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Social Networks and Renal Education: Promoting Transplantation (SNARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536858
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE October 23, 2018
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Networks and Renal Education: Promoting Transplantation
Official Title  ICMJE Social Networks and Renal Education: Promoting Transplantation
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.
Detailed Description

Kidney transplantation is the treatment of choice for end stage renal disease (ESRD). Unfortunately, there are significant and persistent gender and racial disparities in access to transplantation and the successful navigation of transplant evaluation process. The process includes understanding suitability/eligibility for transplantation, obtaining a referral to a transplant center for medical evaluation, completion of medical testing for transplant candidacy, and asking family and friends to donate. Women and ethnic minorities are less likely to be informed of the option of transplantation, referred to a transplant center, and complete the medical evaluation needed to be placed on the kidney transplant waiting list. Modifiable barriers to completing these steps include: lack of knowledge, lack of social support, and inability to discuss transplantation and living donation. As a result chronic hemodialysis (HD) becomes the default treatment. HD clinics are unique social environments in that patients receive their treatments in a group setting which facilitates social networks and the formation of unique micro-communities based on their assigned shift. The robust influences of social networks are well-described in other chronic conditions like obesity, diabetes, and smoking, however, there is scant information on the impact of social networks in HD clinics. Differences in social network structure by gender and race may create critical barriers in the kidney transplant process. White men tend to have diffuse networks which are better for communicating novel information. Women and minorities tend to have clustered/dense networks, which tend to reinforce attitudes and behaviors. It has been speculated that social networks negatively affect transplantation through the clustering of inaccurate information, negative attitudes, and exposure to failed transplants. Our previous observational research, however, suggests that HD patient social network structure can facilitate the completion of pre-transplant steps by providing patients with needed information and support. Further insight into HD social networks has the potential to guide measures to reduce transplant disparities. Our overarching hypothesis is that hemodialysis social networks facilitate the spread of information and behaviors, and that using a targeted social network intervention will improve access to transplantation especially among women and minorities. To address this hypothesis, we will pursue the following specific aims:

Aim 1: Characterize hemodialysis patient social networks by gender and race. Using our previously validated survey, we will model social networks of hemodialysis patients in two independent clinics.

Hypothesis 1: Female hemodialysis patients of all race and ethnicity have dense (higher clustering coefficient) social networks when compared to male HD patients.

Aim 2: Assess the relationship between network structure and knowledge, attitudes, and behaviors towards kidney transplantation. Using the network information from Aim 1, we will analyze the clustering of information, attitudes, and behaviors towards kidney transplantation.

Hypothesis 2: Patients in dense HD clinic social networks have similar attitudes (both positive and negative) about transplantation and behaviors (initiating transplant discussion and completing steps in the kidney transplant process) as compared to patients in diffuse networks.

Aim 3: Compare and contrast the diffusion of knowledge, attitudes, and behaviors regarding transplantation through HD social networks by targeting either the most clustered (as measured by clustering coefficient) or the most central members (as measured by betweenness centrality) of the network to disseminate a transplant education intervention. We will assign every HD clinic shift to one of the two targeting strategies and we will measure the spread of information, attitudes, and behaviors by comparing the targeted patients to the other patients on their shift.

Hypothesis 3: Targeting patients with high clustering coefficient will be the most effective method to spread information and favorable attitudes toward transplantation, as well as completion of steps toward transplantation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • End Stage Renal Disease
  • Living Donor Kidney Transplantation
  • Renal Dialysis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: COACH (Communicating about Choices in Transplantation)
  • 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.
    Intervention: Behavioral: COACH (Communicating about Choices in Transplantation)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2020)
125
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
255
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Avrum Gillespie, MD 2157077937 avrum.gillespie@tuhs.temple.edu
Contact: Crystal Gadegbeku, MD 2157079171 Crystal.Gadegbeku@tuhs.temple.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03536858
Other Study ID Numbers  ICMJE 11648
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: 7/2023
Access Criteria: Proposal from researcher
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avrum Gillespie Temple University Hospital
PRS Account Temple University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP