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

NCT04984720 | Unknown

• 1 other identifier: IECPG-299/28.04.2021
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Compliance

  4 weeks

• Number of headache days per 28 days

  4 weeks

• Change in number of headache days per 28 days from baseline

  4 weeks

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

  4 weeks

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

  4 weeks

Study Arms (2)

Smart phone based digital app arm

EXPERIMENTAL

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

Paper and pen diary arm

ACTIVE COMPARATOR

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

Behavioral: Smartphone based digital application

Interventions

Smartphone based digital application BEHAVIORAL

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

Also known as: Paper pen diary

Paper and pen diary arm; Smart phone based digital app arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences, New Delhi

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

Location

MeSH Terms

Conditions

Migraine Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Arunmozhimaran Elavarasi, MD DM

CONTACT

+919013844274; arun_ela@yahoo.com

Padma Srivastava MV, MD DM

CONTACT

+919868398261; vasanthapadma123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurology

Model Details: * 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.

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 30, 2021
• Study Start: July 25, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: will be available within 6 weeks for as long as suggested by our institute ethics committee
• Access Criteria: Request to be made through the Institute ethics committee and would be processed as per Institute rules

Locations

IN (1)