Health Condition 1: G43- Migraine
Conditions
Interventions
Intervention1: Smart phone based digital application for 4 weeks: Digital smartphone application to track migraine and
to offer pill reminders for medication adherence and
community blog and disease r
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients attending neurology OPD. At least 18 years of age; any gender. 2. Episodic or chronic migraine diagnosed (using International Classification of Headache Disorders-3 (ICHD-3) . 3. No modifications to the prophylactic therapy or acute pain relief medications is planned over the next 3 months. 4. Can read and write in Hindi or English easily. 5. Have an Android/iOS smart phone in which digital application can be installed and who knows how to operate smart phone. 6. Ready to provide consent and willing to adhere to protocol and comply with follow up visits. 7. No major neurological or systemic medical condition that reduces life expectancy to less than 1 year based on clinical prediction scores
Exclusion criteria
Exclusion criteria: 1. Not willing to adhere to protocol. 2. Not willing to provide consent. 3. Inability or unwillingness to complete diary recording. 4. Patients with Medication over use headache ( as per ICHD -3). 5. Other primary headaches and secondary headache disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HIT-6 (Headache impact test-6) score 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.Timepoint: Change in HIT-6 (Headache impact test-6) score 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in need for rescue medication Change from baseline in need for rescue medication in patients using the digital smartphone based application vs paper-pen diary.Timepoint: 4 weeks;Change from baseline in severity of headache on VAS scale Change from baseline in severity of headache on VAS scale in patients using the digital smartphone based application vs paper-pen diaryTimepoint: 4 weeks;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 diaryTimepoint: 4 weeks;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 diaryTimepoint: 4 weeks;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 diaryTimepoint: 4 weeks;Co primary outcome: 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 diaryTimepoint: 4 weeks;Compliance The proportion of patients who comply with using the digital smartphone based application vs paper-pen diary. Timepoint: 4 weeks;Headache severity on VAS Headache severity on VAS scale in patients using the digital smartphone based application vs paper-pen diaryTimepoint: 4 weeks;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.Timepoint: 4 weeks;Number of headache episodes needing rescue medication The nu | — |
Countries
India
Contacts
Public ContactRahul Chawla
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed