Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00743418
Status:
UNKNOWN
Last Update Posted:
2008-08-28
First Post:
2008-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057233', 'term': 'Radio Frequency Identification Device'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D010355', 'term': 'Patient Identification Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2008-08-27', 'studyFirstSubmitDate': '2008-08-27', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation tools include: Geriatric Depression Scale, functional health questionnaire (SF-36), Emotional well-being questionnaire (Positive and Negative Affect Schedule; PANAS), single Life Satisfaction question and the Zarit Burden Interview', 'timeFrame': 'Before and after interventions'}]}, 'conditionsModule': {'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '18366748', 'type': 'BACKGROUND', 'citation': "Shoval N, Auslander GK, Freytag T, Landau R, Oswald F, Seidl U, Wahl HW, Werner S, Heinik J. The use of advanced tracking technologies for the analysis of mobility in Alzheimer's disease and related cognitive diseases. BMC Geriatr. 2008 Mar 26;8:7. doi: 10.1186/1471-2318-8-7."}]}, 'descriptionModule': {'briefSummary': 'The research is aimed at exploring the application of novel tracking technique for the study of spatial activity among dementia patients and its implication on their families. The study sample will be composed of three groups of volunteers, each including100 participants aged over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The second group will include patients that suffer from mild dementia. The third group will include age matched healthy participants. The tracking equipment will be a GPS apparatus of 450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data will be transferred via the cellular network to operator center at the Hebrew university at Jerusalem, and will be documented in assigned data files. This monitoring procedure will be held every year and along a period of five years. The impact of the patient behavior on the care giver will be studied by means of five interviews along the tracking period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with MCI, Alzheimer's disease, or mixed type dementia; OR\n* Healthy control subjects who meet the following criteria:\n\n * Mini Mental State (MMSE) of at least 21\n * Age 60 years or older\n * Patients with history of stroke which is not followed by cognitive decline may be included\n * Fluent language skills\n\nExclusion Criteria:\n\n* Other dementias (e.g. vascular, frontotemporal, metabolic etc);\n* Other major psychiatric disorders (e.g. major depression, schizophrenia);\n* Substance abuse;\n* MMSE 20 or less;\n* Severe motor disturbances;\n* Sensory deficits potentially affecting mobility; OR\n* Severe physical disorders (e.g. cancer, major operation)"}, 'identificationModule': {'nctId': 'NCT00743418', 'acronym': 'SenTra', 'briefTitle': "Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': "The Use of Advanced Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease and Related Cognitive Disorders", 'orgStudyIdInfo': {'id': 'DIP-K.3.1.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Healthy controls Mini Mental State evaluation score \\>28/30', 'interventionNames': ['Device: GPS modem and RFID']}, {'type': 'OTHER', 'label': '2', 'description': 'Mild Cognitive Impairment: Mini Mental State Evaluation Score (MMSE)=26-28/30', 'interventionNames': ['Device: GPS modem and RFID']}, {'type': 'OTHER', 'label': '3', 'description': 'Mild Dementia: Mini Mental State Evaluation Score (MMSE)=21-25/30', 'interventionNames': ['Device: GPS modem and RFID']}], 'interventions': [{'name': 'GPS modem and RFID', 'type': 'DEVICE', 'description': 'The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jeremia Heinik, MD', 'role': 'CONTACT', 'email': 'jeremiah@tasmc.health.gov.il', 'phone': '972-3-6974817'}, {'name': 'Jeremia Heinik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Psychogeriatric clinic, Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Jeremia Heinik, MD', 'role': 'CONTACT', 'email': 'jeremiah@tasmc.health.gov.il', 'phone': '972-3-6974817'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': "Dr' Jeremia Heinik", 'oldOrganization': 'Psychogeriatric clinic, Sourasky Medical Center, Tel-Aviv Israel'}}}}