Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT04130256
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized 1:1 trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of perfect adherence', 'timeFrame': '90-days post-enrollment', 'description': 'Perfect adherence is defined as taking all scheduled pills +/-3 hours of scheduled dosing time'}], 'secondaryOutcomes': [{'measure': 'Participant satisfaction', 'timeFrame': '90-days post-enrollment', 'description': 'Participant satisfaction with the use of an electronic pill bottle and app'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication adherence'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '23383731', 'type': 'BACKGROUND', '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.'}, {'pmid': '29988735', 'type': 'BACKGROUND', '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.'}, {'pmid': '30138155', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide individual written consent\n* Ability to understand sufficient levels of English to use the Pillsy app\n* 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\n* Possess a smartphone\n* Willingness to follow the study protocol\n\nExclusion Criteria:\n\n* Presence of an MS relapse requiring acute management and/or hospitalization\n* Daily medication provided by allied health care workers\n* Foreign travel preventing electronic remote monitoring\n* Expectation of discontinuation of the oral disease modifying therapy (DMT) in the upcoming 90 days for any reason'}, 'identificationModule': {'nctId': 'NCT04130256', 'briefTitle': 'Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '2018P001820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Reminders', '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.', 'interventionNames': ['Device: Electronic Pill Bottle']}, {'type': 'EXPERIMENTAL', 'label': 'Passive Adherence Monitoring', '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.', 'interventionNames': ['Device: Electronic Pill Bottle']}], 'interventions': [{'name': 'Electronic Pill Bottle', 'type': 'DEVICE', 'otherNames': ['Pillsy'], '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.', 'armGroupLabels': ['Active Reminders', 'Passive Adherence Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Multiple Sclerosis Society', 'class': 'OTHER'}, {'name': 'Pillsy, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology', 'investigatorFullName': 'Farrah Mateen', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}