MEDUSA Study - Migraine: Evaluation of Diagnosis, Utilisation of Services and Application
Condition: Migraine; Self-Assessment
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Migraine is a very common condition characterised by frequent severe headaches that are very
      debilitating. Although the frequency and severity does reduce as patient's age, particularly
      above the age of 70, in younger and working age people this condition has a significant
      impact on people's lives. Patients with migraine are typically diagnosed and managed in
      primary care, but can also be treated by neurologists. Recently, NHS England has published
      guidance for clinical staff to optimise patient management: reduce admissions to hospital for
      migraine and improve the setting in which patients are seen. One recommendation is the
      increased use of headache diaries by patients. These may help patients and doctors to improve
      migraine diagnosis and its treatment, for example by identifying if there are triggers for
      getting a migraine attack. With technological advancements, there are now computer/phone
      applications (Apps) that can be used instead of a paper diary. The Curelator N1 Headache App
      is one of such migraine specific Apps. In this study, the investigators aim to evaluate if
      primary care migraine patients are open to using a digital headache diary App, and how
      compliant users of the App will be. The investigators also aim to assess patient feedback on
      the use of the N1 Headache App, and if its use aids them in the management of their migraine.
    

Detailed description: 
      Headaches are one of the most common ailments, and the headache disorder migraine is the
      second leading cause of years lived with disability. Some figures for the UK illustrate the
      extent of the issue: approximately 10 million people aged 15 - 69 live with migraine , and 3
      million workdays are lost every year in to migraine-related absenteeism alone, at a cost of
      almost £4.4 billion. In the UK, the annual primary care consultation rate for headache is 4.4
      per 100 registered patients, of whom 4% are referred to secondary care for further
      assessment. Headache and migraine is the top self-reported chronic condition amongst primary
      care patients. Management, including self-management, of migraine appears to be sub-optimal.
      Compliance with prophylactic therapy is poor with a limited number of patients using
      preventive treatment, even though many do try prophylactic medicines at some stage. After
      diagnosis there is often also a delay before preventive treatment is attempted, and commonly
      only tried once.

      The issues related to migraine are worsening as reported by NHS England and in the national
      media : "NHS England has announced plans aimed at preventing up to 16,500 emergency hospital
      admissions for headaches and migraines each year. Greater use of headache diaries, where
      patients record their symptoms, and faster access to specialist advice for family doctors are
      among the measures intended to reduce the pressure on frontline services."

      Headache diaries can be paper-based or electronic (Applications or Apps), and prospective or
      retrospective. Retrospective diaries are prone to under and overestimation by patients, and
      'gaming' - completing e.g. a month worth of data at the end of that month - is a potential
      issue with prospective paper-based headache diaries. Electronic diaries may therefore offer a
      viable alternative to paper diaries. Numerous migraine diary Apps have been developed in the
      last decade, and some of them were found not user-friendly or did not measure clinically
      relevant outcomes. A more recent review on the topic of digital headache diaries concluded
      that patient and clinically relevant outcome measures for many were Apps were lacking. It is,
      however, recognised that headache diaries can aid patients and clinicians to track the course
      of a headache disorder, help to identify triggers and inform treatment plans. The usefulness
      of health Apps can be measured with a validated Mobile App Rating Scale.

      Study aims and hypothesis

      To assess if a digital headache diary App (Curelator N1 Headache) is an acceptable tool to
      monitor migraine in a cohort of primary care patients diagnosed with/coded for migraine by
      their GP practice. Furthermore, to determine the compliance rates achieved by users of the N1
      Headache App.
    

Intervention name(s): N1-Headache App (by Curelator)
Intervention type(s): Device
Intervention description(s): Digital application allowing patients to monitor their migraines, and to identify triggers and/or protectors for their migraines.
Intervention model: Single Group Assignment
Intervention model description: Prospective cohort study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: migraine; patient diary