Headache Diary for Migraine Patients

July 17, 2026 updated by: Hackensack Meridian Health

Use of a Headache Calendar/Journal in Patients Who Have Migraine

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Hackensack Meridian Health - JFK Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Headache diary
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
Completion of the virtual diary/calendar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine Specific Quality of Life
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine Disability Assessment (MIDAS) score
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
To determine whether headache burden has decreased, as measured by the Migraine Disability Assessment (MIDAS). MIDAS is a standard questionnaire used by neurologists and primary care providers to measure how severely migraines impact your daily life and work capacity. Scores range from 0 (no disability) to 21+ (severe disability) based on the number of days from a migraine event.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Investigators

  • Principal Investigator: Brian Gerhardstein, MD, MPH, Hackensack Meridian Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2024-0201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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