Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-30 @ 8:18 PM
Study NCT ID:
NCT05828732
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006980', 'term': 'Hyperthyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}], 'ancestors': [{'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores of quality of life assessed by SF-36 survey', 'timeFrame': 'baseline (at enrollment)', 'description': 'Scores of quality of life assessed by SF-36 survey'}, {'measure': 'Scores of quality of life assessed by SF-36 survey', 'timeFrame': '6 weeks after baseline', 'description': 'Scores of quality of life assessed by SF-36 survey'}, {'measure': 'Scores of quality of life assessed by SF-36 survey', 'timeFrame': '10 weeks after baseline', 'description': 'Scores of quality of life assessed by SF-36 survey'}, {'measure': 'Scores of quality of life assessed by SF-36 survey', 'timeFrame': '14 weeks after baseline', 'description': 'Scores of quality of life assessed by SF-36 survey'}, {'measure': 'antithyroidal drug compliance', 'timeFrame': '6 weeks after baseline', 'description': 'Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.'}, {'measure': 'antithyroidal drug compliance', 'timeFrame': '10 weeks after baseline', 'description': 'Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.'}, {'measure': 'antithyroidal drug compliance', 'timeFrame': '14 weeks after baseline', 'description': 'Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.'}, {'measure': 'Knowledge about hyperthyroidism', 'timeFrame': '14 weeks after baseline', 'description': "A score measured through a test designed to assess the knowledge level about Graves' disease"}], 'secondaryOutcomes': [{'measure': 'free T4', 'timeFrame': 'baseline', 'description': 'serum free T4 concentration'}, {'measure': 'free T4', 'timeFrame': '6 weeks after baseline', 'description': 'serum free T4 concentration'}, {'measure': 'free T4', 'timeFrame': '10 weeks after baseline', 'description': 'serum free T4 concentration'}, {'measure': 'free T4', 'timeFrame': '14 weeks after baseline', 'description': 'serum free T4 concentration'}, {'measure': 'free T3', 'timeFrame': 'baseline', 'description': 'serum free T3 concentration'}, {'measure': 'free T3', 'timeFrame': '6 weeks after baseline', 'description': 'serum free T3 concentration'}, {'measure': 'free T3', 'timeFrame': '10 weeks after baseline', 'description': 'serum free T3 concentration'}, {'measure': 'free T3', 'timeFrame': '14 weeks after baseline', 'description': 'serum free T3 concentration'}, {'measure': 'TSH', 'timeFrame': 'baseline', 'description': 'serum free TSH concentration'}, {'measure': 'TSH', 'timeFrame': '6 weeks after baseline', 'description': 'serum free TSH concentration'}, {'measure': 'TSH', 'timeFrame': '10 weeks after baseline', 'description': 'serum free TSH concentration'}, {'measure': 'TSH', 'timeFrame': '14 weeks after baseline', 'description': 'serum free TSH concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperthyroidism']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study aims to investigate the effects of using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis. The study intends to evaluate how the use of the app affects disease progression, quality of life, and health-related behaviors associated with the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have been newly diagnosed or are currently undergoing treatment for thyrotoxicosis at Bundang Seoul National University Hospital.\n* Subjects must be able to use the smartphone app required for the use of wearable devices and their integration.\n\nExclusion Criteria:\n\n* Subjects who have constraints on normal activity due to diseases other than thyroid dysfunction.\n* Subjects who are currently taking medication that affects heart rate.\n* Subjects with heart conditions such as arrhythmia that affect heart rate.\n* Subjects who cannot undergo antithyroid drug treatment and require surgery or radioactive iodine therapy.'}, 'identificationModule': {'nctId': 'NCT05828732', 'briefTitle': 'Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism', 'orgStudyIdInfo': {'id': 'B-2201-735-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'app user group', 'description': 'The participants in this group start using wearable devices to monitor their heart rate and a mobile app to assist with the management of hyperthyroidism after being diagnosed and beginning treatment with anti-thyroid medication.', 'interventionNames': ['Other: Using a mobile app that integrates with wearable devices']}, {'type': 'NO_INTERVENTION', 'label': 'non-user group', 'description': 'The participants in this group begin treatment with anti-thyroid medication after being diagnosed with thyrotoxicosis, but they do not use the wearable devices or mobile app used in this study.'}], 'interventions': [{'name': 'Using a mobile app that integrates with wearable devices', 'type': 'OTHER', 'description': 'Using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis.', 'armGroupLabels': ['app user group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Hoon Moon, MD', 'role': 'CONTACT', 'email': 'jaemoon76@gmail.com', 'phone': '+82-31-787-7068'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Jae Hoon Moon, MD', 'role': 'CONTACT', 'email': 'jaemoon76@gmail.com', 'phone': '+82-31-787-7068'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'THYROSCOPE INC.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae Hoon Moon', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}