Effectiveness of the M-sense Migräne app – a randomized controlled study - EMMA Study
- Conditions
- G43Migraine
- Registration Number
- DRKS00024174
- Lead Sponsor
- ewsenselab GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 476
Adults = 18 years with migraine (ICD-10 G43) diagnosed by a physician,
-Disease duration of at least 1 year (patient reported),
-At least 3 migraine days in the previous 28 days,
-Disease onset before age 50 years,
-Migraine screening questions positively answered,
-Smartphone ownership and smartphone literacy,
-Sufficient knowledge of German,
-Informed consent
-Planned pregnancy, pregnant and breastfeeding women (hormone status has an impact on the headache and migraine days),
-Medication overuse headache (assessed by physician question, app data during baseline > 15 days with medication),
-Headache app / M-sense or similar app use of at least a month during the last 12 months,
-Planned start of a new treatment for migraine within the next 4 months,
-Simultaneous participation in another interventional study,
-Users who have filled in the diary <3 days/week during baseline
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Migraine days per month (defined as 28 days) after 12 weeks (in weeks 9-12), collected via the diary included in the routine version of the app.
- Secondary Outcome Measures
Name Time Method