MigraineMEDUSANCT05979285
MEDUSA Study - Migraine: Evaluation of Diagnosis, Utilisation of Services and Application
A study testing N1-Headache App (by Curelator) in people with Migraine and Self-Assessment, run by Cumbria Partnership NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Migraine, Self-Assessment
- What is being tested?
- N1-Headache App (by Curelator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 887 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2020to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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)
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research & Development Department
Carlisle, Cumbria, CA1 3SX
About this study
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
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.
- Conditions
- Migraine, Self-Assessment
- Being tested
- N1-Headache App (by Curelator)
- Keywords
- migraine, patient diary
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1-Headache App (by Curelator)Device
Digital application allowing patients to monitor their migraines, and to identify triggers and/or protectors for their migraines.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: N1-Headache App (by Curelator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient interest in N1 Headache App
percentage of survey responders who indicate they are willing to trial the N1 Headache App
Measured: 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
Measured: 90 days
Secondary outcomes (3)
previous use of digital diary Apps for migraine
what percentage of responders has previously used a digital diary App for migraine
Measured: 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
Measured: 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'
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start15 Oct 2020
- Primary completion31 Jul 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumbria Partnership NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey J Fisher, MD, Principal investigator, substantive employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979285
- Sponsor's protocol ID
- MEDUSA1
- Acronym
- MEDUSA
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05979285
- Acronym / sponsor ID
- MEDUSA / MEDUSA1
- Conditions
- Migraine, Self-Assessment
- Keywords
- migraine, patient diary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 887 participants (actual)
- Lead sponsor
- Cumbria Partnership NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| N1-Headache App | Experimental | Device: N1-Headache App (by Curelator)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) |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- • 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.
Key exclusion criteria (3 listed)
- • Under the age of 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N1-Headache App (by Curelator)Digital application allowing patients to monitor their migraines, and to identify triggers and/or protectors for their migraines. | Device | N1-Headache App |
Primary outcome
patient interest in N1 Headache App
Time frame: 30 days
percentage of survey responders who indicate they are willing to trial the N1 Headache App
user compliance for N1 Headache App
Time frame: 90 days
percentage of participants who consent to using the App who comply with daily use in 90 day trial period
3 secondary outcomes
previous use of digital diary Apps for migraine
Time frame: 30 days
usefulness of N1 Headache App: percentage patients who identify a migraine trigger
Time frame: 90 days
Health Confidence and digital diary App
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Results publication: PubMed 35364371Jonker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey J Fisher, MD principal investigator
substantive employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N1-Headache App (by Curelator) in people with Migraine and Self-Assessment, run by Cumbria Partnership NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient interest in N1 Headache App (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05979285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.