<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02190955</url>
  </required_header>
  <id_info>
    <org_study_id>6802</org_study_id>
    <nct_id>NCT02190955</nct_id>
  </id_info>
  <brief_title>Assessment of the Educational Experiences for Patients Newly Diagnosed With Nephrotic Syndrome</brief_title>
  <official_title>Assessment of the Educational Experience for Patients With Newly Diagnosed Nephrotic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maine Medical Partners</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>C.S. Mott Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn about patient, caregiver and healthcare worker&#xD;
      perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients&#xD;
      enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to&#xD;
      participate in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The survey included questions addressing the following areas: 1.) Information that is&#xD;
      important to know when learning to manage Nephrotic Syndrome. 2.) Preferred resources for the&#xD;
      education of patients and caregivers with newly-diagnosed Nephrotic Syndrome. 3.) The time&#xD;
      frame required to acquire confidence in the management of Nephrotic Syndrome. 4.)&#xD;
      Disease-specific information such as diagnosis, length of disease duration, medications used,&#xD;
      need for kidney biopsy, dialysis and/or transplant. 5.) Demographic data such as&#xD;
      race/ethnicity and educational background.&#xD;
&#xD;
      The survey data is stored by the Rare Diseases Clinical Research Network's Data Management&#xD;
      and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified.&#xD;
      Names or other personal health information were not collected. Upon conclusion of the study&#xD;
      period, the data will be sent to the NEPTUNE consortium lead at the University of Michigan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients</measure>
    <time_frame>1 year after the study is closed to enrollment</time_frame>
    <description>The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome</measure>
    <time_frame>1 year after the study is closed to enrollment</time_frame>
    <description>The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">186</enrollment>
  <condition>Nephrotic Syndrome</condition>
  <arm_group>
    <arm_group_label>NEPTUNE contact registry patients</arm_group_label>
    <description>Patients and caregivers will be recruited from the Nephrotic Syndrome Study Network (NEPTUNE) Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and have already provided permission to be contacted for future research studies. Analysis of the one-time online questionnaire will be done in collaboration with investigators from the NEPTUNE Consortium.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients and caregivers were recruited from the Nephrotic Syndrome Study Network (NEPTUNE)&#xD;
        Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and&#xD;
        have already provided permission to be contacted for future research studies. The Contact&#xD;
        Registry was created to inform patients and/or parents of patients with Nephrotic Syndrome&#xD;
        of clinical research studies.&#xD;
&#xD;
        Health professionals, including pediatric and internal medicine nephrologists and&#xD;
        nephrology nurses will be recruited from the 18 NEPTUNE study network sites.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient and Patient Caregiver:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  English literate&#xD;
&#xD;
          -  History of Nephrotic Syndrome &gt; 3 months or caregiver of a child diagnosed with&#xD;
             Nephrotic Syndrome &gt; 3 months prior to enrollment&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
        Healthcare Worker Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  English literate&#xD;
&#xD;
          -  Provides medical care for children or adults with Nephrotic Syndrome&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent and complete survey&#xD;
&#xD;
          -  Other criteria as specified by Consortium and based on the data we collect in the&#xD;
             Contact Registry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Tanzer, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Maine Medical Partners</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Debbie Gipson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>C.S. Mott Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Florida Data Management and Coordinating Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>May 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephrotic Syndrome</mesh_term>
    <mesh_term>Nephrosis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02190955
org study id: 6802
nct id: NCT02190955
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to learn about patient, caregiver and healthcare worker
      perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients
      enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to
      participate in this study.
The survey included questions addressing the following areas: 1.) Information that is
      important to know when learning to manage Nephrotic Syndrome. 2.) Preferred resources for the
      education of patients and caregivers with newly-diagnosed Nephrotic Syndrome. 3.) The time
      frame required to acquire confidence in the management of Nephrotic Syndrome. 4.)
      Disease-specific information such as diagnosis, length of disease duration, medications used,
      need for kidney biopsy, dialysis and/or transplant. 5.) Demographic data such as
      race/ethnicity and educational background.

      The survey data is stored by the Rare Diseases Clinical Research Network's Data Management
      and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified.
      Names or other personal health information were not collected. Upon conclusion of the study
      period, the data will be sent to the NEPTUNE consortium lead at the University of Michigan.
observational model: Cohort
time perspective: Cross-Sectional
measure: Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients
time frame: 1 year after the study is closed to enrollment
description: The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
measure: Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome
time frame: 1 year after the study is closed to enrollment
description: The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
arm group label: NEPTUNE contact registry patients
description: Patients and caregivers will be recruited from the Nephrotic Syndrome Study Network (NEPTUNE) Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and have already provided permission to be contacted for future research studies. Analysis of the one-time online questionnaire will be done in collaboration with investigators from the NEPTUNE Consortium.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Tanzer, MD
role: Study Chair
affiliation: Maine Medical Partners
last name: Debbie Gipson, MD
role: Study Chair
affiliation: C.S. Mott Children's Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nephrotic Syndrome
mesh term: Nephrosis
mesh term: Syndrome