Educational Intervention for Kidney Disease

(KidneyTIME Trial)

Overseen By Brad Bermudez

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Previous intervention exposure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

422 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Liise Kayler, MD

Principal Investigator

University at Buffalo

Eligibility Criteria

This trial is for adults over 18 who speak English, have internet access, and are referred to the transplant center for a kidney transplant. It's not open to those who've already seen parts of the intervention.

Inclusion Criteria

Speaks English

I am referred for a kidney transplant.

Has access to the internet

Exclusion Criteria

I have been treated with a component of the study intervention before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants receive the KidneyTIME intervention or usual care video, followed by surveys and ongoing video access

12 months

Monthly virtual prompts

Follow-up

Participants are monitored for living donor inquiries and other outcomes

12 months

Surveys at 1, 6, and 12 months

Exit Interview

Intervention participants are invited to an exit interview; controls offered access to intervention website

Treatment Details

Interventions

• Kidney donation and transplant information made easy

Trial Overview The study compares KidneyTIME—a video-based education and mobile communication tool about living-donor kidney transplants—with usual care. Participants are randomly placed into two groups to see if KidneyTIME improves knowledge and readiness over a year.

Participant Groups

Group I: KidneyTIME Experimental Treatment 1 Intervention

KidneyTIME is a self-directed digital intervention. It contains 26 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 26 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.

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+