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

NCT05979285 | Completed

• 1 other identifier: MEDUSA1
• Study Type: interventional
• Target: 887
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Self-Assessment

Keywords

migraine; patient diary

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• previous use of digital diary Apps for migraine

  30 days

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

  90 days

• Health Confidence and digital diary App

  90 days

Study Arms (1)

N1-Headache App

EXPERIMENTAL

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

N1-Headache App (by Curelator) DEVICE

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

N1-Headache App

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumbria Partnership NHS Foundation Trust: lead

Study Sites (1)

Research & Development Department

Carlisle, Cumbria, CA1 3SX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35364371 RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stacey J Fisher, MD

  substantive employee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 7, 2023
• Study Start: October 15, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 20, 2021
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)