Smartphone Based Digital Application v/s Paper Pen Diary in Patients With Migraine

Efficacy Of Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog for Migraineurs in Improving Headache Related Parameters as Compared to Paper Pen Diary in Patients With Migraine –A Randomized Controlled Cross Over Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060310

Enrollment

400

Registered

2023-11-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G439- Migraine, unspecified

Interventions

Intervention1: Digital application: An application on mobile phone to track migraine, offer pill reminders for medication adherence and community blogs Duration of intervention - 4 weeks Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: a. Adult patients attending neurology OPD b. At least 18 years of age; any gender c. Episodic or chronic migraine diagnosed (using International Classification of Headache Disorders-3 (ICHD-3) d. No modifications to the prophylactic therapy or acute pain relief medications is planned over the next 3 months e. Can read and write in Hindi or English easily f. Have an Android/iOS smart phone in which digital application can be installed and who knows how to operate smart phone. g. Ready to provide consent and willing to adhere to protocol and comply with follow up visits h. No major neurologic or systemic medical condition that reduces life expectancy to less thanone year based on clinical prediction scores

Exclusion criteria

Exclusion criteria: a. Not willing to provide consent. b. Not willing to adhere to protocol c. Inability or unwillingness to complete diary recording d. Patients with medication over use headache ( as per ICHD -3) e. Other primary headaches and secondary headache disorders

Design outcomes

Primary

Measure	Time frame
1. To compare the change in HIT-6 (Headache impact test-6) score from baseline to 4 weeks after introduction of the digital smartphone based application vs paper-pen diary 2. 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 diaryTimepoint: 4 months	—

Secondary

Measure	Time frame
1. The proportion of patients who comply with using the digital smartphone based application vs paper-pen diary. 2. The number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary. 3. The change from baseline in number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary . 4. 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. 5. 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. 6. Headache severity on VAS scale in patients using the digital smartphone based application vs paper-pen diary. Timepoint: 4 months	—

Measure

Time frame

1. The proportion of patients who comply with using the digital smartphone based application vs paper-pen diary. 2. The number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary. 3. The change from baseline in number of headache days per 28 days following usage of digital smartphone based application vs paper-pen diary . 4. 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. 5. 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. 6. Headache severity on VAS scale in patients using the digital smartphone based application vs paper-pen diary. Timepoint: 4 months

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Countries

India

Contacts

Public ContactArchita Makharia

AIIMS New Delhi

arun_ela@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026