Increasing Communication About Live Donor Kidney Transplant

February 19, 2018 updated by: Virginia Commonwealth University

Increasing Communication About Live Donor Kidney Transplant: A Proof of Concept

This study will test the efficacy of a communication intervention intended to increase and improve kidney transplant candidates' communication about live donor kidney transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

236

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
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

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:

  • Wait listed for kidney transplantation in active status (i.e., status 1 or 2)
  • Adult (at least 18 years of age)
  • English speaking
  • Capable of making medical decisions (i.e., not cognitively impaired)
  • Non-institutionalized

Exclusion Criteria:

  • Not listed for kidney transplantation or wait listed, but not in active status
  • Under 18 years of age
  • Non-English speaking
  • Cognitively impaired
  • Institutionalized

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Kidney transplant candidates randomized to this arm will receive only the education provided by the transplant center. After data collection activities have concluded, transplant candidates in this arm will be offered the opportunity to attend a program session.
Experimental: Living Donor Transplant Education 1
Participants randomized to Living Donor Transplant Education 1 will receive education on living donor kidney transplantation and its discussion.
Behavioral: Living Donor Transplant Education
The Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic.
Experimental: Living Donor Transplant Education 2
Participants randomized to Living Donor Transplant Education 2 will receive education on living donor kidney transplantation and its discussion; they will also have the opportunity to practice discussing living kidney transplantation with simulated patients portraying participants' conversational partners.
Behavioral: Living Donor Transplant Education
The Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the number of individuals screened as potential living donors
Time Frame: Upon enrollment (baseline); 1 month post; 3 months post
1 self-reported item
Upon enrollment (baseline); 1 month post; 3 months post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intentions to discuss live donor kidney transplantation
Time Frame: Upon enrollment (baseline); 1 month post; 3 months post
3-item, 7-point Likert-type scale
Upon enrollment (baseline); 1 month post; 3 months post
Change in engagement in discussion about live donor kidney transplantation
Time Frame: Upon enrollment (baseline); 1 month post; 3 months post
2 self-reported items: whether live donor kidney transplantation was discussed (yes/no) and number of discussions held
Upon enrollment (baseline); 1 month post; 3 months post
Change in the number of living donor kidney transplants performed
Time Frame: At study commencement; after all program sessions (interventions) are completed; at study conclusion
At study commencement; after all program sessions (interventions) are completed; at study conclusion

Collaborators and Investigators

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

Sponsor

Virginia Commonwealth University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Heather M Traino, PhD, MPH, Virginia Commonwealth University

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

May 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM12097
  • PD302305 (Other Identifier: VCU)

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.

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