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

Mass General Brigham

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Electronic Pill Bottle

Study type: Interventional

Funder types: Other

Identifiers

NCT04130256

2018P001820

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Active Reminders

Experimental group

Description:

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.

Treatment:

Device: Electronic Pill Bottle

Passive Adherence Monitoring

Experimental group

Description:

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.

Treatment:

Device: Electronic Pill Bottle