Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 11:54 PM
Study NCT ID:
NCT01217268
Status:
WITHDRAWN
Last Update Posted:
2018-09-07
First Post:
2010-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Telemedicine in Collaboration Between a Psychogeriatric Unit and Nursing Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2010-09-22', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychiatric inventory - nursing home version (NPI-NH)', 'timeFrame': 'week 48', 'description': "The investigators want to find out if a supervision of staff members over a six months time, using video-conference technic, contributes to improvement in patients' behaviour registered by NPI-NH"}], 'secondaryOutcomes': [{'measure': 'Person-centered Care Assessment Tool (P-CAT) Person centered care assessment tool (P-CAT)', 'timeFrame': 'week 48', 'description': 'Measures the effect of our intervention related to apply person centred dementia care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dementia', 'Behavioural Disorders']}, 'descriptionModule': {'briefSummary': 'The investigators want to evaluate the use of video-conference in the collaboration between the investigators psychogeriatric department and nursing homes. The study aim is to give supervision on a regular basis to the caregivers on a special care unit for patients with dementia with behavioural disturbances during a period of half a year. The investigators want to investigate the impact on caregivers and patients by applying certain tests at baseline, during the intervention and half a year after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being resident in a special care unit for persons with dementia\n\nExclusion Criteria:\n\n* Shorter stay than four weeks before inclusion\n* terminally ill'}, 'identificationModule': {'nctId': 'NCT01217268', 'acronym': 'TESAM', 'briefTitle': 'Use of Telemedicine in Collaboration Between a Psychogeriatric Unit and Nursing Homes', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset Innlandet HF'}, 'officialTitle': 'Use of Telemedicine in Collaboration Between a Psychogeriatric Unit and Nursing', 'orgStudyIdInfo': {'id': 'TESAM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training and supervision of staff', 'description': 'Staff members get training in person centered care by supervision using video-conference kit', 'interventionNames': ['Behavioral: Training in person centered care by supervision using video-conference']}], 'interventions': [{'name': 'Training in person centered care by supervision using video-conference', 'type': 'BEHAVIORAL', 'description': 'The investigators will use video-conference for supervising and training of staff members in nursing homes', 'armGroupLabels': ['Training and supervision of staff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2840', 'city': 'Reinsvoll', 'country': 'Norway', 'facility': 'Sykehuset Innlandet HF', 'geoPoint': {'lat': 60.67977, 'lon': 10.62175}}], 'overallOfficials': [{'name': 'Oskar H Sommer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SykehusetInnlandet, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Department of Health and Social Affairs', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Morten Lang-Ree, CEO', 'oldOrganization': 'Sykehuset Innlandet Health Trust'}}}}