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CompletedNCT05979285MEDUSAUpdated Aug 7, 2023

MEDUSA Study - Migraine: Evaluation of Diagnosis, Utilisation of Services and Application

An interventional study of N1-Headache App (by Curelator) in Migraine and Self-Assessment, sponsored by Cumbria Partnership NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Cumbria Partnership NHS Foundation Trust · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Oct 2020, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
887
Allocation
Not applicable
Ages
16 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Migraine
  • Self-Assessment

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Keywords

  • migraine
  • patient diary
03

In context

Migraine Disorders

1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.

This study's enrollment of 887 is above the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Cumbria Partnership NHS Foundation Trust is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
887 participants (actual)

Study arms

  • Experimental
    N1-Headache App

    All participants used the N1-HEadache App, a digital migraine diary that allows identification of triggers/protectors for migraine (as well as monitoring of medication use)

    Device: N1-Headache App (by Curelator)

Interventions

  • DeviceN1-Headache App (by Curelator)

    Digital application allowing patients to monitor their migraines, and to identify triggers and/or protectors for their migraines.

06

What researchers measure

Primary outcomes

  1. patient interest in N1 Headache App

    percentage of survey responders who indicate they are willing to trial the N1 Headache App

    Time frame: 30 days

  2. user compliance for N1 Headache App

    percentage of participants who consent to using the App who comply with daily use in 90 day trial period

    Time frame: 90 days

Secondary outcomes

  1. previous use of digital diary Apps for migraine

    what percentage of responders has previously used a digital diary App for migraine

    Time frame: 30 days

  2. usefulness of N1 Headache App: percentage patients who identify a migraine trigger

    What percentage of patients who use the N1 Headache App often enough do identify a migraine trigger when a report is generated

    Time frame: 90 days

  3. Health Confidence and digital diary App

    Does use of digital diary App for migraine affect patients' HEalth Confidence Score (Degree of agreeableness with statement 'I know enough about my migraine health', answers being 'disagree', 'neutral', 'agree' and 'strongly agree'

    Time frame: 90 days

07

Study locations

1 site
  • Research & Development Department
    Carlisle, Cumbria CA1 3SX, United Kingdom
08

References and documents

Publications

  • 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. PubMed 35364371 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05979285
Lead sponsor
Cumbria Partnership NHS Foundation Trust
Responsible party
Sponsor
First posted
Aug 7, 2023
Start date
Oct 15, 2020
Primary completion
Jul 31, 2021
Completion
Dec 20, 2021
Last update
Aug 7, 2023

Study contacts

Stacey J Fisher, MD
principal investigator · substantive employee

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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