Skip to main content
OpenTrials
Completed

NCT Number: NCT04984720

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone based digital application

Behavioral

Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog

Other names: Paper pen diary

Primary outcomes

  1. Change in HIT-6 (Headache impact test-6) score

    Time frame: 4 weeks

    To compare the change in HIT-6 (Headache impact test-6 ranges from 36-78 with a higher score indicating greater severity) score from baseline to 4 weeks after introduction of the digital smartphone based application vs paper-pen diary.

  2. Reduction in headache days

    Time frame: 4 weeks

    To compare the percentage of patients reporting 30 % or more reduction in headache days at 4 weeks following introduction of digital smart phone based application vs paper-pen diary .

Secondary outcomes

  1. Compliance

    Time frame: 4 weeks

    The proportion of patients who comply with using the digital smartphone based application vs paper-pen diary.

  2. Number of headache days per 28 days

    Time frame: 4 weeks

    The number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary.

  3. Change in number of headache days per 28 days from baseline

    Time frame: 4 weeks

    The change from baseline in number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary .

  4. change from baseline in the number of days with severe headaches per 28 days

    Time frame: 4 weeks

    The change from baseline in the number of days with severe headaches in the preceding 4 weeks as compared with baseline in patients using the digital smartphone based application vs paper-pen diary.

  5. Change from baseline in the duration of headache episodes in the preceding 4 weeks

    Time frame: 4 weeks

    The change from baseline in the duration of headache episodes in the preceding 4 weeks as compared with baseline in patients using the digital smartphone based application vs paper-pen diary

  6. Headache severity on VAS (Visual analogue scale)

    Time frame: 4 weeks

    Headache severity on VAS scale (0-10 with higher score meaning greater pain) in patients using the digital smartphone based application vs paper-pen diary

  7. Change from baseline in severity of headache on VAS scale (Visual analogue scale)

    Time frame: 4 weeks

    Change from baseline in severity of headache on VAS scale (0-10 with higher score meaning greater pain) in patients using the digital smartphone based application vs paper-pen diary

  8. Number of headache episodes needing rescue medication

    Time frame: 4 weeks

    The number of headache episodes needing rescue medication in patients using the digital smartphone based application vs paper-pen diary.

  9. Change from baseline in need for rescue medication

    Time frame: 4 weeks

    Change from baseline in number of headache episodes needing acute pain relief medications in patients using the digital smartphone based application vs paper-pen diary.

  10. Omission rates

    Time frame: 4 weeks

    Omission rates in daily diary entries in patients using the digital smartphone based application vs paper-pen diary.

  11. Triggers

    Time frame: 4 weeks

    Factors that trigger the onset of headaches (like specific foods, sleep deprivation, travel, etc) in patients using the digital smartphone based application vs paper-pen diary.

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2021
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.