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Smarthpone gestützte Migränetherapie



Short title: SMARTGEM

Investigated disease: Migräne

Principal Investigator: Dr. med. Lars Neeb


Clinic, Institute: Klinik für Neurologie mit Experimenteller Neurologie CBF

Proband (healthy)
Age: 18 - 99
Gender: All
Last change: 23.09.2021

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Study Description

Title

Smarthpone gestützte Migränetherapie

Short title

SMARTGEM

General Short Description

With the project SMARTGEM we want to investigate the efficacy of a new healthcare mode in migraine therapy. SMARTGEM consists of a smartphone app (M-sense) in conjunction with digital offerings to shorten the communication between patients, university headache outpatient department and resident doctors in private practice. For patients with frequent migraine (≥ 5 migraine days per month)we want to achieve a reduction of migraine attacks and the intake of acute headache medication. Our goal is to improve the quality of life of migraine sufferers and to prevent headache chronification. The efficacy of SMARTGEM will be assessed in a randomized controlled trial. Patients with frequent migraine from Berlin, Brandenburg, Mecklenburg-Vorpommern and Saxony-Anhalt, who suffer from at least 5 migraine days / month can participate in the study.

Scientific Short Description

New options in the outpatient care of headache patients include smartphone-based programs ("apps"). In addition to a documentary function as a headache ediary, they can also contribute to an improved understanding of the headache disorder through education. They may guide cognitive-behavioral-therapeutic exercises based on electronic methods. However, the majority of commercially available headache apps are not evaluated and/or their content is not evidence-based. The efficacy of smartphone-based apps of cognitive behavioral therapy under medical guidance has not been evaluated in headache and migraine therapy.
The new model of healthcare SMARTGEM aims to complement existing multimodal therapy in freuqent migraine ( ≥ 5 migraine days / month) using digital supported and location independent services:
a) Headache documentation and identification of trigger factors, provision of a modular non-medication preventive therapy offer by introducing a smartphone app (M-sense Premium)
b) patient forum (moderated by a physician) and "online consultation" via 1:1 chat
c) Telemedicine network and teleconsultation between university headache outpatient department and resident doctors for location independent case conferences
Efficacy of SMARTGEM will be evaluated in a randomized controlled trial with the primary endpoint reduction of migraine days / month after 6 observational months (week 20 - 24) in comparison to baseline (week -4 until week 0). Patients who use the app M-sense for pure headache documentation without trigger analysis and therapy module (M-sense basis) without access to further online services (forum, online-consultation, tele-consultation) will serve as control group.

WebsitePrimary Register Type

DRKS-No.

Primary Register-ID

DRKS00016328

Study start

01.01.2019

Study end

30.10.2021

Investigated Disease, Health Issue

ICD-Code
  • G43 - Migräne

Inclusion Criteria

Age

18 - 99

Gender

All

Additional 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

  • 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

Characteristics

Studytype

Interventional

Studyphase

2-3

Primary Outcome

Reduktion der Migränetage/pro 28 Tage im Monat 6 (nach Erstvorstellung in der
Kopfschmerzambulanz (Regelversorgung) im Vergleich zum Ausgangswert (Tag -28 bis Tag 0)
und zwischen Patienten in der Interventionsgruppe und Patienten in der Kontrollgruppe

Secondary Outcome

Anzahl der Patienten mit mindestens 50% Reduktion der Migränetage/Monat im Monat 6 im
Vergleich zum Ausgangswert im Vergleich zwischen Patienten in der Interventionsgruppe und
Patienten in der Kontrollgruppe
• Reduktion der Kopfschmerztage/Monat im Monat 6 im Vergleich zum Ausgangswert im
Vergleich zwischen Patienten in der Interventionsgruppe und Patienten in der Kontrollgruppe
Verbesserung der Migräne bezogenen Einschränkung (Änderung der Punktwerte vom Ausgangswert zu Monat 6 in den Fragebogen zur Selbsteinschätzung: HIT-6) und zwischen Patienten in der Interventionsgruppe und Patienten in der Kontrollgruppe
• Verbesserung des Gesundheitszustandes (Änderung der Punktwerte vom Ausgangswert zu Monat 6 in den Fragebogen zur Selbsteinschätzung: EQ-5D-5L) und zwischen Patienten in der Interventionsgruppe und Patienten in der Kontrollgruppe
• Änderung der Einnahmetage von Kopfschmerzmedikation im Monat 6 im Vergleich zum Ausgangswert und zwischen Patienten in der Interventionsgruppe und Patienten in der Kontrollgruppe
• Verbesserung der Lebensqualität (Änderung der Punktwerte vom Ausgangswert zu Monat 6 in den Fragebogen zur Selbsteinschätzung: PROMIS 29) und zwischen Patienten in der Interventionsgruppe und Patienten in der Kontrollgruppe
• Reduktion der Gesamtkrankheitskosten im 6-Monats-Beobachtungszeitraum und zwischen Patienten in der Interventionsgruppe und Patienten in der Kontrollgruppe
• Reduktion der AU-Tage im 6 Monats Zeitraum

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