Headache is one of the main reasons for seeking primary health care and an important cause of
absenteeism at work and decreased quality of life in the population, being the major
neurological cause of disability in young adults and middle-aged adults. Although the
subjectivity of the complaints and the great intra and inter-individual variability of
clinical presentations hinder its epidemiological study, it is estimated that the overall
prevalence of headache throughout life is 66% (46-78% in tension-type headache; 14-16% for
migraine and 0.1-0.3% for cluster headache). Migraine, in particular, is a primary headache
with an estimated prevalence of 11 to 14% in adult women and 4 to 9% in adult men. In
addition, it is assumed that up to 20% of absences from work can be attributed to headaches,
with the inherent socio-economic impacts.
Headache is a very frequent complaint in the primary care setting. However, the differential
diagnosis can be complicated at this level. Primary headache diagnosis is made almost
exclusively through clinical history taking, for this purpose clinicians use the criteria in
the International Classification of Headache Disorders, currently on its 3rd version.
However, its application is often challenging and time-consuming, especially in a primary
care setting, where physicians are very limited on time. Nonetheless, a correct diagnosis is
essential, as treatment varies among the primary headaches and also within the same headache
type according to its frequency.
The episodic nature of headaches increases the risk of memory bias towards more severe or
more recent crises. To avoid this, patients nowadays use a paper calendar. This calendar
makes it possible to monitor, more reliably, the response to therapy and to identify the need
for any adjustments.
However, the paper calendar has many limitations, such as the possibility of filling in
immediately before consultations instead of non-biased daily records. In addition, the paper
or card used can be lost, is more easily forgotten, and cannot be consulted remotely by the
attending physician. In the current digital landscape, we have seen a transition in
registration methods for semi-automated electronic platforms, considered more practical and
appealing to users. However, most in-app headache diaries are not validated and are mainly
written in English.
Having these ideas in mind the investigators decided to develop an app-based electronic
headache diary that would not only permit a better adhesion to follow-up but also remote
monitoring of headache patients. To study the applicability and the usefulness of this idea
the investigators designed a randomized clinical trial with a crossover design where episodic
migraine patients would be randomized to the use of the app or of a paper headache diary.
Each patient would use the app and the paper diary for a period of 13 weeks.
In the paper and electronic diary patients will record headache days, headache type (migraine
or tension-type headache), headache intensity with a scale from 0 to 10, intake of acute
headache medication, missing work days due to headache, and recurrence to the emergency
department due to headache.
The investigators will also measure headache burden with the portuguese versions of HIT-6,
MSQ v2.1 and MiDAS scales and quality of life with the WHOQOL-BREF at the beginning, at the
crossover point, and at the end of the study. Also, the study will evaluate prophylactic
medication compliance at the beginning, at the crossover point, and at the end of the study
through a questionnaire. User preference will be measured through a questionnaire, using a
Likert type scale, at the end of the study.