G43
Conditions
Interventions
Group 1: During study phase I (3 months), the intervention group receives treatment according to the new form of care (nVF).
Group 2: In study phase I, the control group continues to receive treatment
Sponsors
LMU Klinikum München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: At the time of inclusion (VE): 1. Adult patients (aged =18 years). 2. A diagnosis of migraine. 3. Statutory health insurance 4. Anamnestic: 4–25 headache days per month 5. Willingness to refrain from seeking specialist headache treatment from a neurological or pain therapy specialist during the study (except for the acute treatment of symptoms). 6. Sufficient knowledge of German to use the intended digital tools and educational videos. 7. Availability of a smartphone for use with the intended digital tools. 8. Consent to participate in the study after receiving written and verbal information. At the randomisation visit (VR): 9. Use of the DMKG app for at least 80% of the time during the 1-month baseline phase (daily entries in the headache calendar). If this criterion is not met, it is possible to repeat the 1-month baseline phase once. 10. Between four and 25 headache days during the one-month baseline phase.
Exclusion criteria
Exclusion criteria: At the inclusion visit (VE): 1. Start of drug-based headache prophylaxis within the last 3 months. 2. More than two failed migraine prophylactic treatments (amitriptyline, metoprolol, propranolol, flunarizine, topiramate, erenumab, fremanezumab, galcanezumab, eptinezumab, atogepant or rimegepant). 3. Previous participation in semi-inpatient/inpatient multimodal headache pain therapy. 4. Treatment at a participating centre/practice within the last 3 years. 5. Previous treatment within the DMKG headache registry (together with a participating physician, using the patient and physician portals). At the randomisation visit (VR): 6. Specialist treatment for headaches has been started in the meantime, unless this was necessary due to acute symptoms and did not extend beyond acute treatment. 7. Drug-based headache prophylaxis started in the meantime.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary endpoints are the change in headache days per month and headache-related impairment (measured using the Migraine Disability Assessment, MIDAS) after 3 months, comparing the new form of care with “treatment as usual.” | — |
Secondary
| Measure | Time frame |
|---|---|
| Several secondary endpoints have been defined, including a 12-month longitudinal evaluation using DASS (Depression Anxiety Stress Scales) and VR-12 (Veterans Rand-12) to assess health-related quality of life. In addition to evaluating headache-related endpoints, the study will also include a process evaluation (examining the use and usability of the digital portals) and a health economic evaluation. | — |
Countries
Germany
Contacts
Public ContactRuth Ruscheweyh
LMU Klinikum München
Outcome results
None listed