Living Donation and Kidney Transplantation Information (KIDNEYTIME)

February 25, 2020 updated by: Liise Kayler, State University of New York at Buffalo

Living Donation and Kidney Transplantation Information Made Easy (KIDNEYTIME) With Animated Video Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective randomized parallel controlled trial of kidney transplant candidates receiving and educational intervention and standard of care education versus standard of care education only to improve informed decision making about kidney offers.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Video
Participants were exposed to 2 educational videos in addition to standard of care education.
Other: Educational Video Intervention
Educational videos
No Intervention: Standard of Care
Participants received standard of care education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knowledge
Time Frame: Baseline and immediately post exposure
Assessed by knowledge survey pre and post exposure.
Baseline and immediately post exposure
Change in attitude about kidney offers
Time Frame: Baseline and immediately post exposure
Assessed by attitude survey pre and post exposure.
Baseline and immediately post exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subjective decisional self-efficacy
Time Frame: Baseline and immediately post exposure
Assessed by self-efficacy survey pre and post exposure.
Baseline and immediately post exposure
Participation and decision making
Time Frame: 1 day (During standard of care education at time of clinic visit)
Number of questions and value statements in regards to organ offers.
1 day (During standard of care education at time of clinic visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Liise Kayler, MD, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Actual)

August 29, 2019

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00002771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplantation

Clinical Trials on Educational Video Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe