NCT04130256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

October 16, 2019

Last Update Submit

July 26, 2021

Conditions

Multiple Sclerosis

Keywords

Medication adherence

Outcome Measures

Primary Outcomes (1)

  • Rate of perfect adherence

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

    90-days post-enrollment

Secondary Outcomes (1)

  • Participant satisfaction

    90-days post-enrollment

Study Arms (2)

Active Reminders

EXPERIMENTAL

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

Passive Adherence Monitoring

EXPERIMENTAL

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

Interventions

Electronic Pill BottleDEVICE

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.

Also known as: Pillsy
Active RemindersPassive Adherence Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • 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.

    PMID: 23383731BACKGROUND

  • 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.

    PMID: 29988735BACKGROUND

  • 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.

    PMID: 30138155BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisMedication Adherence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized 1:1 trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 17, 2019

Study Start

November 15, 2019

Primary Completion

January 26, 2021

Study Completion

January 26, 2021

Last Updated

July 30, 2021

Record last verified: 2021-07

Locations

US(1)