NCT04285203

Brief Summary

The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

February 10, 2020

Last Update Submit

February 25, 2020

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

  • Change in knowledge

    Assessed by knowledge survey pre and post exposure.

    Baseline and immediately post exposure

  • Change in attitude about kidney offers

    Assessed by attitude survey pre and post exposure.

    Baseline and immediately post exposure

Secondary Outcomes (2)

  • Change in subjective decisional self-efficacy

    Baseline and immediately post exposure

  • Participation and decision making

    1 day (During standard of care education at time of clinic visit)

Study Arms (2)

Educational Video

EXPERIMENTAL

Participants were exposed to 2 educational videos in addition to standard of care education.

Other: Educational Video Intervention

Standard of Care

NO INTERVENTION

Participants received standard of care education.

Interventions

Educational Video InterventionOTHER

Educational videos

Educational Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be 18 years or older,
  • understand and read English (or have a support person that helps them)
  • have acceptable vision to watch videos
  • be able to give consent

You may not qualify if:

  • incarcerated
  • involved in the former modeling phase of animation development.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Study Officials

  • Liise Kayler, MD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 26, 2020

Study Start

April 8, 2019

Primary Completion

August 29, 2019

Study Completion

February 10, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)