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

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Self-Assessment
• Intervention / Treatment: Device: N1-Headache App (by Curelator)

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.

• Study Type: Interventional
• Enrollment (Actual): 887
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Digital application allowing patients to monitor their migraines, and to identify triggers and/or protectors for their migraines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient interest in N1 Headache App	percentage of survey responders who indicate they are willing to trial the N1 Headache App	30 days
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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
previous use of digital diary Apps for migraine	what percentage of responders has previously used a digital diary App for migraine	30 days
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	90 days
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'	90 days

Collaborators and Investigators

• Sponsor: Cumbria Partnership NHS Foundation Trust
• Investigators: Principal Investigator: Stacey J Fisher, MD, substantive employee

Publications and helpful links

General 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 Mar 25;216:107225. doi: 10.1016/j.clineuro.2022.107225. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: migraine; patient diary
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: MEDUSA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No