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Social Networks and Renal Education: Promoting Transplantation (SNARE)

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ClinicalTrials.gov Identifier: NCT03536858
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Temple University

Brief Summary:
There are significant and persistent disparities in access to kidney transplantation and as a result most patients with end stage renal disease receive hemodialysis (HD). HD is unique as it is a treatment performed in a group setting which lends itself to forming social networks. The goal of this research study is to identify and characterize the social networks of HD patients and measure the influence of HD social networks on knowledge, attitudes, and behaviors towards transplantation using repeated surveys and a network targeted educational intervention.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Living Donor Kidney Transplantation Renal Dialysis Behavioral: COACH (Communicating about Choices in Transplantation) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators will assign every HD clinic shift to one of the two targeting strategies. They will measure the spread of information, attitudes, and behaviors by comparing the patients targeted to participate in the living donor intervention to the other patients on their shift.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Hemodialysis staff will be unaware as to whether the patient was targeted based on their network centrality or clustering. Survey administrators will be unaware of which patient received the living donor intervention.
Primary Purpose: Other
Official Title: Social Networks and Renal Education: Promoting Transplantation
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Centrality
The patients at clinic one who receive hemodialysis on Tuesday, Thursday, Saturday and the patients on the Monday, Wednesday, Friday schedule at clinic two, will be assigned to the Centrality arm. Two patients per hemodialysis shift with the highest centrality will be selected to participate in the COACH (Communicating about Choices in Transplantation) intervention. The patients selected by centrality will have a centrality greater than 1 standard deviation (SD) from the mean of the other patients on their hemodialysis clinic shift and a clustering less than 1 SD from the mean. The investigators will measure the spread of information, attitudes, and behaviors by comparing the targeted patients to the other patients on their shift.
Behavioral: COACH (Communicating about Choices in Transplantation)
COACH is a behavioral communication intervention designed specifically for ESRD patients pursuing kidney transplantation. The COACH program consists of four modules: 1) Kidney transplant options, 2) Discussing your transplant options, 3) Requesting living donation, and 4) Maintaining positive relationships. The content and teaching strategies were guided by the concepts of social cognitive theory as well as principles of adult learning and communication skill acquisition. We believe that patients will transfer these skills to other patients at the hemodialysis clinic who are on their shift.

Active Comparator: Clustering
The patients at clinic one who receive hemodialysis on Monday, Wednesday, Friday and the patients on the Tuesday, Thursday, Saturday schedule at clinic two, will be assigned to the Clustering arm.Two patients per hemodialysis shift with the highest clustering coefficient will be selected to participate in the COACH (Communicating about Choices in Transplantation) intervention. The patient selected by clustering coefficient, will have a clustering coefficient greater than 1 SD from the mean of the other patients on their hemodialysis clinic shift and centrality 1 SD less than a mean. The investigators will measure the spread of information, attitudes, and behaviors by comparing the targeted patients to the other patients on their shift.
Behavioral: COACH (Communicating about Choices in Transplantation)
COACH is a behavioral communication intervention designed specifically for ESRD patients pursuing kidney transplantation. The COACH program consists of four modules: 1) Kidney transplant options, 2) Discussing your transplant options, 3) Requesting living donation, and 4) Maintaining positive relationships. The content and teaching strategies were guided by the concepts of social cognitive theory as well as principles of adult learning and communication skill acquisition. We believe that patients will transfer these skills to other patients at the hemodialysis clinic who are on their shift.




Primary Outcome Measures :
  1. Primary Knowledge Outcome: Differences in patient knowledge 3 months post-intervention [ Time Frame: Baseline to 3 months post intervention ]
    The investigators will compare the differences in patient transplant knowledge three months post intervention to baseline knowledge. The investigators will compare survey questionnaire answers collected three months post-intervention to those collected pre-intervention. The investigators will use twelve true/false items on transplant knowledge items, summing the correctly answered items to create a composite knowledge score. The higher the composite score the greater the knowledge.

  2. Primary Knowledge Outcome: Differences in patient knowledge 1 year post-intervention [ Time Frame: Baseline to 1 year post intervention ]
    The investigators will compare the differences in patient knowledge regarding transplant one year post intervention to baseline knowledge. The investigators will compare survey questionnaire answers collected one year post-intervention to those collected pre-intervention. They investigators will use twelve true/false items on transplant knowledge items summing the correctly answered items to create a composite knowledge score. The higher the composite score the greater the knowledge.

  3. Primary Behavioral Outcome: Differences in transplant steps completed 3 months post-intervention [ Time Frame: Baseline to 3 months post intervention ]
    The investigators will measure the number of transplant steps completed. The investigators will measure the difference in the transplant step at three months and one year post intervention and compare that to the step prior to the intervention. The steps towards transplant include: 1) transplant suitability for referral to transplant center, 2) interest in transplantation, 3) referral call to transplant center, 4) first visit to transplant center, 5) transplant center work-up, 6) work-up complete, 7) active on the list, 8) successfully received a kidney transplant. A larger number indicates more steps completed.

  4. Primary Behavioral Outcome: Differences in transplant steps completed 1 year post-intervention [ Time Frame: Baseline to 1 year post intervention ]
    The investigators will measure the number of transplant steps completed. The investigators will measure the difference in the transplant step at three months and one year post intervention and compare that to the step prior to the intervention. The steps towards transplant include: 1) transplant suitability for referral to transplant center, 2) interest in transplantation, 3) referral call to transplant center, 4) first visit to transplant center, 5) transplant center work-up, 6) work-up complete, 7) active on the list, 8) successfully received a kidney transplant. A larger number indicates more steps completed.


Secondary Outcome Measures :
  1. Completion of transplant work-up 3 months post intervention [ Time Frame: 3 months post intervention ]
    The investigators will confirm with the hemodialysis clinic and the transplant center whether the patient has successfully completed the kidney transplant work-up. This is a binary outcome and will be measured three months.

  2. Completion of transplant work-up 1 year post intervention [ Time Frame: 1 year post intervention ]
    The investigators will confirm with the hemodialysis clinic and the transplant center whether the patient has successfully completed the kidney transplant work-up. This is a binary outcome one year post intervention.

  3. Asking for a living donor 3 months post-intervention [ Time Frame: 3 months post intervention ]
    The investigators will measure patient self-reported requests for living donation, including the number of requests. This will be measured by survey questionnaire three months post intervention

  4. Asking for a living donor 1 year post-intervention [ Time Frame: 1 year post intervention ]
    The investigators will measure patient self-reported requests for living donation, including the number of requests. This will be measured by survey questionnaire one year post intervention



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:   No
Criteria

Inclusion Criteria:

  • All patients 18 years of age or older, able to consent to participation and respond to the validated survey in English, and who are present in the HD clinics during the initial survey periods, July 2018 to November 2018 are eligible to participate in the baseline network survey.
  • Transplant eligible patients will be eligible to participate. All patients who participate will be evaluated via chart review by a study transplant nephrologist for transplant candidacy and, if eligible, the primary nephrologist will be asked whether the patient is an appropriate candidate and reasons they have not been referred. We will defer the transplant referral to the attending nephrologist. Our criteria for transplant ineligibility are nursing home resident, >79 years of age, active or recent malignancy, inoperable coronary artery disease, or comorbid illness that will make it unlikely that the patient will survive >3 years after transplant.

Exclusion Criteria:

  • Patients who are unable or unwilling to provide consent or complete the survey in English .

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): NCT03536858


Contacts
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Contact: Avrum Gillespie, MD 2157077937 avrum.gillespie@tuhs.temple.edu
Contact: Crystal Gadegbeku, MD 2157079171 Crystal.Gadegbeku@tuhs.temple.edu

Locations
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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Avrum Gillespie    215-707-7937    avrum.gillespie@tuhs.temple.edu   
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Avrum Gillespie Temple University Hospital
  Study Documents (Full-Text)

Documents provided by Temple University:
Study Protocol  [PDF] April 3, 2017
Statistical Analysis Plan  [PDF] April 3, 2017


Publications:
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03536858     History of Changes
Other Study ID Numbers: 11648
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once the final analysis is completed. De-identified data will be available on request from the investigator once proper institutional review board application has been confirmed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple University:
End Stage Renal Disease
Hemodialysis
Social Network
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency