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

Migraine Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04984720
• Other study ID #: IECPG-299/28.04.2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2021
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Arunmozhimaran Elavarasi, MD DM
• Phone: +919013844274
• Email: arun_ela[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Smartphone based digital application
Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences, New Delhi	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Compliance	The proportion of patients who comply with using the digital smartphone based application vs paper-pen diary.	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Omission rates	Omission rates in daily diary entries in patients using the digital smartphone based application vs paper-pen diary.	4 weeks
Secondary	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