Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-02 @ 7:34 AM
Study NCT ID:
NCT03753568
Status:
UNKNOWN
Last Update Posted:
2019-03-25
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects are monitored first before the intervention and then during the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-11-22', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the medication', 'timeFrame': '8 months', 'description': 'PDC - proportion of days covered'}], 'secondaryOutcomes': [{'measure': 'Variation of daily pill taking times', 'timeFrame': '8 months', 'description': 'The mean difference from the mean pill taking time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medicine reminder', 'diabetes mellitus, type 2', 'direct oral anticoagulants'], 'conditions': ['Anticoagulant Drugs', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'In this study, the effect of an electronic device attached to a push through pill package and a smart phone application on chronic disease medication adherence is studied.', 'detailedDescription': "In this study study two different groups of medicine users are recruited. Both groups have 50 patients each. In the first study the participants are using oral medication for diabetes and in the second study the participants use new direct oral anticoagulants.\n\nParticipants use medicine reminder system consisting of an electronic device and an smart phone application. In the beginning of the study the reminder system is collecting data on how the patients are taking their medication for the first two months. Smart phone application is not providing any reminders and participants can't access the app to see the details.\n\nAfter two months the application will be unlocked so that it starts reminding the users to take their medication at the right time. in this phase the patients can view their medication data from the application. The reminder phase of the study lasts for two months. After these two plus two months, the results are analyzed and published.\n\nThe study continues after these four months for the next four months and after that, the long term results are analyzed.'\n\nThe primary outcome is the possible change in the adherence between control and active period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* use of direct oral anticoagulants or oral diabetic drugs\n* age of 18 or more\n* subjects have been using a smart phone\n\nExclusion Criteria:\n\n* patients who don't use their medication without help"}, 'identificationModule': {'nctId': 'NCT03753568', 'briefTitle': 'Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence', 'orgStudyIdInfo': {'id': '002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'The participants use either direct oral anticoagulants or oral diabetic medication.', 'interventionNames': ['Device: Electronic medicine reminder system']}], 'interventions': [{'name': 'Electronic medicine reminder system', 'type': 'DEVICE', 'description': 'Electronic surveillance device is attached to the participants push through pill sheet and the smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Leo Niskanen, M.D. Ph.D', 'role': 'CONTACT', 'email': 'leo.niskanen@fimnet.fi', 'phone': '+358500675727'}, {'name': 'Janne Sahlman, M.D. Ph.D', 'role': 'CONTACT', 'email': 'janne.m.sahlman@gmail.com', 'phone': '+358405586611'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief medical officer, Popit Ltd', 'investigatorFullName': 'Janne Sahlman', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}