Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-14 @ 6:54 AM
Study NCT ID:
NCT06417333
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '2 15 people groups were distributes wristbands during a 6 month span'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Each participant's written Mini Mental State Examination (MMSE) score was taken in the first and last week of data collection period", 'timeFrame': '3 months', 'description': 'The Mini Mental State Examination (MMSE) is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30, minimum is 0. A score of 24 or lower is indicative of cognitive impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia health data fitness tracking'], 'conditions': ['Dementia, Mild']}, 'descriptionModule': {'briefSummary': 'In this study, we developed a mobile application that will enable caregivers to continuously monitor the vital health, medication, activity, and location of the patients with MCI with a smart wristband while enabling them caregivers to track the progress of the disease by a machine learning model that predicts MMSE of the patient using speech', 'detailedDescription': "3-month vital health data collection has been performed on 30 participants who are over 60 years old via smart fitness wristbands distributed to them. A mobile application has been developed that caregivers can register their patients, wristbands and allow them to monitor their health data along with their location. medication and activities while synchronizing data anonymously to the application database.\n\nThe data collection has been performed with relatively cheap, simple Xiaomi MI Band 7 wristbands that track only HR, RHR, sleep, steps and move minutes due to reasonable price and light weight and easy wearability of these devices.\n\nMobile application synchronizes data from wristband to application servers continuously using Google Fit services that synchronize with device software. This made it possible for the patient's data to still be collected when he or she is not using any of them.\n\nMMSE scores of patients were taken at the beginning and at the end of the 3 month period to correlate scores with the collected aggregated health data and patient information"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older patients who are willing to wear a smart wristband and have an Android smart phone\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06417333', 'briefTitle': 'A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms', 'orgStudyIdInfo': {'id': '230086'}}, 'armsInterventionsModule': {'interventions': [{'name': 'xiaomi mi band 7 smart wristband', 'type': 'DEVICE', 'description': 'Patients with mild dementia have been distributed xiaomi mi band 7 smart wristbands for health data collection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sitki Kocman University - Dementia Clinic', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Tugba Suzek, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of The Bioinformatics Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Baris Ceyhan', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}