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

A

All India Institute Of Medical Science (AIIMS)

Status

Unknown

Conditions

Migraine

Treatments

Behavioral: Smartphone based digital application

Study type

Interventional

Funder types

Other

Identifiers

NCT04984720
IECPG-299/28.04.2021

Details and patient eligibility

About

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.

Full description

Migraine is a common headache disorder which leads to significantly impaired quality of life, absence from work, loss of productivity in workplace and reduced vitality in social functioning. A structured migraine diary can be a valuable aid for improving communication between patients and physicians regarding migraine disability and treatment outcomes. The other possible measure to ensure improved outcome in migraine patients is better adherence to prophylactic treatment of migraine. Migraine prophylaxis is by pills that have to be taken every day at fixed time to ensure best outcomes. However, it is known that patients with migraine often are not adherent to prophylactic medications. Regular pill reminders issued through smartphone based applications may help improve medication adherence and hence, 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • Not willing to adhere to protocol.
  • Not willing to provide consent.
  • Inability or unwillingness to complete diary recording.
  • Patients with Medication over use headache ( as per ICHD -3).
  • Other primary headaches and secondary headache disorders.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

400 participants in 2 patient groups

Smart phone based digital app arm
Experimental group
Description:
Digital smartphone application which tracks migraine and to offers pill reminders for medication adherence and community blog and disease related educational material for migraineurs will be given to the patients
Treatment:
Behavioral: Smartphone based digital application
Paper and pen diary arm
Active Comparator group
Description:
Clinic based education and traditional paper-pen diary will be administered in tracking headache parameters
Treatment:
Behavioral: Smartphone based digital application

Trial contacts and locations

1

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Central trial contact

Padma Srivastava MV, MD DM; Arunmozhimaran Elavarasi, MD DM

Data sourced from clinicaltrials.gov

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