Clinical trial NCT04984720: Efficacy of Smartphone Based Digital Application in Improving Headache Related Parameters in Patients With Migraine
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Keywords: Mobile phone application
Behavioural intervention
Headache outcomes
Medication adherence
Quality of life
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: * A run-in period of 4 weeks prior to randomization to optimize therapy and to document the baseline frequency and severity of headaches.
* At the end of run-in period, the patients will be randomly allocated into the smartphone based digital App first arm or the paper diary first arm. The digital app and paper diary- are available in Hindi as well as English.
* Randomization will be done by computer generated random number table.
* Concealment: The sequence of allocation will be held concealed by opaque sealed envelopes.
* Participant and investigator both will be aware of the allocated group - it is an open label study.
* Participants will be followed up at 4 weeks and the headache characteristics and outcome parameters would be captured from the app and paper diary respectively.
* Subsequently patients would be crossed over to the other arm and 4 weeks after the cross over, parameters would again be assessed.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HIT-6 (Headache impact test-6) score
timeFrame: 4 weeks
measure: Reduction in headache days
timeFrame: 4 weeks
Secondary outcomes:
measure: Compliance
timeFrame: 4 weeks
measure: Number of headache days per 28 days
timeFrame: 4 weeks
measure: Change in number of headache days per 28 days from baseline
timeFrame: 4 weeks
measure: change from baseline in the number of days with severe headaches per 28 days
timeFrame: 4 weeks
measure: Change from baseline in the duration of headache episodes in the preceding 4 weeks
timeFrame: 4 weeks
measure: Headache severity on VAS (Visual analogue scale)
timeFrame: 4 weeks
measure: Change from baseline in severity of headache on VAS scale (Visual analogue scale)
timeFrame: 4 weeks
measure: Number of headache episodes needing rescue medication
timeFrame: 4 weeks
measure: Change from baseline in need for rescue medication
timeFrame: 4 weeks
measure: Omission rates
timeFrame: 4 weeks
measure: Triggers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences, New Delhi
state: Delhi
Study officials:
References: