MigraineNCT04984720
Efficacy of Smartphone Based Digital Application in Improving Headache Related Parameters in Patients With Migraine
A study testing Smartphone based digital application in people with Migraine, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Smartphone based digital application
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jul 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, 110029
About this study
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
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Smartphone based digital application
- Keywords
- Mobile phone application, Behavioural intervention, Headache outcomes, Medication adherence, Quality of life
- Medical subject headings
- Migraine Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone based digital applicationBehavioural
Also called Paper pen diary
Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Smartphone based digital application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 4 weeks
Secondary outcomes (11)
Compliance
The proportion of patients who comply with using the digital smartphone based application vs paper-pen diary.
Measured: 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.
Measured: 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 diary .
Measured: 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 diary.
Measured: 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 diary
Measured: 4 weeks
Headache severity on VAS (Visual analogue scale)
Headache severity on VAS scale (0-10 with higher score meaning greater pain) in patients using the digital smartphone based application vs paper-pen diary
Measured: 4 weeks
Change from baseline in severity of headache on VAS scale (Visual analogue scale)
Change from baseline in severity of headache on VAS scale (0-10 with higher score meaning greater pain) in patients using the digital smartphone based application vs paper-pen diary
Measured: 4 weeks
Number of headache episodes needing rescue medication
The number of headache episodes needing rescue medication in patients using the digital smartphone based application vs paper-pen diary.
Measured: 4 weeks
Change from baseline in need for rescue medication
Change from baseline in number of headache episodes needing acute pain relief medications in patients using the digital smartphone based application vs paper-pen diary.
Measured: 4 weeks
Omission rates
Omission rates in daily diary entries in patients using the digital smartphone based application vs paper-pen diary.
Measured: 4 weeks
Triggers
Factors that trigger the onset of headaches (like specific foods, sleep deprivation, travel, etc) in patients using the digital smartphone based application vs paper-pen diary.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start25 Jul 2021
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arunmozhimaran Elavarasi, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984720
- Sponsor's protocol ID
- IECPG-299/28.04.2021
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On reasonable request from the investigator through our AIIMS Institute ethics committee, the individual participant data will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04984720
- Acronym / sponsor ID
- IECPG-299/28.04.2021
- Conditions
- Migraine
- Keywords
- Mobile phone application, Behavioural intervention, Headache outcomes, Medication adherence, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smart phone based digital app arm | Experimental | Behavioral: Smartphone based digital applicationDigital 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 |
| Paper and pen diary arm | Active comparator | Behavioral: Smartphone based digital applicationClinic based education and traditional paper-pen diary will be administered in tracking headache parameters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone based digital applicationAlso: Paper pen diarySmartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog | Behavioural | Paper and pen diary arm, Smart phone based digital app arm |
Primary outcome
Change in HIT-6 (Headache impact test-6) score
Time frame: 4 weeks
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.
Reduction in headache days
Time frame: 4 weeks
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 .
11 secondary outcomes
Compliance
Time frame: 4 weeks
Number of headache days per 28 days
Time frame: 4 weeks
Change in number of headache days per 28 days from baseline
Time frame: 4 weeks
change from baseline in the number of days with severe headaches per 28 days
Time frame: 4 weeks
Change from baseline in the duration of headache episodes in the preceding 4 weeks
Time frame: 4 weeks
Headache severity on VAS (Visual analogue scale)
Time frame: 4 weeks
Change from baseline in severity of headache on VAS scale (Visual analogue scale)
Time frame: 4 weeks
Number of headache episodes needing rescue medication
Time frame: 4 weeks
Change from baseline in need for rescue medication
Time frame: 4 weeks
Omission rates
Time frame: 4 weeks
Triggers
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. On reasonable request from the investigator through our AIIMS Institute ethics committee, the individual participant data will be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone based digital application in people with Migraine, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIT-6 (Headache impact test-6) score (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.