<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/NCT02978729</url>
  </required_header>
  <id_info>
    <org_study_id>824225</org_study_id>
    <nct_id>NCT02978729</nct_id>
  </id_info>
  <brief_title>Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial</brief_title>
  <acronym>CONNECT4APOE</acronym>
  <official_title>A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two methods for remote genetic counseling (telephone&#xD;
      and two-way videoconferencing) for patients who are receiving disclosure of their APOE&#xD;
      (apolipoprotein E) genotype. The target population will consist of males and females in the&#xD;
      age range of 60-75 years who, as potential participants in a study (Generation Study), will&#xD;
      need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing&#xD;
      to receive genetic counseling and disclosure remotely. Subjects must be willing to be&#xD;
      randomized to either telephone arm or videoconference arm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">July 11, 2019</completion_date>
  <primary_completion_date type="Actual">July 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale</measure>
    <time_frame>2-7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale</measure>
    <time_frame>2-7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale</measure>
    <time_frame>2-7 days, 6 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific distress as measured by the Impact of Events Scale</measure>
    <time_frame>2-7 days, 6 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms</measure>
    <time_frame>2-7 days, 6 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale</measure>
    <time_frame>2-7 days, 6 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression as measured by the GDS Short Form</measure>
    <time_frame>2-7 days, 6 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):</measure>
    <time_frame>2-7 days, 6 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale</measure>
    <time_frame>2-7 days, 6 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">613</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Genetic Predisposition to Disease</condition>
  <arm_group>
    <arm_group_label>Telephone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telephone telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via telephone. The participant will be in a private room at the study site. Telephone sessions will utilize a private phone line. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Videoconference</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two-way videoconferencing telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via two-way videoconferencing. The participant will be in a private room at the study site. Videoconferencing sessions will utilize tablets or laptops with web cameras and secure/confidential software for teleconferencing. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Two-way videoconference remote genetic counseling</intervention_name>
    <arm_group_label>Videoconference</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telephone remote genetic counseling</intervention_name>
    <arm_group_label>Telephone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Eligible to participate in the Generation Study&#xD;
&#xD;
          2. Ability to provide consent&#xD;
&#xD;
          3. Ability to communicate and hear in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela R Bradbury, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Counseling, Genetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Genetic Predisposition to Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02978729
org study id: 824225
nct id: NCT02978729
lead sponsor: 
has dmc: No
The purpose of this study is to compare two methods for remote genetic counseling (telephone
      and two-way videoconferencing) for patients who are receiving disclosure of their APOE
      (apolipoprotein E) genotype. The target population will consist of males and females in the
      age range of 60-75 years who, as potential participants in a study (Generation Study), will
      need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing
      to receive genetic counseling and disclosure remotely. Subjects must be willing to be
      randomized to either telephone arm or videoconference arm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
time frame: 2-7 days
measure: Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale
time frame: 2-7 days
measure: Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale
time frame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Disease-specific distress as measured by the Impact of Events Scale
time frame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms
time frame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale
time frame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Depression as measured by the GDS Short Form
time frame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):
time frame: 2-7 days, 6 weeks, 6 months, 12 months
measure: Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale
time frame: 2-7 days, 6 weeks, 6 months, 12 months
arm group label: Telephone
arm group type: Active Comparator
description: Telephone telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via telephone. The participant will be in a private room at the study site. Telephone sessions will utilize a private phone line. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.
arm group label: Videoconference
arm group type: Experimental
description: Two-way videoconferencing telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via two-way videoconferencing. The participant will be in a private room at the study site. Videoconferencing sessions will utilize tablets or laptops with web cameras and secure/confidential software for teleconferencing. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.
intervention type: Other
intervention name: Two-way videoconference remote genetic counseling
arm group label: Videoconference
intervention type: Other
intervention name: Telephone remote genetic counseling
arm group label: Telephone
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Angela R Bradbury, MD
role: Principal Investigator
affiliation: University of Pennsylvania
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Genetic Predisposition to Disease
sharing ipd: No