Hybrid Dissemination Study of A Digital-Analog Intervention to Increase Live Donor Kidney Transplantation

NCT07072767 | Not Yet Recruiting

• 1 other identifier: STUDY00014971
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a 2-arm randomized controlled trial among patients referred for kidney transplant evaluation at a single transplant center to compare the effects of a digital-analog intervention to increase living-donor kidney transplant access (KidneyTIME+) with or without human guide . Following consent and baseline assessment, participants are randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide.

Conditions

Chronic Kidney Diseases; Kidney Transplant; Living Kidney Donor; End-Stage Renal Disease

Keywords

pilot randomized trial; behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Living donor inquiry

  Count of living donor inquires to the transplant center on behalf of the study participants within 6 months from enrollment. Each inquiry (telephone call, email, letter) is counted and added to a discrete field for all patients in the electronic medical record.

  Baseline, post baseline 6 months

Secondary Outcomes (4)

• LDKT Perceived understanding

  Baseline, post baseline 6 months

• LDKT Conversational self-efficacy

  Baseline, post baseline 6 months

• LDKT Beliefs scale

  Baseline, post baseline 6 months

• Donor outreach behaviors

  Baseline, post baseline 6 months

Other Outcomes (3)

• Time to waiting-list placement

  12 months

• Intervention Acceptability

  Post-baseline 6 months

• Patient perception of donor offer

  Baseline, post baseline 6 months

Study Arms (2)

KidneyTime-2 with human support

EXPERIMENTAL

KidneyTIME-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Human guide support offered over a 6 month period to encourage use of the intervention and donor outreach.

Behavioral: Digital education outreach intervention for kidney transplant access and human guide

KidneyTime-2 without human support

ACTIVE COMPARATOR

KidneyTime-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Routine clinical support from non-study sources through usual Transplant Center protocols including clinic provider communications.

Behavioral: Digital education outreach intervention for kidney transplant access only (unguided)

Interventions

Digital education outreach intervention for kidney transplant access and human guide BEHAVIORAL

Receives (1) donor search materials, (2) electronic resource access messages, (3) practical assistance to use the intervention and empower taking the outreach action and (4) telephonic human guide

KidneyTime-2 with human support

Digital education outreach intervention for kidney transplant access only (unguided) BEHAVIORAL

Receives (1) donor search materials, (2) electronic resource access messages, and (3) practical assistance to use the intervention and empower taking the outreach action.

KidneyTime-2 without human support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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

You may not qualify if:

• Previously exposed to any component of the intervention
• Listed for a kidney transplant at another center (multilisted)
• Seeking multiorgan transplantation

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Erie County Medical Center, 462 Grider Street

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

Central Study Contacts

Liise Kayler, MD, MS, FACS

CONTACT

716-898-3318; lkayler@ecmc.edu

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: Principal Investigator

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: July 18, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)