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

NCT05154773 | Active Not Recruiting

• 1 other identifier: STUDY00005449
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease; Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 recipient is specified.

  12 months

Secondary Outcomes (4)

• LDKT Knowledge scale

  immediately post baseline, 1 month, 6 month, and 12 months

• LDKT Concerns Scale

  immediately post baseline, 1 month, 6 month, and 12 months

• LDKT Readiness

  immediately post baseline, 1 month, 6 month, and 12 months

• LDKT action behaviors

  immediately post baseline, 1 month, 6 month, and 12 months

Other Outcomes (1)

• Time to waiting-list placement

  12 months

Study Arms (2)

KidneyTIME

EXPERIMENTAL

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.

Behavioral: Kidney donation and transplant information made easy

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.

Interventions

Kidney donation and transplant information made easy BEHAVIORAL

Same as arm description

Also known as: KidneyTIME

KidneyTIME

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previously exposed to any component of the intervention

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liise Kayler, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 13, 2021
• Study Start: April 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: March 30, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 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.
• Access Criteria: 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

Locations

US (1)