Headache Diary for Migraine Patients

ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Individuals under the age of 18

Non-English speaking individuals

Trial design

Design model

Single group

Treatments tested in this trial

  • Headache diary

    Behavioral

    Completion of the virtual diary/calendar

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Headache diaryExperimental treatment 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

Migraine Disability Assessment (MIDAS) score

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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