G43
Conditions
Interventions
Group 1: "SMARTGEM - Intervention" consisting of "M-sense Premium", online consultation, patient forum and teleconsulatation for 6 months (optional extension to 12 months)
Group 2: "SMARTGEM - Control
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - First presentation in the headache outpatient department of the Charité Universitätsmedizn Berlin, Universitätsmedizin Rostock or Universitätsklinik Halle - Diagnosis of episodic migraine with at least 5 migraine days / month or chronic migraine with or without aura according to the IHCD-3 criteria - onset of migraine before the age of 50 and lasting for at least a year - Own an Android or iOS enabled smartphone with mobile internet access and basic understanding of apps - Ability and readiness to give a written informed consent - Insured with a statutory health insurance - The M-sense calendar has been completed with a compliance rate of at least 80% in the last 28 days prior to inclusion - The subject documented at least 5 migraine days in the baseline phase with M-sense over a period of 28 days
Exclusion criteria
Exclusion criteria: • Previous use of the M-sense active app more than 14 days • Diagnosis of another headache disease besides migraine (all secondary headaches and primary headaches of the ICHD-3 group 3 and 4) Tension-type headaches (ICHD-3 group 2) are allowed, provided they do not account for more than 50% of headache days / month • Previous or current drug or alcohol abuse within one year prior to visit (excessive or compulsory use as determined by the study physician) • Current use of medication that indicates evidence of abuse or dependency (exception: analgesic or triptan overuse) • Taking more than 3 doses / month of opioids or barbiturates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of migraine days per 28 days in month 6 after enrollment compared to baseline (day -28 until day 0) and between patients in intervention group and control group | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of patients with at least 50% reduction in migraine days / month in month 6 compared to baseline and between patients in the intervention group and patients in the control group • Reduction of the headache days / month in month 6 compared to baseline and between patients in the intervention group and patients in the control group • Improvement in migraine-related limitations (change in scores from baseline at month 6 in the self-assessment questionnaire: HIT-6) and between patients in the intervention group and patients in the control group • Improvement of the state of health (change of the point values ??from the starting value at month 6 in the questionnaire for self-assessment: EQ-5D-5L) and between patients in the intervention group and patients in the control group • Change in the days of taking headache medication at month 6 compared to baseline and between patients in the intervention group and patients in the control group • Improvement in quality of life (change in scores from baseline at month 6 in the self-assessment questionnaire: PROMIS 29) and between patients in the intervention group and patients in the control group • Reduction of the total illness costs in the 6-month observation period and between patients in the intervention group and patients in the control group • Reduction of the days with incapacity to work in the 6 month period | — |
Countries
Germany
Contacts
Public ContactLars Neeb
Klinik und Hochschulambulanz für NeurologieCharité Universitaetsmedizin Berlin
Outcome results
None listed