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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Pill Bottle
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis focused on measuring Medication adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active Reminders

Passive Adherence Monitoring

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2019
Last Updated
July 26, 2021
Sponsor
Massachusetts General Hospital
Collaborators
National Multiple Sclerosis Society, Pillsy, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04130256
Brief Title
Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis
Official Title
Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
January 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Multiple Sclerosis Society, Pillsy, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Medication adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized 1:1 trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Reminders
Arm Type
Experimental
Arm 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.
Arm Title
Passive Adherence Monitoring
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Electronic Pill Bottle
Other Intervention Name(s)
Pillsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of perfect adherence
Description
Perfect adherence is defined as taking all scheduled pills +/-3 hours of scheduled dosing time
Time Frame
90-days post-enrollment
Secondary Outcome Measure Information:
Title
Participant satisfaction
Description
Participant satisfaction with the use of an electronic pill bottle and app
Time Frame
90-days post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23383731
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. doi: 10.18553/jmcp.2013.19.s1.S24.
Results Reference
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PubMed Identifier
29988735
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.
Results Reference
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PubMed Identifier
30138155
Citation
Erbay O, Usta Yesilbalkan O, Yuceyar 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.
Results Reference
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Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis

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