Multiple Sclerosis
Conditions
Keywords
Medication adherence
Brief summary
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
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.
Interventions
DEVICEElectronic Pill Bottle
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.
Sponsors
National Multiple Sclerosis Society
Pillsy, Inc.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomized 1:1 trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of perfect adherence | 90-days post-enrollment | Perfect adherence is defined as taking all scheduled pills +/-3 hours of scheduled dosing time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction | 90-days post-enrollment | Participant satisfaction with the use of an electronic pill bottle and app |
Countries
United States
Outcome results
None listed