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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04130256
Collaborator
National Multiple Sclerosis Society (Other), Pillsy, Inc. (Other)
85
Enrollment
1
Location
2
Arms
14.4
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Electronic Pill Bottle
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized 1:1 trialRandomized 1:1 trial
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis
Actual Study Start Date :
Nov 15, 2019
Actual Primary Completion Date :
Jan 26, 2021
Actual Study Completion Date :
Jan 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Reminders

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
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.
Other Names:
  • Pillsy

    		•
    Experimental: Passive Adherence Monitoring

    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
    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.
    Other Names:
  • Pillsy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of perfect adherence [90-days post-enrollment]

      Perfect adherence is defined as taking all scheduled pills +/-3 hours of scheduled dosing time

    Secondary Outcome Measures

    1. Participant satisfaction [90-days post-enrollment]

      Participant satisfaction with the use of an electronic pill bottle and app

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • National Multiple Sclerosis Society
    • Pillsy, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Farrah Mateen, Associate Professor of Neurology, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04130256
    Other Study ID Numbers:
    • 2018P001820
    First Posted:
    Oct 17, 2019
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Farrah Mateen, Associate Professor of Neurology, Massachusetts General Hospital
    Medication adherence
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jul 30, 2021