Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06752512
Status:
RECRUITING
Last Update Posted:
2024-12-30
First Post:
2024-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Temperature Monitoring of Patients At Risk for Developing Fever
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-22', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2024-12-22', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean number of inpatient days', 'timeFrame': 'Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment', 'description': 'The number of days the participant was admitted to a hospital while receiving remote patient monitoring'}], 'secondaryOutcomes': [{'measure': 'Mean out-of-pocket cost', 'timeFrame': 'Day of enrollment', 'description': "The patient's out-of-pocket expense for setup of remote patient monitoring"}, {'measure': 'Number of CPT codes generated', 'timeFrame': 'Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment', 'description': 'Number of CPT codes generated for remote patient monitoring'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['fever', 'infection', 'sepsis', 'cancer', 'chemotherapy', 'immunocompromised', 'temperature', 'wearable', 'remote patient monitoring'], 'conditions': ['Fever', 'Cancer', 'Remote Patient Monitoring']}, 'descriptionModule': {'briefSummary': 'The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are:\n\n* does remote temperature monitoring reduce the number of days spent inpatient\n* what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring\n* the number of billable CPT codes that will be generated by providing remote temperature monitoring\n\nResearchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient.\n\nPatients will\n\n* wear the thermometer for the duration of their participation in the study\n* have their temperature monitored continuously\n* receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician\n* respond to texts or calls from remote monitors when an alert is triggered'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at risk of a fever post discharge.\n* Subject is ≥ 18 years or older.\n* Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.\n* Subject is willing to install the TempShield app on his/her phone.\n* Subject is willing to allow AION to send text reminders to take temperature or complete surveys.\n* Subject is willing to take an oral temperature as directed by their care plan.\n* Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.\n* Subject or subject caretaker is able and willing to complete subject surveys.\n* Subject is willing and able to provide written informed consent in English.\n* Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires.\n* English speakers\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)\n* Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)\n* Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.\n* Subjects receiving prophylactics that could induce fever.\n* Subjects with a silicon allergy\n* Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device.\n* Subjects who are not willing to take an oral temperature per their care plan.'}, 'identificationModule': {'nctId': 'NCT06752512', 'briefTitle': 'Remote Temperature Monitoring of Patients At Risk for Developing Fever', 'organization': {'class': 'INDUSTRY', 'fullName': 'AION Biosystems'}, 'officialTitle': 'Remote Temperature Monitoring of Patients At Risk for Developing Fever', 'orgStudyIdInfo': {'id': 'ELLIS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Patient Monitoring', 'description': 'Patients assigned remote patient monitoring', 'interventionNames': ['Device: Remote Patient Monitoring']}], 'interventions': [{'name': 'Remote Patient Monitoring', 'type': 'DEVICE', 'otherNames': ['RPM'], 'description': '24/7 remote patient monitoring with a wearable thermometer', 'armGroupLabels': ['Remote Patient Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12308', 'city': 'Schenectady', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elise Currier', 'role': 'CONTACT', 'email': 'curriere4s@ellismedicine.org', 'phone': '(704) 307-1253'}], 'facility': 'Ellis Hospital', 'geoPoint': {'lat': 42.81424, 'lon': -73.93957}}], 'centralContacts': [{'name': 'David Colburn, Ph.D.', 'role': 'CONTACT', 'email': 'd.alexander.colburn@aionbioystems.com', 'phone': '(757) 641-2019'}], 'overallOfficials': [{'name': 'Tallat Mahmood, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ellis Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AION Biosystems', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ellis Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}