Headache Diary for Migraine Patients

NCT07698249 | Enrolling By Invitation

• 1 other identifier: Pro2024-0201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Use of a headache journal/calendar in patients who have migraine to ascertain if keeping a headache journal affects the quality of life and the headache burden.

Conditions

Migraine

Keywords

migraine; diary; calendar

Outcome Measures

Primary Outcomes (1)

• Migraine Specific Quality of Life

  Migraine Specific Quality of Life using the MSQv2.1, a 14-item validated assessment used to measure how migraines affect a patient's daily functioning and well-being. Each of the 14 questions is scored using a 6-point scale ranging from 1 ("Always") to 6 ("Never"). The raw scores for each of the three domains are transformed into a standardized 0 to 100 scale, where higher scores indicate a better quality of life (less impact/disability from migraine).

  Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Secondary Outcomes (1)

• Migraine Disability Assessment (MIDAS) score

  Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Study Arms (1)

Headache diary

EXPERIMENTAL

Virtual headache calendar/journal is given to migraine patients to see if it affects their migraine burden. Surveys are completed virtually at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks.

Behavioral: Headache diary

Interventions

Headache diary BEHAVIORAL

Completion of the virtual diary/calendar

Headache diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults diagnosed with migraine (episodic or chronic) according to ICHD-3 criteria, with at least 3 months of confirmed diagnosis. Both episodic migraine (≤14 headache days/month) and chronic migraine (≥15 headache days/month) are eligible and will be recorded as a demographic subgroup variable.

You may not qualify if:

• Individuals under the age of 18
• Non-English speaking individuals

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Meridian Health - JFK Medical Center

Edison, New Jersey, 08820, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Brian Gerhardstein, MD, MPH

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 14, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)