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Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication

Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05154773
Acronym
KidneyTIME
Enrollment
422
Registered
2021-12-13
Start date
2022-04-01
Completion date
2026-04-20
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, End-stage Renal Disease

Keywords

Kidney transplant access, living kidney donation, education, web-based intervention, randomized controlled trial

Brief summary

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.

Detailed description

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).

Interventions

BEHAVIORALKidney donation and transplant information made easy

Same as arm description

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Intervention model description

Parallel randomized controlled trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* referred to the transplant center for a kidney transplant * aged 18 years and older * speaks English * has access to the internet

Exclusion criteria

* Previously exposed to any component of the intervention

Design outcomes

Primary

MeasureTime frameDescription
Living Donor Inquiry12 monthsLiving 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.

Secondary

MeasureTime frameDescription
Living Donor Kidney Transplant KnowledgeImmediately post baseline, 1 month, 6 month, and 12 monthsDeveloped 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.
Living Donor Kidney Transplant ConcernsImmediately post baseline, 1 month, 6 month, and 12 monthsDeveloped 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).
Living Donor Kidney Transplant ReadinessImmediately post baseline, 1 month, 6 month, and 12 monthsA 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).
Number of Participants With at Least One New Living Donor Kidney Transplant Access BehaviorImmediately post baseline, 1 month, 6 month, and 12 monthsA 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLiise Kayler, MD

University at Buffalo

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Baseline characteristics

Characteristic
Active Facebook account
Has active Facebook account
163 Participants
Active Facebook account
No active Facebook account
47 Participants
Age, Customized
Age 50-60 years
141 Participants
Age, Customized
Age < 50 years
64 Participants
Age, Customized
Age > 60 years
80 Participants
Basic Social Support
Basic Social Support (≥25th percentile)
159 Participants
Basic Social Support
Low Basic Social Support (<25th percentile)
51 Participants
Chronic dialysis treatment
No chronic dialysis treatment
49 Participants
Chronic dialysis treatment
Requires chronic dialysis treatment
155 Participants
Education
College degree
82 Participants
Education
No college degree
128 Participants
Employment status
Employed
42 Participants
Employment status
Not employed
159 Participants
Enrollment method
Enrolled using email
274 Participants
Enrollment method
Enrolled using text
72 Participants
EPTS at evaluation
EPTS at evaluation ≤ 70%
163 Participants
EPTS at evaluation
EPTS at evaluation > 70%
47 Participants
Evaluation phase at study entry
Post-evaluation phase at study entry
104 Participants
Evaluation phase at study entry
Pre-evaluation phase at study entry
108 Participants
Has working computer
Does not have working computer
7 Participants
Has working computer
Has working computer
203 Participants
Health Literacy
Health Literacy (≥25th percentile)
320 Participants
Health Literacy
Low Health Literacy (<25th percentile)
102 Participants
Household - adults
Living with other adult
308 Participants
Household - adults
Single adult household
114 Participants
Insurance type
Medicaid, state, or veterans insurance
109 Participants
Insurance type
No medicaid, state, or veterans insurance
209 Participants
Kidney transplants
No prior kidney transplant
180 Participants
Kidney transplants
Prior kidney transplant
51 Participants
Number of close friends or relatives
Number of close friends or relatives <4
206 Participants
Number of close friends or relatives
Number of close friends or relatives 4+
216 Participants
Race/Ethnicity, Customized
Black or African American, non-Hispanic
77 Participants
Race/Ethnicity, Customized
Hispanic or Latino
8 Participants
Race/Ethnicity, Customized
Other
18 Participants
Race/Ethnicity, Customized
White, non-Hispanic
113 Participants
Sex: Female, Male
Female
181 Participants
Sex: Female, Male
Male
241 Participants
Social media use
Does not use social media
51 Participants
Social media use
Uses social media
331 Participants
Total annual household income
Prefer not to answer
55 Participants
Total annual household income
Total annual household income ≤ $30,000
85 Participants
Total annual household income
Total annual household income $30,001-50,000
38 Participants
Total annual household income
Total annual household income > $50,000
55 Participants
Watches videos online
Does not watch videos online
50 Participants
Watches videos online
Watches videos online
184 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
8 / 2126 / 210
other
Total, other adverse events
0 / 2120 / 210
serious
Total, serious adverse events
0 / 2120 / 210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026