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

This study is not yet open for participant recruitment.
Verified October 2017 by Robert Cowan, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03304886
First Posted: October 9, 2017
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Cowan, Stanford University
  Purpose
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
Headache Disorders

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Robert Cowan, Stanford University:

Primary Outcome Measures:
  • On-line questionnaire accuracy for Diagnosing episodic migraine [ Time Frame: 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


Estimated Enrollment: 500
Anticipated Study Start Date: November 15, 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Migraineurs
with a migraine
Control
Participants without migraine

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All race, gender age between 18-65, English speaking selected from community, clinic.
Criteria

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.

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

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

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

5. Non-English speaking patients

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304886


Contacts
Contact: Bharati Sanjanwala, M. Sc. 650-721-2830 bharatis@stanford.edu
Contact: Anthony Bet, B.S. 650-497-5714 abet0915@stanford.edu

Locations
United States, California
Stanford University, School of Medicine Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Bharati Sanjanwala    650-721-2830    bharatis@stanford.edu   
Contact: Anthony Bet    650-497-5714    abet0915@stanford.edu   
Principal Investigator: Robert Cowan, MD, FAAN         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert Cowan, MD, FAAN Stanford University
  More Information

Responsible Party: Robert Cowan, Director and Chief, Division of Headache Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03304886     History of Changes
Other Study ID Numbers: John Henry study
First Submitted: October 4, 2017
First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Disease
Headache
Headache Disorders
Headache Disorders, Primary
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases