Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Electronic Pill Bottle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 1:1 trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Reminders<br>43 patients, each assigned to use the electronic pill bottle for 90 days. Participants will use the bottle to house their multiple sclerosis medication. The electronic pill bottle will provide daily medication reminders for participants to take their pill. | Device: Electronic Pill Bottle<br>* Electronic bottles that can beep and blink to send medication use reminders, record medication use data, and upload medication use data to a secure server.<br>* Other names: Pillsy;|
| Experimental: Passive Adherence Monitoring<br>42 patients, each assigned to use the electronic pill bottle for 90 days. Participants will use the bottle to house their multiple sclerosis medication. The electronic pill bottle will not provide medication reminders and will only track medication use. | Device: Electronic Pill Bottle<br>* Electronic bottles that can beep and blink to send medication use reminders, record medication use data, and upload medication use data to a secure server.<br>* Other names: Pillsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perfect adherence | Perfect adherence is defined as taking all scheduled pills +/-3 hours of scheduled dosing time | 90-days post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction | Participant satisfaction with the use of an electronic pill bottle and app | 90-days post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence