Increasing Communication About Live Donor Kidney Transplant

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01855438
First received: May 13, 2013
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Kidney Transplant Candidates
Behavioral: Living Donor Transplant Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Increasing Communication About Live Donor Kidney Transplant: A Proof of Concept

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in the number of individuals screened as potential living donors [ Time Frame: Upon enrollment (baseline); 1 month post; 3 months post ] [ Designated as safety issue: No ]
    1 self-reported item


Secondary Outcome Measures:
  • Change in intentions to discuss live donor kidney transplantation [ Time Frame: Upon enrollment (baseline); 1 month post; 3 months post ] [ Designated as safety issue: No ]
    3-item, 7-point Likert-type scale

  • Change in engagement in discussion about live donor kidney transplantation [ Time Frame: Upon enrollment (baseline); 1 month post; 3 months post ] [ Designated as safety issue: No ]
    2 self-reported items: whether live donor kidney transplantation was discussed (yes/no) and number of discussions held

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: June 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855438

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Heather M Traino, PhD, MPH Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01855438     History of Changes
Other Study ID Numbers: PD302305
Study First Received: May 13, 2013
Last Updated: August 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Live donor kidney transplantation
Living donation
Patient education
Kidney transplant candidates

ClinicalTrials.gov processed this record on August 25, 2014