xml: <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/NCT06013982</url>
    </required_header>
    <id_info>
      <org_study_id>23-00759</org_study_id>
      <nct_id>NCT06013982</nct_id>
    </id_info>
    <brief_title>Stroke and Anxiety Reduction</brief_title>
    <official_title>Impact of a Structured Anxiety Reduction Program on Anxiety in Patients Who Are Discharged to Home Following an Acute Stroke in an Academic Medical Center</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NYU Langone Health</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this pilot study is to explore the impact that a structured anxiety reduction&#xD;
        intervention program has on patients being discharged to home following an acute stroke in an&#xD;
        academic medical center. Eligible participants will be screened and recruited by the research&#xD;
        team through daily rounds. After completing the informed consent process, the research team&#xD;
        will pull demographic information from the electronic health record (EHR) and REDCAP that&#xD;
        includes ethnicity and support system. Participants will complete the Anxiety Screen&#xD;
        Questionnaire (GAD-7 ANXIETY SURVEY) and will be provided with information regarding stroke&#xD;
        support groups available with additional NYU Langone Health and the American Heart&#xD;
        Association internet-based information regarding anxiety reduction (NYU Langone Health&#xD;
        Anxiety Reduction Bundle). The participants will be encouraged to attend a stroke support&#xD;
        group for 3 months and utilize the NYU Langone Health Anxiety Reduction Bundle provided. At&#xD;
        the completion of the intervention (3 months), participants will be provided with the GAD-7&#xD;
        ANXIETY SURVEY again and a survey that includes open-ended questions and a program evaluation&#xD;
        by email. Analysis will occur after final data is collected.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in GAD-7 Score from Baseline to Month 3</measure>
      <time_frame>Baseline, Month 3</time_frame>
      <description>The GAD-7 Anxiety Questionnaire involves 7 items assessing how often participants have felt bothered by anxiety-related problems over the past two weeks. Each item is rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; where 0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 = severe anxiety.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Acute Stroke</condition>
    <arm_group>
      <arm_group_label>Patients discharged following acute care stroke</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participation will last 3 months from enrollment. Demographic data will be retrieved from the electronic health record and the Generalized Anxiety Disorder-7 (GAD-7) Anxiety Questionnaire will be administered at baseline. Participants will repeat the GAD-7 in 3 months and an additional qualitative survey on their experience including an evaluation of the structured anxiety reduction program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Anxiety Reduction Bundle</intervention_name>
      <description>The Anxiety Reduction Bundle intervention comprises the following resources:&#xD;
  Stroke Support Group&#xD;
  Anxiety Reduction Sheet&#xD;
  Understanding Anxiety Disorder sheet&#xD;
  Your body's response to anxiety sheet&#xD;
  Relaxation Tip sheet&#xD;
  Breathing Tip sheet and video&#xD;
  A sigh of Relief video</description>
      <arm_group_label>Patients discharged following acute care stroke</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be diagnosed with an acute stroke&#xD;
  &#xD;
            -  Able to speak, read and write in English&#xD;
  &#xD;
            -  Not cognitively impaired, as per standard of care documentation in the EHR regarding&#xD;
               mental status.&#xD;
  &#xD;
            -  Discharged to home&#xD;
  &#xD;
            -  Internet access including email&#xD;
  &#xD;
            -  Willingness to participate in an anxiety reduction program&#xD;
  &#xD;
            -  Length of hospital stay less than 5 days from the initial presentation of stroke&#xD;
               symptoms&#xD;
  &#xD;
            -  Must be medically stable&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not diagnosed with an acute stroke&#xD;
  &#xD;
            -  Unable to speak, read and write in English as this intervention is not available in&#xD;
               other languages and at this time, funding is not available in order to have the&#xD;
               resources provided translated or to have translation services available for these&#xD;
               participants.&#xD;
  &#xD;
            -  Not discharged to home&#xD;
  &#xD;
            -  No internet access including email&#xD;
  &#xD;
            -  Unwilling or unable to participate in an anxiety reduction program&#xD;
  &#xD;
            -  Cognitively impaired&#xD;
  &#xD;
            -  Length of hospital stay greater than 6 days from the initial presentation of stroke&#xD;
               symptoms&#xD;
  &#xD;
            -  Not medically stable&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bibi Sangster</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bibi Sangster</last_name>
      <phone>212-263-7744</phone>
      <email>Bibi.Sangster@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kathleen Zavotsky</last_name>
      <phone>212-263-2055</phone>
      <email>Kathleen.zavotsky@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Langone Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</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>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This is a pilot study and the data will need to be evaluated before it is shared.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013982
  org study id: 23-00759
  nct id: NCT06013982
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this pilot study is to explore the impact that a structured anxiety reduction
        intervention program has on patients being discharged to home following an acute stroke in an
        academic medical center. Eligible participants will be screened and recruited by the research
        team through daily rounds. After completing the informed consent process, the research team
        will pull demographic information from the electronic health record (EHR) and REDCAP that
        includes ethnicity and support system. Participants will complete the Anxiety Screen
        Questionnaire (GAD-7 ANXIETY SURVEY) and will be provided with information regarding stroke
        support groups available with additional NYU Langone Health and the American Heart
        Association internet-based information regarding anxiety reduction (NYU Langone Health
        Anxiety Reduction Bundle). The participants will be encouraged to attend a stroke support
        group for 3 months and utilize the NYU Langone Health Anxiety Reduction Bundle provided. At
        the completion of the intervention (3 months), participants will be provided with the GAD-7
        ANXIETY SURVEY again and a survey that includes open-ended questions and a program evaluation
        by email. Analysis will occur after final data is collected.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in GAD-7 Score from Baseline to Month 3
  time frame: Baseline, Month 3
  description: The GAD-7 Anxiety Questionnaire involves 7 items assessing how often participants have felt bothered by anxiety-related problems over the past two weeks. Each item is rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; where 0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 = severe anxiety.
  arm group label: Patients discharged following acute care stroke
  arm group type: Experimental
  description: Participation will last 3 months from enrollment. Demographic data will be retrieved from the electronic health record and the Generalized Anxiety Disorder-7 (GAD-7) Anxiety Questionnaire will be administered at baseline. Participants will repeat the GAD-7 in 3 months and an additional qualitative survey on their experience including an evaluation of the structured anxiety reduction program.
  intervention type: Behavioral
  intervention name: Anxiety Reduction Bundle
  description: The Anxiety Reduction Bundle intervention comprises the following resources:
  Stroke Support Group
  Anxiety Reduction Sheet
  Understanding Anxiety Disorder sheet
  Your body's response to anxiety sheet
  Relaxation Tip sheet
  Breathing Tip sheet and video
  A sigh of Relief video
  arm group label: Patients discharged following acute care stroke
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Bibi Sangster
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Bibi Sangster
  phone: 212-263-7744
  email: Bibi.Sangster@nyulangone.org
  last name: Kathleen Zavotsky
  phone: 212-263-2055
  email: Kathleen.zavotsky@nyulangone.org
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: No
  ipd description: This is a pilot study and the data will need to be evaluated before it is shared.