Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-02 @ 4:50 AM
Study NCT ID:
NCT05112757
Status:
TERMINATED
Last Update Posted:
2022-12-12
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effective Conversion of Individuals at Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'whyStopped': 'Very low recruitment success and all recruitment options were exhausted', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-08', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective conversion', 'timeFrame': '6 months after consent', 'description': 'Number of patients that visited the Primary Care Physician'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OSA', 'AFib'], 'conditions': ['Obstructive Sleep Apnea', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis', 'detailedDescription': "The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health\n* 18 years or older, with sufficient English language skills\n* Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11\\<)\n* Able to download and handle an app on a smartphone\n* Willing and able to give informed consent\n\nExclusion criteria:\n\n* Diagnosed with OSA and/or AFib\n* Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)\n* Pregnancy/breast feeding"}, 'identificationModule': {'nctId': 'NCT05112757', 'briefTitle': 'Effective Conversion of Individuals at Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Electronics Nederland B.V. acting through Philips CTO organization'}, 'officialTitle': 'Effective Conversion of Individuals at Risk', 'orgStudyIdInfo': {'id': 'ICBE-S-000283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Smartphone app use', 'interventionNames': ['Other: Smartphone application use']}], 'interventions': [{'name': 'Smartphone application use', 'type': 'OTHER', 'description': 'Use of a smartphone application', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sandford Health', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Tim Weysen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philips Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Electronics Nederland B.V. acting through Philips CTO organization', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanford Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}