Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-01 @ 2:11 PM
Study NCT ID:
NCT03648450
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regular device use at three months', 'timeFrame': 'The information will be collected at three months', 'description': 'This will be assessed by recording the number and percentage of the children and adolescents still using Propeller at three months.'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the Propeller EMD as determined by the electronic Medical Devices Assessment Toolkit (AMDAT)', 'timeFrame': 'Data will be captured at enrollment, one month and three months after enrollment', 'description': 'Acceptability will be determined by phone interview and survey response to the modified Adolescent Medical Devices Assessment Toolkit (AMDAT)'}, {'measure': 'Asthma Control', 'timeFrame': 'ACT will be assessed at enrollment, one month and three months.', 'description': 'Asthma control will be measured by the Asthma Control Test (range 0-25 with a higher score representing better asthma control). Change in ACT score will be assessed between baseline and one month and between baseline and three months. A change of 3 or more is considered a clinically significant change.'}, {'measure': 'Device use at one month', 'timeFrame': 'The information will be collected at one month', 'description': 'This will be assessed by recording the number and percentage of the children and adolescents still using the Propeller EMD at one month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The main hypothesis of this study is to see if children and adolescents with poorly controlled asthma will find the Propeller electronic monitoring device is feasible and acceptable, and will result in improved medication adherence and asthma control. Preliminary studies indicate that Propeller can improve medication adherence rates in children with asthma and reduce the number of days of reliever medication used. It also has been shown to reduce missed days of school and hospitalizations due to asthma exacerbations. The Propeller device is a sensor that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication. It also records use of the controller and rescue inhalers, allowing for parents, physicians, and patients to get a fuller and more accurate picture of their adherence to treatment and severity of disease. With improved adherence, asthma control should improve, resulting in a decreased costs and use of services.', 'detailedDescription': "This study is a prospective cohort study using a pre-/post-design.\n\nThe target population consists of children and adolescents 10-18 years old making an ED visit or admitted to the hospital at Connecticut Children's Medical Center for an asthma exacerbation.\n\nAll patients will receive two Propeller devices (for controller and rescue inhalers), an App for their smartphone, and a free Propeller subscription, which provides access support and services, and hardware and software updates. Only the children and adolescents involved with the study will have the app on their phone. The parents will not put the Propeller app on their phone. Families will be asked to share the study information with their primary care provider and will be provided with an introductory letter to bring to the provider, if they so choose.\n\nData collection will begin at enrollment and will continue through the three-month follow-up period. Propeller provides the option of continuous monitoring and data collection beyond study cessation.\n\nData uploads to the portal occur automatically for patients and caregivers who have installed the Propeller App on their smartphone. Additionally, patients' primary-care providers will receive a password allowing them to track and access participants' dashboard. Patients will bring a letter to their primary-care provider explaining that they are part of a study of Propeller's device, and receive instructions on how to view the dashboard and adherence data.\n\nAt enrollment, participants and parents will complete the Test of Adherence to Inhalers (TAI), Asthma Control Test (ACT) and PedsQL, along with providing baseline medical history/asthma history data and sociodemographic. The TAI, ACT and PedsQL surveys will again be completed one and three months post enrollment information. Additionally, participants will answer an adapted AMDAT survey that will be used to provide acceptability data about the Propeller device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The target population consists of children and adolescents 10-18 years old making an ED visit or admitted to the hospital at Connecticut Children's Medical Center for an asthma exacerbation.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Children in the ED or inpatient setting presenting with an asthma exacerbation between 10-18 years old\n2. History of persistent asthma (defined as prescribed a controller medication)\n3. Both the child and primary caregiver/parent have access to a cell phone with an activated number\n4. Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Child or parent has no access to a personal cell phone.\n2. The child has another chronic pulmonary condition (for example, cystic fibrosis)\n3. Having any chronic condition that could affect the child's ability to participate in the study (examples: cancer, autism, or cerebral palsy)\n4. The subject has an inhaler medication besides the following, given these are the current medications compatible with the Propeller EMD.\n\n i. Advair HFA ii. Flovent HFA iii. QVAR HFA v. Ventolin HFA vi. ProAir HFA"}, 'identificationModule': {'nctId': 'NCT03648450', 'briefTitle': 'Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': 'Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma', 'orgStudyIdInfo': {'id': 'Propeller Asthma Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Propeller Smart Inhaler EMD', 'description': 'All enrolled participants will be given the Propeller Smart Inhaler electronic monitoring device to use for three months to track how often they are using their inhalers either for their regular medication or as a rescue dose.', 'interventionNames': ['Other: Propeller EMD']}], 'interventions': [{'name': 'Propeller EMD', 'type': 'OTHER', 'description': 'Propeller electronic monitoring device is a sensor that fits on top of inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication.', 'armGroupLabels': ['Propeller Smart Inhaler EMD']}]}, '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': 'Glenn Flores, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Connecticut Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Jessica Hollenbach', 'investigatorAffiliation': "Connecticut Children's Medical Center"}}}}