Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Rate of perfect adherence
研究概览
简要总结
People with multiple sclerosis (MS) have variable adherence to MS medications, making the full efficacy of disease modifying therapies unrealized and the assessment of true treatment failures challenging. Whereas some patients forget to take medications due to active lifestyles, others may have cognitive impairments that prevent them from organizing and planning their regular dosing schedules. An electronic pill cap ("Pillsy") has been developed to record pill taking, timing, and set reminders through a mobile app. Data on adherence can be captured and analyzed remotely for health care provider review.
详细描述
The investigators will enroll 85 adult patients, 18 years old and above, with relapsing remitting multiple sclerosis (RRMS), at the Massachusetts General Hospital MS Clinics in a pilot study of Pillsy electronic pill bottles. People with RRMS who are taking (1) fingolimod, (2) dimethyl fumarate, (3) terifluonomide, (4) diroximel fumarate, or (5) siponimod will be eligible. Patients must possess any type of smartphone capable of downloading the Pillsy application to be eligible. Per the Pillsy manufacturer, the Pillsy application is available on iPhones connected to the Apple App Store and smartphones running the Android operating system that are connected to the Google Play Store. Participants will be asked to use the Pillsy bottle for 90 days each. Participants will be randomized 1:1 to two conditions: 1) active reminders and 2) passive adherence tracking. Patients in the active reminders group will receive daily alerts through the Pillsy bottle, the Pillsy app, and their phone to remind them to take their pill. Patients in the passive adherence tracking group will not receive reminders and will instead have usual adherence monitored by the electronic pill bottle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Ability to provide individual written consent
- •Ability to understand sufficient levels of English to use the Pillsy app
- •Ability to come to Massachusetts General Hospital for two study visits over a 90-day window OR ability to access Zoom for virtual study visits
- •Possess a smartphone
- •Willingness to follow the study protocol
排除标准
- •Presence of an MS relapse requiring acute management and/or hospitalization
- •Daily medication provided by allied health care workers
- •Foreign travel preventing electronic remote monitoring
- •Expectation of discontinuation of the oral disease modifying therapy (DMT) in the upcoming 90 days for any reason
结局指标
主要结局
Rate of perfect adherence
时间窗: 90-days post-enrollment
Perfect adherence is defined as taking all scheduled pills +/-3 hours of scheduled dosing time
次要结局
- Participant satisfaction(90-days post-enrollment)
研究者
Farrah Mateen
Associate Professor of Neurology
Massachusetts General Hospital