Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT03734861
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2018-08-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhollenbach@connecticutchildrens.org', 'phone': '860-837-5333', 'title': 'Dr. Jessica Hollenbach, PhD', 'organization': "Connecticut Children's Medical Center, Asthma Center"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The intervention sample size was limited by the number of EMDs provided by CoHero. In addition, EMD adherence rates cannot directly be compared between the intervention and control groups because of the study design. Furthermore, at the initiation of the study, CoHero had not designed the BreatheSmart app for compatibility with Android smartphones. Thus, a significant proportion of potentially eligible children were18 excluded because of Android phone ownership.'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 3, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Caregiver-reported emergency department visit for asthma exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Days Covered (PDC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post start of intervention', 'description': 'Medication adherence among children using BreatheSmart with feedback (intervention) compared to control group (standard of care) at 6 months. The primary outcome was medication adherence as measured using pharmacy refill. Medication adherence as measured by pharmacy refills was calculated using proportion of days covered (PDC), a validated method of calculating adherence, defined as a ratio of the sum of unique days supplied based on refills over the total number of days in the assessed period.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the BreatheSmart arm (intervention) received the EMD, app, and reminder notifications. Participants in the control group continued to receive routine clinical care. They were reminded to adhere to prescribed therapy during their clinical encounters'}, {'type': 'SECONDARY', 'title': 'Asthma Control Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}], 'classes': [{'title': 'ACT baseline', 'categories': [{'measurements': [{'value': '18.9', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'ACT 3 months', 'categories': [{'measurements': [{'value': '21.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '20', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'ACT 6 months', 'categories': [{'measurements': [{'value': '19.7', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post start of intervention', 'description': "The Asthma control Test (ACT) assess a patient's level of asthma control based on responses to 5 symptom-related questions over the past 4 weeks. Respondents must select a number on a 5-point likert scale (1-5) for each item. The response to each question is summed, ranging from 5-25. Scores of 19 or less indicate poorly controlled asthma. Higher scores mean better asthma control.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intervention group received an electronic monitoring device (Herotracker), which is synced to the BreathSmart mobile app, designed to send reminder notifications to participants, and are able to collect medication adherence data. Participants are able to track and review their medication adherence using the app. Participants in the control group continued to receive routine clinical care. They were reminded to adhere to prescribed therapy during their clinical encounters.'}, {'type': 'SECONDARY', 'title': 'FEV1% Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n\nBreatheSmart System: ○ BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '89.7', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '92.4', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': '3-months', 'categories': [{'measurements': [{'value': '86.5', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '99.7', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'categories': [{'measurements': [{'value': '90.5', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '103.6', 'spread': '14.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months.', 'unitOfMeasure': 'percentage of predicted FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in both arms performed spirometry during clinic visits'}, {'type': 'SECONDARY', 'title': 'Changes in Medication Adherence and Lung Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}], 'classes': [{'title': 'FEV1% predicted', 'categories': [{'measurements': [{'value': '0.221', 'groupId': 'OG000'}, {'value': '0.283', 'groupId': 'OG001'}]}]}, {'title': 'FEV1/FVC', 'categories': [{'measurements': [{'value': '-0.081', 'groupId': 'OG000'}, {'value': '0.174', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 6 months post start of intervention', 'description': 'The correlation between changes in medication adherence and changes in FEV1 percent predicted.\n\nFEV1 is forced expiratory volume in 1 second is the maximum amount of air that a subject can forcibly expel during the first second following maximal inhalation. FEV1 can be useful to categorize the severity of asthma. Expressing FEV1 as a percentage of the predicted value in a patient is means by which to express this severity.', 'unitOfMeasure': "Spearman's correlation coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was comprised of children enrolled in either the control (standard of care) arm or the intervention (Breathesmart, HeroTracker) arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Visits to ER for Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n\nBreatheSmart System: ○ BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}], 'classes': [{'title': 'ED visits 3 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ED visits 6 months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 6 months post start of intervention', 'description': 'The overall number of participant-reported provider visits for asthma healthcare utilization (e.g. number of self-reported exacerbations leading to ER visits)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Missed Days of School', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}], 'classes': [{'title': 'Past 30 days from Baseline', 'categories': [{'measurements': [{'value': '1.12', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Past 30 days from 6-month follow-up', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last 30 days from baseline visit and last 30 days from 6-month follow-up visit', 'description': 'Average number of days missed from school in the past 30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n\nBreatheSmart System: ○ BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.\n\nStandard of Care: These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '3', 'groupId': 'BG000'}, {'value': '11.7', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '12', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Proportion of days covered (PDC)', 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '0.30', 'groupId': 'BG000'}, {'value': '0.41', 'spread': '0.27', 'groupId': 'BG001'}, {'value': '0.41', 'spread': '0.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The primary outcome is medication adherence as measured using pharmacy refills. Medication adherence as measured by pharmacy refills was calculated using proportion of days covered (PDC), a validated method of calculating adherence, defined as a ratio of the sum of unique days supplied based on refills over the total number of days in the assessed period. For baseline adherence, PDC was assessed over a six-month period prior to the enrollment date.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-12', 'size': 942697, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-13T11:52', 'hasProtocol': True}, {'date': '2019-09-04', 'size': 578877, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-08T08:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to one of two arms:\n\n1. BreathSmart system\n2. Standard of Care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2018-08-30', 'resultsFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-06', 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Days Covered (PDC)', 'timeFrame': '6 months post start of intervention', 'description': 'Medication adherence among children using BreatheSmart with feedback (intervention) compared to control group (standard of care) at 6 months. The primary outcome was medication adherence as measured using pharmacy refill. Medication adherence as measured by pharmacy refills was calculated using proportion of days covered (PDC), a validated method of calculating adherence, defined as a ratio of the sum of unique days supplied based on refills over the total number of days in the assessed period.'}], 'secondaryOutcomes': [{'measure': 'Asthma Control Test', 'timeFrame': '6 months post start of intervention', 'description': "The Asthma control Test (ACT) assess a patient's level of asthma control based on responses to 5 symptom-related questions over the past 4 weeks. Respondents must select a number on a 5-point likert scale (1-5) for each item. The response to each question is summed, ranging from 5-25. Scores of 19 or less indicate poorly controlled asthma. Higher scores mean better asthma control."}, {'measure': 'FEV1% Predicted', 'timeFrame': 'Baseline to 6 months', 'description': 'The percent predicted forced expiratory volume in 1 second (FEV1) were evaluated at baseline, 3-months, and 6-months.'}, {'measure': 'Changes in Medication Adherence and Lung Function', 'timeFrame': 'Baseline to 6 months post start of intervention', 'description': 'The correlation between changes in medication adherence and changes in FEV1 percent predicted.\n\nFEV1 is forced expiratory volume in 1 second is the maximum amount of air that a subject can forcibly expel during the first second following maximal inhalation. FEV1 can be useful to categorize the severity of asthma. Expressing FEV1 as a percentage of the predicted value in a patient is means by which to express this severity.'}, {'measure': 'Number of Participants With Visits to ER for Asthma', 'timeFrame': 'Baseline to 6 months post start of intervention', 'description': 'The overall number of participant-reported provider visits for asthma healthcare utilization (e.g. number of self-reported exacerbations leading to ER visits)'}, {'measure': 'Number of Missed Days of School', 'timeFrame': 'Last 30 days from baseline visit and last 30 days from 6-month follow-up visit', 'description': 'Average number of days missed from school in the past 30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '35691614', 'type': 'DERIVED', 'citation': 'Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.'}, {'pmid': '33644492', 'type': 'DERIVED', 'citation': 'Hollenbach J, Simoneau T, Sun Y, Becene I, Almeida S, Langton C, Flores G. Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma. Contemp Clin Trials Commun. 2021 Feb 6;21:100706. doi: 10.1016/j.conctc.2021.100706. eCollection 2021 Mar.'}]}, 'descriptionModule': {'briefSummary': 'Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to measure adherence forces clinicians and researchers to rely on patient-self report, which is notoriously inaccurate, to support clinical decision making. Many young patients suffer from both intentional and non-intentional non-adherence, thus an appropriate intervention must address both types. Current studies using electronic monitoring devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and thus are limited in their ability to engage patients for long-term behavior change.\n\nThis trial addresses an important knowledge gap by evaluating whether EMDs with a combination of reminder system and patient education can prove to be effective in increasing adherence rates and can be used in clinical practice to achieve better asthma control and outcomes through improved patient and clinician engagement.', 'detailedDescription': 'This is a prospective, randomized, controlled study of children with persistent asthma who are managed on daily inhaled corticosteroids (ICS). 75 children will be randomized 2:1 into one of two arms:\n\n* 50 children will be randomized to BreatheSmart, comprised of:\n\n * BreatheSmart mobile application that tracks medication usage and sends real time reminders\n * HeroTracker sensor that counts dosage and monitors real-time medication adherence\n * CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)\n* 25 children will be randomized to "standard of care"(control arm). These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 8 to 17\n* Diagnosis of persistent asthma\n* Prescribed an inhaled corticosteroid (ICS) for at least one month prior to enrollment\n* Use of a pressurized metered dose inhaler (pMDI) compatible with the Cohero mHealth Herotracker (See Appendix)\n* Parent/child possess a compatible smartphone (iOS 8.0 or higher)\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Presence of another chronic lung disease or condition such as cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, or presence of tracheostomy\n* Presence of other chronic medical condition such as congenital heart disease or immunodeficiency\n* Presence of other comorbidities that, in the opinion of the investigator, will interfere with collection of study procedures, or limits life expectancy to \\< 1 year\n* Currently pregnant or planning to become pregnant during the trial period'}, 'identificationModule': {'nctId': 'NCT03734861', 'briefTitle': 'The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': 'A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback', 'orgStudyIdInfo': {'id': '17-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BreatheSmart System', 'description': '* BreatheSmart mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)', 'interventionNames': ['Device: BreatheSmart System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'BreatheSmart System', 'type': 'DEVICE', 'description': '* BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders\n* HeroTracker sensor that counts dosage and monitors real-time medication adherence\n* CoheroConnect provider portal that allows the Investigator to monitor adherence', 'armGroupLabels': ['BreatheSmart System']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Tregony Simoneau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Connecticut Childrens Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'NA we are not planning on sharing the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}