<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/NCT03304886</url>
  </required_header>
  <id_info>
    <org_study_id>John Henry study</org_study_id>
    <nct_id>NCT03304886</nct_id>
  </id_info>
  <brief_title>Assessing the Diagnostic Accuracy of an On-line Questionnaire for Diagnosis of Primary Headache Disorders</brief_title>
  <official_title>Diagnostic Comparison of an Online Questionnaire Versus a Semi-structured Interview for the Diagnosis of Primary Headache Disorders, Using ICHD 3 as the Gold Standard</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      Purpose of the study is to assess the diagnostic accuracy of an on- line questionnaire in&#xD;
      comparison to a semi-structured interview administered by a trained interviewer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The worldwide current gold standard for diagnosing headaches is the International&#xD;
      Classification of Headache Disorders (ICHD 3 beta). Adhering strictly to ICHD criteria has&#xD;
      been problematic for accurately diagnosing patients in the clinic and as for clinical trials.&#xD;
      To address these issues, an online instrument was developed that successfully diagnosis&#xD;
      common primary and secondary headache disorders. In this research Investigator hopes to&#xD;
      demonstrate an on- line questionnaire is non inferior to a semi-structured interview for&#xD;
      accurately diagnosing different types of headaches (for example: episodic migraine vs. non&#xD;
      episodic migraine, chronic migraine vs. non chronic migraine, episodic tension-type vs.&#xD;
      non-episodic tension type, chronic tension-type headache vs. non chronic tension-type&#xD;
      headache, medication overuse headache vs. non medication overuse headache, post traumatic&#xD;
      headache vs. non post traumatic headache).&#xD;
&#xD;
      Participants will be screened by telephone to see if participants meet the criteria for&#xD;
      taking part in this research study. Once participant is deemed eligible,the participants will&#xD;
      then be randomized in a 1:1 ratio to complete either the semi-structured interview over the&#xD;
      phone first and then complete the online questionnaire or vice versa. Study is expected to&#xD;
      enroll 500 participants with headache and healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>On-line questionnaire accuracy for Diagnosing episodic migraine</measure>
    <time_frame>2 -2.5 years</time_frame>
    <description>An on- line questionnaire is non inferior to a semi-structured interview for accurately diagnosing episodic migraine vs non episodic migraine, chronic migraine vs. non chronic migraine. We will compare the 4 primary (chronic and episodic migraine, chronic and episodic tension-type headache) obtained on each of the two evaluations for reliability using recognized statistical tools: This analysis will be conducted by independent reviewers, not the developers of either instrument</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>Headache Disorders</condition>
  <arm_group>
    <arm_group_label>Migraineurs</arm_group_label>
    <description>with a migraine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Participants without migraine</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All race, gender age between 18-65, English speaking selected from community, clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female or male subjects age between age 18-65(inclusive),&#xD;
&#xD;
          2. Subjects must agree to sign online informed consent;&#xD;
&#xD;
          3. Subject must be able to understand and willing to complete both evaluations in English&#xD;
&#xD;
          4. Willing to comply with study instructions.&#xD;
&#xD;
          5. Agree not to Rely or act on any diagnosis given to them in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Presence of Disorders listed in groups 5-13 of The International Headache Society&#xD;
        Classification of Head and Facial Pain (Headache Classification Committee of the&#xD;
        International Headache Society, 2015 except for post traumatic headache and medication&#xD;
        overuse headache);&#xD;
&#xD;
        1a. History of brain tumor, brain surgery&#xD;
&#xD;
        1b. History of brain infection such as meningitis, encephalitis, or meningoencephalitis&#xD;
&#xD;
        1c. History of any significant current or previous brain dysfunction&#xD;
&#xD;
        1d. Regular use of illicit drugs.&#xD;
&#xD;
        2. Known significant medical or psychiatric disease or abnormal laboratory data that would&#xD;
        preclude entry into this study.&#xD;
&#xD;
        3. Subjects with - significant cognitive impairment such as dementia, active psychiatric&#xD;
        disease such as schizophrenia.&#xD;
&#xD;
        4. Subjects with physical limitations to participate in the on-line or phone interview&#xD;
        impossible.&#xD;
&#xD;
        5. Non-English speaking patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Cowan, MD, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University, School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 12, 2020</last_update_submitted>
  <last_update_submitted_qc>October 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Robert Cowan</investigator_full_name>
    <investigator_title>Director and Chief, Division of Headache Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Headache Disorders</mesh_term>
    <mesh_term>Headache Disorders, Primary</mesh_term>
    <mesh_term>Headache</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/NCT03304886
org study id: John Henry study
nct id: NCT03304886
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose of the study is to assess the diagnostic accuracy of an on- line questionnaire in
      comparison to a semi-structured interview administered by a trained interviewer.
The worldwide current gold standard for diagnosing headaches is the International
      Classification of Headache Disorders (ICHD 3 beta). Adhering strictly to ICHD criteria has
      been problematic for accurately diagnosing patients in the clinic and as for clinical trials.
      To address these issues, an online instrument was developed that successfully diagnosis
      common primary and secondary headache disorders. In this research Investigator hopes to
      demonstrate an on- line questionnaire is non inferior to a semi-structured interview for
      accurately diagnosing different types of headaches (for example: episodic migraine vs. non
      episodic migraine, chronic migraine vs. non chronic migraine, episodic tension-type vs.
      non-episodic tension type, chronic tension-type headache vs. non chronic tension-type
      headache, medication overuse headache vs. non medication overuse headache, post traumatic
      headache vs. non post traumatic headache).

      Participants will be screened by telephone to see if participants meet the criteria for
      taking part in this research study. Once participant is deemed eligible,the participants will
      then be randomized in a 1:1 ratio to complete either the semi-structured interview over the
      phone first and then complete the online questionnaire or vice versa. Study is expected to
      enroll 500 participants with headache and healthy controls.
observational model: Case-Control
time perspective: Cross-Sectional
measure: On-line questionnaire accuracy for Diagnosing episodic migraine
time frame: 2 -2.5 years
description: An on- line questionnaire is non inferior to a semi-structured interview for accurately diagnosing episodic migraine vs non episodic migraine, chronic migraine vs. non chronic migraine. We will compare the 4 primary (chronic and episodic migraine, chronic and episodic tension-type headache) obtained on each of the two evaluations for reliability using recognized statistical tools: This analysis will be conducted by independent reviewers, not the developers of either instrument
arm group label: Migraineurs
description: with a migraine
arm group label: Control
description: Participants without migraine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Cowan, MD, FAAN
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Robert Cowan
investigator title: Director and Chief, Division of Headache Medicine
mesh term: Headache Disorders
mesh term: Headache Disorders, Primary
mesh term: Headache
sharing ipd: No