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OpenTrials
Completed

NCT Number: NCT04130256

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Health Behavior Immune System Diseases Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic pill bottle

Device

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

Primary outcomes

  1. Rate of perfect adherence

    Time frame: 90-days post-enrollment

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

Secondary outcomes

  1. Participant satisfaction

    Time frame: 90-days post-enrollment

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Multiple Sclerosis Society
  • Pillsy, Inc.

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2019
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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