G43
Conditions
Interventions
Group 1: M-Sense Migraine is used by patients during the study. The app includes, among other things, a comprehensive mobile diary for tracking headache days, medication use, and trigger factors, as w
Sponsors
Newsenselab GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary outcomes based on the diary within the app: • Migraine days per month (months defined as 28 days) week 1 to 4 and week 5 to 8. • Headache days per month (months defined as 28 days) week 1 to 4, week 5 to 8, and week 9 to 12. The headache days are defined as the number of days on which headaches have been documented by the patient in the diary. The number of headache days per month is then obtained by adding up the number of days on which headaches have been reported. • Moderate/severe headache days (defined as a headache that is longer than 4 hours and is accompanied with a pain severity of at least 4, as reported on the in-app 11-point numeric rating scale (NRS) for pain, 0=”kein Schmerz” to 10=”stärkster Schmerz”) per months (defined as 28 days) after 12 weeks (week 9 to 12). Furthermore, we will analyze week 1 to 4 and week 5 to 8. • Treatment responder defined as at least a 30% reduction in migraine days per month (defined as 28 days) after 12 weeks (week 9 to 12) compared to baseline. Study dropouts will be handled as non-responders in the analysis. • Drug consumption for acute pain treatment includes: a) days with medication for acute pain, and b) days with triptane use. This is documented in the daily medication diary (week 1- 12). Secondary outcomes based on questionnaires within the app: • Migraine specific quality of life measured with the 6-item Headache Impact Text (HIT-6) over the last 4 weeks after 12 weeks. • Self-efficacy measured with the 6-item short form of the German language adapted headache management self-efficacy scale (HMSE-G-SF) over the last 4 weeks measured after 12 weeks. within four consecutive weeks (28 days). • Headache attributed burden such as disability and headache attributed lost time is measured with the 5-item Headache-Attributed Lost Time indices (HALT-30 , official German translated Version) over the last 30 days after 12 weeks. • Migraine-specific health literacy after 12 weeks (3 items, own develop | — |
Countries
Germany
Contacts
Public ContactDaniel Pach
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité – Universitätsmedizin Berlin
Outcome results
None listed