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Increasing Communication About Live Donor Kidney Transplant

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ClinicalTrials.gov Identifier: NCT01855438
Recruitment Status : Active, not recruiting
First Posted : May 16, 2013
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Kidney Transplant Candidates Behavioral: Living Donor Transplant Education

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Increasing Communication About Live Donor Kidney Transplant: A Proof of Concept
Study Start Date : May 2013
Primary Completion Date : April 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855438


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Heather M Traino, PhD, MPH Virginia Commonwealth University
More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01855438     History of Changes
Other Study ID Numbers: HM12097
PD302305 ( Other Identifier: VCU )
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

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