Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication
Phase: NA
Conditions: End-stage Renal Disease, Chronic Kidney Diseases
Sponsor: State University of New York at Buffalo

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Randomized controlled trial of a digital intervention (KidneyTIME) to promote live 
donor kidney transplantation 
 
Liise K. Kayler MD MS1,2, Naoru Koizumi PhD 3, Jing Nie PhD4, Maria Keller PhD1,2,  
Heather Gardiner PhD1, MPH4, Jon Von Visger MD PhD2,5, Renee B. Cadzow PhD4,  
Katia Noyes PhD4, Thomas H. Feeley PhD6 
 
Affiliation 
1Department of Surgery, Jacobs School of Medicine and Biomedical Sciences at the 
University at Buffalo, Buffalo, NY 
2Transplant and Kidney Care Regional Center of Excellence, Erie County Medical Center, 
Buffalo, NY 
3Schar School of Policy and Government, George Mason University, Fairfax, VA 
4Department of Epidemiology, School of Public Health & Health Professions, University 
at Buffalo, State University of New York, Buffalo, NY 
5Division of Nephrology, Jacobs School of Medicine and Biomedical Sciences at the 
University at Buffalo, Buffalo, NY 
6Department of Communication, University at Buffalo, State University of New York, 
Buffalo, NY 
 
Clinical Trial Notation 
The trial was registered at ClinicalTrials.gov (#NCT05154773) 
 
Document Date 
1/9/2026 
 
Funding 
National Institute of Diabetes and Digestive and Kidney Diseases of the National 
Institutes of Health. Award number R01DK129845.  
 
 
 
 
 

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Trial Design 
This was a single-center, individually randomized, parallel group, posttest-only 
RCT (Figure 1). Using a digital automated system, two active interventions were 
delivered to kidney transplant candidates at Erie County Medical Center by email or text 
transmissions of web-based consent documents, surveys, and the interventions over 12 
months. Participants were randomly assigned in a race-stratified 1:1 allocation ratio to 
intervention (KidneyTIME) or active control arm. 
• Study arm 1 (KidneyTIME) remotely delivered prescribed online viewing of a 13-
minute LDKT-specific education video followed by email or text reminders to view 
and share optional web-based videos with more kidney transplant and living 
donation information (25 videos totaling 55 minutes). Fully described elsewhere1 the 
video curriculum includes the roles of patients, donors, and supporters. The 
webpage was smartphone-optimized and provided anyone with the opportunity to 
view and share videos.  
• Study arm 2 (active control) was a one-time online viewing of the center’s 13-minute 
usual care video, a nurse-narrated power-point-based video outlining recipient 
evaluation, surgery, recovery processes and outcomes while briefly highlighting the 
option of LDKT. It was utilized to offer participants education with perceived benefit 
and encourage further study participation. Both programs were considered active 
since they intended to aid kidney transplant access; however, the active control 
condition differed by quality/extent of content and lack of rewatching, electronic 
video sharing, and reminders. 
Recruitment  

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Recruitment and enrollment have been described in detail elsewhere.2 
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 to email or texting 
service.  
Enrollment 
Each KT-candidate was emailed or texted up to 3 time-based electronic 
invitations containing a unique link to an online consent form as well as verbal phone 
calls and in-clinic discussions by study staff until contact was made or enrollment 
ended. Participants were told they would receive transplant educational videos that 
could be shared with their social network; but were not told any specifics about the 
treatment arms or the studies’ aim to increase LDKT. Requests to use a carers’ 
email/text were accepted and recorded. The study team did not initiate further contact 
with any participant who declined to participate. Reasons for refusal were documented if 
provided. Clinical providers continued to deliver usual care to all participants and were 
not involved with delivery of the intervention. No information collected for study 
purposes was shared with the treating team. 
Randomization  
Those who signed electronic consent to participate were automatically guided to 
an online 24-item baseline survey assessing socio-demographics (age, sex, race, 

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education level, household income, co-habitation status, employment status), health 
(dialysis duration, prior transplant), technology access and use,3,4 health literacy,5 and 
social support.6 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. Assignment of each participant was concealed from 
transplant providers but unblinded to researchers. Participants did not know which 
intervention was the “intervention of interest” and which one was the comparator.  
Procedures 
     All participants received a 13-minute video embedded within the enrollment survey, 
either the KidneyTIME core video education or the transplant center’s usual care video, 
followed by an immediate posttest. The video could not be clicked through or 
rewatched. The KidneyTIME core video ended with a call to action to view more videos 
centralized on a publicly available website (currently transplantinfo.com). Starting the 
day after post-test completion and continuing every 3 weeks over a 12-month period, 
KidneyTIME participants were emailed or texted a unique link to the full video collection 
displayed on a study webpage, including messages describing the benefit of viewing 
and sharing the content. Through prominent share buttons, each video was activated for 
sharing using various modalities, including email, text, Facebook, and Twitter. Users 
(participants and their sharees) had continued access to the full video curriculum 
anywhere the internet is available and were allowed to interact freely on the sites based 
on their interests. Study staff did not contact participants to encourage individual use of 
the intervention. Participants were inactivated in the study if they died, received a 
transplant, or became ineligible according to the transplant center. All active study 

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participants were invited to fill out serial surveys immediately after core education and at 
1-, 6-, and 12-months post-access to the full digital intervention to examine difference in 
and maintenance of LDKT knowledge, concerns, and readiness, new behaviors, as well 
as video use and satisfaction with the intervention. Exit interviews were offered at the 
end of the 12-month survey; these results and responses to an open-ended survey 
question were reported previously.7 All participants received up to $125 for completing 
all study milestones (4 surveys and an exit interview). To reduce contamination, 
KidneyTIME was not actively promoted during the study period, except for electronic 
communications about the site to intervention arm participants. Participants in the 
control condition were offered a link to the KidneyTIME website upon study completion. 
Outcome Measures 
The primary outcome was at least one live kidney donor inquiry to the transplant 
center on behalf of the study participants within 12 months from enrollment. This is an 
upstream outcome pertinent to eventual LDKT. An ‘inquiry’ was defined as an 
expression of donation interest and must have occurred in person, by telephone, or by 
email and documented in the medical record. If yes, time (days) from intervention to first 
inquiry was captured for all patients as a discrete field in the dataset. Secondary patient 
reported outcomes, published in full detail elsewhere,2  were adapted from measures 
used in previous LDKT educational research including patients’ LDKT knowledge 
scores drawn from Kayler et al.8 (12 true-false questions; range 0-12), concerns scores 
adapted from Rodrigue et al.9 (6 items; 4-point Likert; range 4-24; Cronbach’s α=0.72), 
readiness score adapted from Rodrigue et al.9 (1 item; range 0-5), LDKT access 
behaviors adapted from Waterman et al.10 (5 items; range 0-5), extent of social outreach 

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via video sharing (3 groups: immediate family, extended family and friends, strangers), 
and program satisfaction (intervention arm only; 7 items; Cronbach’s α=0.98). 
Intervention individual-level video viewing data was recorded automatically by the 
intervention delivery system. We also measured prior exposure to the videos and device 
used.  
Sample Size 
Sample size was estimated on the basis of an 80-patient pilot study at our 
center.8 Anticipating a 30% base response rate, analyses targeting detection of a 
between-group difference of 15% in donor inquiry with 80% power and α=0.05 (2-
sided), required 163 per group with complete data or 408 total with adjustment for an 
anticipated 20% attrition rate. Despite achieving more than the expected sample size 
(n=422; overage due to a bolus of electronic enrollments in the final month); attrition 
was higher than anticipated and the intended final analytic sample size was not 
achieved resulting in reduced power to detect significant effects. Given this, the analysis 
now focuses on cumulative incidence of inquiry rather than proportional differences. 
Statistical Analyses  
Summary statistics were used to evaluate intervention usage and satisfaction 
scores. Group differences were compared using χ2-tests for binary categorical 
outcomes. Trial results were analyzed in all randomly assigned participants, 
representing the intention-to-treat population. We conducted Fine and Gray’s competing 
risk analysis to estimate sub-distribution hazard ratios (sHRs) for receiving at least one 
live donor inquiry, with transplantation and removal from evaluation as competing risks 
and censoring for end of follow-up.11,12 Poisson regression models tested the number of 

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new outreach behaviors. Poisson models were selected over binomial models based on 
the Akaike Information Criterion and Bayesian Information Criterion measures. Zero-
inflated versions of Poisson and binomial models were also explored without producing 
any improved goodness of fit, presumably due to limited (<5%) number of zeros at and 
after month 6. Generalized linear mixed models were used to relate the repeated 
measures’ continuous outcomes (knowledge, concerns, readiness). An unstructured 
covariance matrix was used and the outcome of interest was predicted by survey time 
point, condition status, and interaction between time point and condition. Effect size 
(Cohen’s d) was calculated for LDKT knowledge using immediate post-exposure data 
and reported as simple and standardized effect size.13 An additional ‘as-treated’ 
analysis, using competing risk analysis as described above, considered participants 
who were assigned to the intervention, but did not view at least one optional video, as 
controls. Covariates in all analyses included computer ownership, the only baseline 
variable not well balanced between conditions at p<0.05.  Analyses were conducted 
using SAS (SAS Institute, Inc, Ver. 9.4) or Stata (Stata Corp, Ver. 19). Statistical 
significance was set at p<0.05 without any adjustment given the single primary outcome 
and distinct secondary outcomes.14 
 
 
 
 
 
 

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