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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 2
- 主要终点
- Change in HIT-6 (Headache impact test-6) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Smartphone based digital application (Behavioral)
Paper and pen diary arm
Clinic based education and traditional paper-pen diary will be administered in tracking headache parameters
干预措施: Smartphone based digital application (Behavioral)
结局指标
主要结局
Change in HIT-6 (Headache impact test-6) score
时间窗: 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
时间窗: 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 .
次要结局
- Headache severity on VAS (Visual analogue scale)(4 weeks)
- Change from baseline in need for rescue medication(4 weeks)
- Omission rates(4 weeks)
- Compliance(4 weeks)
- Number of headache days per 28 days(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)
- Change from baseline in severity of headache on VAS scale (Visual analogue scale)(4 weeks)
- Number of headache episodes needing rescue medication(4 weeks)
- Change in number of headache days per 28 days from baseline(4 weeks)
- Triggers(4 weeks)
研究者
Arunmozhimaran Elavarasi
Assistant Professor, Department of Neurology
All India Institute of Medical Sciences