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

Headache Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304886
• Other study ID #: John Henry study
• Status: Completed
• Start date: February 28, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	On-line questionnaire accuracy for Diagnosing episodic migraine	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	2 -2.5 years