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Kidney Paired Donation Video-Based Education Trial

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ClinicalTrials.gov Identifier: NCT03013829
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center

Brief Summary:
The purpose of this study is to evaluate the effectiveness of a targeted educational approach designed to increase knowledge about the risks and benefits of living donation generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision making about KPD among incompatible or cross-match positive donor-recipient pairs.

Condition or disease Intervention/treatment Phase
Kidney Paired Donation Behavioral: KPD Educational Video Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Kidney Paired Donation: A Randomized Trial to Increase Knowledge and Informed Decision-Making
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
No Intervention: Usual Care
Incompatible potential LKDs and recipients will receive standard-of-care LD (Live Donor) and KPD education. As noted previously, potential LKDs are informed of their incompatibility during a phone call with the donor nurse coordinator. The KPD option is described and the potential LKD is provided with living donation information and a link to the UNOS KPD website, which includes a written description of KPD. This information is available in English and Spanish. For those who do not have internet access, the written educational materials are mailed. The potential LKD is advised to call the donor nurse coordinator with any questions about KPD and/or to initiate the full donation evaluation. This process occurs for the intended recipient only if their potential donor decides to initiate the full evaluation. Incompatible LKDs and recipients assigned to the UC group will be sent an email after randomization, which will include a link and a reminder to visit the UNOS website.
Experimental: Video-Based KPD education
Incompatible LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch the embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.
Behavioral: KPD Educational Video
Incompatible LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch an embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.




Primary Outcome Measures :
  1. Living Donation and KPD Knowledge [ Time Frame: at baseline ]
    A questionnaire will be used to assess living donation and KPD knowledge.

  2. Living Donation and KPD Knowledge [ Time Frame: 2 weeks post-intervention ]
    A questionnaire will be used to assess living donation and KPD knowledge.

  3. Living Donation and KPD Knowledge [ Time Frame: three months post-intervention ]
    A questionnaire will be used to assess living donation and KPD knowledge.


Secondary Outcome Measures :
  1. Living Donation and KPD Concerns [ Time Frame: at baseline ]
    Living donation and KPD concerns will be assessed using a Concerns about Living Donation scale and the Kidney Exchange Concerns (KEC) questionnaire.Questionnaire results will be aggregated to evaluate concerns about living donation and KPD.

  2. Living Donation and KPD Concerns [ Time Frame: 2 weeks post-intervention ]
    Living donation and KPD concerns will be assessed using a Concerns about Living Donation scale and the Kidney Exchange Concerns (KEC) questionnaire. Questionnaire results will be aggregated to evaluate concerns about living donation and KPD.

  3. Informed Decision-Making [ Time Frame: at baseline ]
    The investigators will measure living donation and KPD informed decision-making using five true-false items.

  4. Informed Decision-Making [ Time Frame: 2 weeks post-intervention ]
    The investigators will measure living donation and KPD informed decision-making using five true-false items.

  5. Living Donation and KPD Self-Efficacy [ Time Frame: at baseline ]
    The investigators will assess self-efficacy using a measure developed for the current NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)-funded House Calls RCT. This measure includes a list of actions or behaviors that are related to KPD, to which participants will indicate their level of confidence in carrying them out.

  6. Living Donation and KPD Self-Efficacy [ Time Frame: 2 weeks post-intervention ]
    The investigators will assess self-efficacy using a measure developed for the current NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)-funded House Calls RCT. This measure includes a list of actions or behaviors that are related to KPD, to which participants will indicate their level of confidence in carrying them out.

  7. Living Donation and KPD Discussions [ Time Frame: at baseline ]
    For the House Calls RCT, the investigators developed and validated a measure designed to assess the amount of time individuals spend talking to others about living donation. This measure asks whether the LKD or intended recipient talked to the donor/recipient, family members, friends, or healthcare providers about living donation and KPD, and if so, approximately how much time was spent discussing donation (TALKeD).

  8. Living Donation and KPD Discussions [ Time Frame: 2 weeks post-intervention ]
    For the House Calls RCT, the investigators developed and validated a measure designed to assess the amount of time individuals spend talking to others about living donation. This measure asks whether the LKD or intended recipient talked to the donor/recipient, family members, friends, or healthcare providers about living donation and KPD, and if so, approximately how much time was spent discussing donation (TALKeD).


Other Outcome Measures:
  1. Living donation and KPD Activation- Evaluation of Actions Taken [ Time Frame: three months post-intervention ]
    As part of the final follow-up assessment, the investigators will assess living donation and KPD activation, which asks participants to indicate whether they spoke to the donor/recipient about living donation and KPD, pursued further evaluation for living donation and KPD, entered the KPD registry, and/or donated or received a transplant. Participants will also be asked about reasons for not pursuing further evaluation or not registering for KPD. This outcome will measure action steps taken with regards to living donation and KPD.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

LKDs

  • Speaks English or Spanish
  • Has a valid email address
  • Completed and passed the initial living donation health screening
  • Documented blood group or human leukocyte antigen (HLA) incompatibility with intended recipient
  • Documentation that incompatibility has been communicated to the potential donor by the nurse coordinator.

Exclusion Criteria:

  • Non-directed (i.e., anonymous) potential LKDs
  • Previously undergone donor evaluation
  • Participation in another study to increase knowledge about living donation/LDK Transplant Candidates
  • Speaks English or Spanish
  • Has a valid email address
  • Has a potential LKD who has completed and passed the initial health screening
  • Documented blood group or HLA incompatibility with LKD
  • Documentation that incompatibility has been communicated to the potential donor by the nurse coordinator

Exclusion Criteria:

  • Had a prior LDKT
  • Previously enrolled in a KPD program
  • Previous or current participation in another study to increase knowledge about living donation/LDKT

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): NCT03013829


Contacts
Contact: James R Rodrigue, Ph.D. 617-632-9821 jrrodrig@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: James R. Rodrigue, Ph. D.    617-632-9821    jrrodrig@bidmc.harvard.edu   
Contact: Sarah G. Duncan, B.A.    6176327012    sduncan1@bidmc.harvard.edu   
Principal Investigator: James R. Rodrigue, Ph. D.         
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Derek A. DuBay, M.D    843-792-4003    dubay@musc.edu   
Contact: Tom Morinelli, Ph.D.    843-792-5404    morinelt@musc.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Medical University of South Carolina

Responsible Party: James Rodrigue, Vice Chair of Clinical Research, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03013829     History of Changes
Other Study ID Numbers: 2016P000409
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Rodrigue, Beth Israel Deaconess Medical Center:
Kidney Paired Donation