Clinical trial NCT05979285: MEDUSA Study - Migraine: Evaluation of Diagnosis, Utilisation of Services and Application
Official title: Evaluation of Patient Experiences of Migraine Management and Feasibility of a Digital Headache Diary in Primary Care Setting: a Prospective Cohort Survey and Evaluative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Self-Assessment
Keywords: migraine
patient diary
Lead sponsor: Cumbria Partnership NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 887
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* • Primary care patients diagnosed with or attending their GP practice ('coded for') migraine in the last 5 years. This may therefore be newly diagnosed patients or patients with long-standing migraine who attended their GP practice about their condition.

  * Patients aged ≥ 16 years
  * Mental capacity to give consent and not using an interpreter for GP consultations (ie competent in English and capacity to complete postal survey)
  * Part 2 only:

    * Completion of complete part 1 survey, including indication that patient still has ongoing migraine issues.
    * Access to email, internet and Apple or Android technology (ie smartphone, tablet or computer)

Exclusion Criteria:

* • Under the age of 16 years

  * Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
  * The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise their capacity to complete the survey. Examples would be current severe ill health episode.

Primary outcomes:
measure: patient interest in N1 Headache App
timeFrame: 30 days
measure: user compliance for N1 Headache App
timeFrame: 90 days
Secondary outcomes:
measure: previous use of digital diary Apps for migraine
timeFrame: 30 days
measure: usefulness of N1 Headache App: percentage patients who identify a migraine trigger
timeFrame: 90 days
measure: Health Confidence and digital diary App
timeFrame: 90 days
Other outcomes:
Locations:
city: Carlisle
country: United Kingdom
facility: Research & Development Department
state: Cumbria
Study officials:
affiliation: substantive employee
name: Stacey J Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jonker L, Fitzgerald L, Vanderpol J, Fisher S. Digital diary App use for migraine in primary care: Prospective cohort study. Clin Neurol Neurosurg. 2022 May;216:107225. doi: 10.1016/j.clineuro.2022.107225. Epub 2022 Mar 25.