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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130256
• Other study ID #: 2018P001820
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: January 26, 2021

Study information

• Verified date: July 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Multiple Sclerosis Society, Pillsy, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Erbay Ö, Usta Yesilbalkan Ö, Yüceyar N. Factors Affecting the Adherence to Disease-Modifying Therapy in Patients With Multiple Sclerosis. J Neurosci Nurs. 2018 Oct;50(5):291-297. doi: 10.1097/JNN.0000000000000395. — View Citation

Menzin J, Caon C, Nichols C, White LA, Friedman M, Pill MW. Narrative review of the literature on adherence to disease-modifying therapies among patients with multiple sclerosis. J Manag Care Pharm. 2013 Jan-Feb;19(1 Suppl A):S24-40. Review. — View Citation

Schreiber K, Kant M, Pfleger C, Jensen HB, Oesterberg O, Hald AR, Nielsen FK, Rubak S. High treatment adherence, satisfaction, motivation, and health-related quality of life with fingolimod in patients with relapsing-remitting multiple sclerosis - results from a 24-month, multicenter, open-label Danish study. Patient Prefer Adherence. 2018 Jun 29;12:1139-1150. doi: 10.2147/PPA.S166278. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of perfect adherence	Perfect adherence is defined as taking all scheduled pills +/-3 hours of scheduled dosing time	90-days post-enrollment
Secondary	Participant satisfaction	Participant satisfaction with the use of an electronic pill bottle and app	90-days post-enrollment