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

NCT ID: NCT04984720

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-25

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Migraine

Keywords

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Mobile phone application Behavioural intervention Headache outcomes Medication adherence Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

* 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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The participant, investigator and care provider will be aware of the intervention and the sequence in which it is administered.

The outcomes will be assessed by an outcome assessor who will not be aware of the arm into which the participant was randomized prior to the assessment.

Study Groups

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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

Group Type EXPERIMENTAL

Smartphone based digital application

Intervention Type BEHAVIORAL

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

Paper and pen diary arm

Clinic based education and traditional paper-pen diary will be administered in tracking headache parameters

Group Type ACTIVE_COMPARATOR

Smartphone based digital application

Intervention Type BEHAVIORAL

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

Interventions

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Smartphone based digital application

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Paper pen diary

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Arunmozhimaran Elavarasi

Assistant Professor, Department of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Central Contacts

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Arunmozhimaran Elavarasi, MD DM

Role: CONTACT

Phone: +919013844274

Email: [email protected]

Padma Srivastava MV, MD DM

Role: CONTACT

Phone: +919868398261

Email: [email protected]

Facility Contacts

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Arunmozhimaran Elavarasi, MD DM

Role: primary

Padma Srivastava MV, MD DM

Role: backup

Other Identifiers

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IECPG-299/28.04.2021

Identifier Type: -

Identifier Source: org_study_id