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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine
• Intervention / Treatment: Behavioral: Smartphone based digital application

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • All India Institute of Medical Sciences, New Delhi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart phone based digital app arm; 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	Behavioral: Smartphone based digital application; Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog; Other Names: Paper pen diary
Active Comparator: Paper and pen diary arm; Clinic based education and traditional paper-pen diary will be administered in tracking headache parameters	Behavioral: Smartphone based digital application; Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog; Other Names: Paper pen diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIT-6 (Headache impact test-6) score	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.	4 weeks
Reduction in headache days	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 .	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	The proportion of patients who comply with using the digital smartphone based application vs paper-pen diary.	4 weeks
Number of headache days per 28 days	The number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary.	4 weeks
Change in number of headache days per 28 days from baseline	The change from baseline in number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary .	4 weeks
change from baseline in the number of days with severe headaches per 28 days	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.	4 weeks
Change from baseline in the duration of headache episodes in the preceding 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	4 weeks
Headache severity on VAS (Visual analogue scale)	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	4 weeks
Change from baseline in severity of headache on VAS scale (Visual analogue scale)	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	4 weeks
Number of headache episodes needing rescue medication	The number of headache episodes needing rescue medication in patients using the digital smartphone based application vs paper-pen diary.	4 weeks
Change from baseline in need for rescue medication	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.	4 weeks
Omission rates	Omission rates in daily diary entries in patients using the digital smartphone based application vs paper-pen diary.	4 weeks
Triggers	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.	4 weeks

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi

Study record dates

Study Major Dates

• Study Start (Anticipated): July 25, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Medication adherence; Mobile phone application; Behavioural intervention; Headache outcomes
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: IECPG-299/28.04.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: On reasonable request from the investigator through our AIIMS Institute ethics committee, the individual participant data will be made available to other researchers
• IPD Sharing Time Frame: will be available within 6 weeks for as long as suggested by our institute ethics committee
• IPD Sharing Access Criteria: Request to be made through the Institute ethics committee and would be processed as per Institute rules
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No