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

NCT ID: NCT03304886

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-12-30

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.

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.

Conditions

Headache Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Migraineurs

with a migraine

No interventions assigned to this group

Control

Participants without migraine

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Robert Cowan

Director and Chief, Division of Headache Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Cowan, MD, FAAN

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Countries

United States

References

DeSouza DD, Woldeamanuel YW, Sanjanwala BM, Bissell DA, Bishop JH, Peretz A, Cowan RP. Altered structural brain network topology in chronic migraine. Brain Struct Funct. 2020 Jan;225(1):161-172. doi: 10.1007/s00429-019-01994-7. Epub 2019 Dec 2.

Reference Type: DERIVED

PMID: 31792696 (View on PubMed)

Other Identifiers

John Henry study

Identifier Type: -

Identifier Source: org_study_id