G43 G44.4 F55.2
Conditions
Interventions
Group 1: The control group will receive unspecific messages providing information on general trigger factors or latest migraine research highlights.
Group 2: The intervention group will receive the sa
Sponsors
Universitätsklinikum Essen in Wahrnehmung der Aufgaben der Universität Duisburg-Essen, Campus Essen, Fachbereich Medizin; Institution: Institut für Medizinische Informatik, Biometrie und Epidemiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Migraine patients: Patients with frequent episodic migraine (EM) (= 8-14 headache days/month, of which 4 fulfill IHS criteria for migraine) or chronic migraine (CM) (=15 headache days/month, of which 8 fulfill IHS criteria for migraine) OR Post-MO(H)-Patients: Patients, who underwent treatment for MO(H) (initially = 15 headache days/month, intake of attack aborting medication on 10 or more or 15 or more days/month according to International Classification of Headache Disorders (ICHD-3) criteria of mediation overuse headache (MOH)) AND 2) Owning a mobile device with iOS or Android system, which is able to run the App 3) Adults = 18 years 4) Written informed consent consistent with ICH-GCP (International Conference of Harmonization – Good Clinical Practice) guidelines and local laws signed prior to all study-related procedures 5) Compliance for using the App on = 80% days during the screening period
Exclusion criteria
Exclusion criteria: 1) Patients with concomitant primary headache disorders, other than EM or CM (except tension-type headache 3 days/month 5) Regular intake (> 15 days/month) of (i) hypnotics, (ii) benzodiazepines as sedatives (tranquillizer), (iii) antipsychotics (neuroleptics) in psychiatric indication 6) Parallel use of other migraine apps to track headache days and medication intake
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients developing MO or MOH according to ICHD-3 for at least 3 consecutive months between baseline and end of study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Migraine specific disability assessment (MIDAS) score; Number of headache days/month; Number of days with attack aborting medication per month; Psychiatric comorbidity by means of the Depression Anxiety Stress Scale (DASS) score; Severity of headaches; Time to MO or MOH; For patients, who have reached the primary endpoint during the study: Number of headache days/month and number of days with attack aborting therapy per month in the last study month; Frequency of serious adverse events (SAEs) | — |
Countries
Germany
Outcome results
None listed