiness
1 Month
1.7 Scores on a scale
Standard Deviation 1.1
2.8 Scores on a scale
Standard Deviation 1.0
Living Donor Kidney Transplant Readiness
6 Months
2.6 Scores on a scale
Standard Deviation 1.1
2.8 Scores on a scale
Standard Deviation 1.1
Living Donor Kidney Transplant Readiness
12 Months
2.7 Scores on a scale
Standard Deviation 1.3
2.8 Scores on a scale
Standard Deviation 1.3

SECONDARY outcome

Timeframe: Immediately post baseline, 1 month, 6 month, and 12 months

Population: The overall number of participants analyzed completed immediate post and at least one additional survey at month 1, 6 or 12.

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.

Outcome measures

Outcome measures
Measure
Usual Care
n=122 Participants
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.
KidneyTIME
n=118 Participants
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. 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
Number of Participants With at Least One New Living Donor Kidney Transplant Access Behavior
54 Participants
78 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Number of Participants with Active Placement on Kidney Transplant Waiting List

Outcome measures

Outcome measures
Measure
Usual Care
n=210 Participants
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.
KidneyTIME
n=212 Participants
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. 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
Active Placement on Kidney Transplant Waiting List
113 Participants
105 Participants

Adverse Events

KidneyTIME

Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deirdre O'Rourke

University at Buffalo

Phone: 716-645-4421

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place