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NCT04984720Befejeződött

Efficacy of Smartphone Based Digital Application in Improving Headache Related Parameters in Patients With Migraine

Efficacy of Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders and Community Blog in Improving Headache Related Parameters as Compared to Paper Pen Diary in Patients With Migraine - Cross Over RCT

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 7.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Migraine is a common headache disorder and affects 1 in 5 adults during their lifetime. It is a disorder which leads to significantly impaired quality of life, absence from work, loss of productivity in workplace and reduced vitality in social functioning. One of the important cornerstones in the management of migraine is the maintenance of a good headache diary. A headache diary enables the physician to understand the headache characteristics as well to establish the triggers causing the precipitation of episodes. The other important measure to ensure good outcomes is compliance to medications in those who have been prescribed prophylaxis. Migraine prophylaxis is by pills that have to be taken everyday at fixed time to ensure best outcomes. However, it is known that patients with migraine often are not adherent to prophylactic medications. A meta-analysis of 33 studies found that observational studies (n = 14) showed adherence ranging from 41% to 95% at 2 months after initiation of medication and 21% to 80% at 6 months. Pooled rates of persistence derived from 19 RCTs on propranolol, amitriptyline, and topiramate showed adherence rates of 77%, 55%, and 57%, respectively, at 16-26 weeks of initiation. The real world adherence is expected to be lower than that in the ideal settings of randomized trials. Regular pill reminders issued through smartphone based applications can improve medication adherence and thus improve headache outcomes. Though smartphone based migraine tracker digital applications are available, they mostly are aimed at capturing headache characteristics. The efficacy of providing pill reminders along with patient educational materials and community blog to enable migraineurs share their experiences with each other has not been studied in controlled trials. It is known that patients who are well informed about their chronic diseases such as migraine often have better outcomes. Busy clinicians often resort to providing pamphlets regarding the disease, triggers, acute pain relief medications, prophylactic therapy etc. However, it is yet to be studied if a digital application with all these inbuilt features, which are easily accessible at the finger tips would lead to better information uptake and improved compliance and self management. This RCT would try to assess this gap in knowledge.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
403 (tényleges)
Első benyújtás
2021. júl. 18.
Kezdés
2021. júl. 25.
Elsődleges befejezés
2025. aug. 31.
Fő szponzor
All India Institute of Medical Sciences
Betegségek
Migrén
NCT-szám
NCT04984720

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 403
  • 2021. júl. 25. és az elsődleges befejezés (2025. aug. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Patients with Medication over use headache ( as per ICHD -3).

Más betegség

  • Other primary headaches and secondary headache disorders.

Egyéb

  • Not willing to adhere to protocol.
  • Not willing to provide consent.
  • Inability or unwillingness to complete diary recording.

Kiket keres a vizsgálat

  • Adult patients attending neurology OPD.
  • At least 18 years of age; any gender.
  • Episodic or chronic migraine diagnosed (using International Classification of Headache Disorders-3 (ICHD-3) .
  • No modifications to the prophylactic therapy or acute pain relief medications is planned over the next 3 months.
  • Can read and write in Hindi or English easily.
  • Have an Android/iOS smart phone in which digital application can be installed and who knows how to operate smart phone.
  • Ready to provide consent and willing to adhere to protocol and comply with follow up visits.
  • No major neurological or systemic medical condition that reduces life expectancy to less than 1 year based on clinical prediction scores.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
All India Institute of Medical Sciences, New DelhiNew DelhiIndiaIsmeretlen állapot

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