Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
Study NCT ID:
NCT02913092
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2016-09-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-18', 'studyFirstSubmitDate': '2016-09-18', 'studyFirstSubmitQcDate': '2016-09-21', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Control Test', 'timeFrame': 'change from baseline to 6 months', 'description': 'validated asthma control measure'}], 'secondaryOutcomes': [{'measure': 'Medication adherence', 'timeFrame': 'change from baseline to 6 months', 'description': 'measured by electronic sensor'}, {'measure': 'Health care utilization', 'timeFrame': 'change from baseline to 6 months', 'description': 'ED visits and hospitalizations will be assessed via electronic health records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control', 'detailedDescription': 'This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx.\n\nInvestigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma\n* Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year\n* Use of daily controller inhaler medications\n* Adult non-smokers, or lifetime use \\<5 pack years with no smoking in last 1 yr\n* Smartphone required\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* No smartphone\n* Use of oral corticosteroids in prior 4 weeks\n* Pregnancy\n* Psychiatric conditions'}, 'identificationModule': {'nctId': 'NCT02913092', 'briefTitle': 'Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma', 'orgStudyIdInfo': {'id': '2016-7001'}, 'secondaryIdInfos': [{'id': 'Community Service Award', 'type': 'OTHER_GRANT', 'domain': 'Stony Wold-Herbert Fund'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic sensor and OW education', 'description': "MDI sensor-generated alerts will be relayed and responded to (e.g. outreach worker contacts the participant for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide asthma education over the phone", 'interventionNames': ['Behavioral: Electronic sensor and OW education']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual care group will receive the electronic tracker but the sensor-generated alerts will not be delivered. If the usual care group rescue inhaler data reveals frequent use of rescue medication (daily use for \\>3 days) investigators will reach out (via app or phone call) to advise the participant to see their physician'}], 'interventions': [{'name': 'Electronic sensor and OW education', 'type': 'BEHAVIORAL', 'description': "MDI sensor-generated alerts will be relayed via app platform on participant's phone and responded to (e.g. outreach worker contacts the patient for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide education over the phone", 'armGroupLabels': ['Electronic sensor and OW education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Marina Reznik, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stony Wold-Herbert Fund, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Marina Reznik', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}