NCT01855438

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

2.9 years

First QC Date

May 13, 2013

Last Update Submit

February 19, 2018

Conditions

Kidney Transplant Candidates

Keywords

Live donor kidney transplantationLiving donationPatient educationKidney transplant candidates

Outcome Measures

Primary Outcomes (1)

  • Change in the number of individuals screened as potential living donors

    1 self-reported item

    Upon enrollment (baseline); 1 month post; 3 months post

Secondary Outcomes (3)

  • Change in intentions to discuss live donor kidney transplantation

    Upon enrollment (baseline); 1 month post; 3 months post

  • Change in engagement in discussion about live donor kidney transplantation

    Upon enrollment (baseline); 1 month post; 3 months post

  • Change in the number of living donor kidney transplants performed

    At study commencement; after all program sessions (interventions) are completed; at study conclusion

Study Arms (3)

Usual Care

NO INTERVENTION

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.

Living Donor Transplant Education 1

EXPERIMENTAL

Participants randomized to Living Donor Transplant Education 1 will receive education on living donor kidney transplantation and its discussion.

Behavioral: Living Donor Transplant Education

Living Donor Transplant Education 2

EXPERIMENTAL

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

Interventions

Living Donor Transplant EducationBEHAVIORAL

The Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic.

Living Donor Transplant Education 1Living Donor Transplant Education 2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Heather M Traino, PhD, MPH

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 16, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations

US(1)