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Assessing the Diagnostic Accuracy of an On-line Questionnaire for Diagnosis of Primary Headache Disorders

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03304886
Collaborator
(none)
250
Enrollment
1
Location
22
Actual Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    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
    Actual Study Start Date :
    Feb 28, 2018
    Actual Primary Completion Date :
    Oct 30, 2019
    Actual Study Completion Date :
    Dec 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Migraineurs

    with a migraine
    Control

    Participants without migraine

    Outcome Measures

    Primary Outcome Measures

    1. On-line questionnaire accuracy for Diagnosing episodic migraine [2 -2.5 years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Female or male subjects age between age 18-65(inclusive),

    2. Subjects must agree to sign online informed consent;

    3. Subject must be able to understand and willing to complete both evaluations in English

    4. Willing to comply with study instructions.

    5. Agree not to Rely or act on any diagnosis given to them in the study

    Exclusion Criteria:
    1. Presence of Disorders listed in groups 5-13 of The International Headache Society Classification of Head and Facial Pain (Headache Classification Committee of the International Headache Society, 2015 except for post traumatic headache and medication overuse headache);

    1a. History of brain tumor, brain surgery

    1b. History of brain infection such as meningitis, encephalitis, or meningoencephalitis

    1c. History of any significant current or previous brain dysfunction

    1d. Regular use of illicit drugs.

    1. Known significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.

    2. Subjects with - significant cognitive impairment such as dementia, active psychiatric disease such as schizophrenia.

    3. Subjects with physical limitations to participate in the on-line or phone interview impossible.

    4. Non-English speaking patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University, School of Medicine Palo Alto California United States 94304

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Robert Cowan, MD, FAAN, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Cowan, Director and Chief, Division of Headache Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03304886
    Other Study ID Numbers:
    • John Henry study
    First Posted:
    Oct 9, 2017
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Headache Disorders
    Headache Disorders, Primary
    Headache

    Study Results

    No Results Posted as of Oct 14, 2020