Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-02 @ 4:07 AM
Study NCT ID:
NCT02130102
Status:
COMPLETED
Last Update Posted:
2015-12-31
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ModuLAAr - A Module Based and Scalable System for Silver-ager in Austria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2014-04-30', 'studyFirstSubmitQcDate': '2014-05-02', 'lastUpdatePostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of quality of life and subjective health', 'timeFrame': '4 and 1 months before intervention. 1, 4 and 12 months after intervention', 'description': 'multidimensional outcome assessment of quality of life: Quality of life is assessed by the questionnaires of the World Health Organization (WHOQOL-BREF and WHOQOL-OLD) as well as with semi-structured qualitative interviews. Subjective health is assessed by EQ-5D VAS of the Euroqol-Organization.'}], 'secondaryOutcomes': [{'measure': 'Changes in technology acceptance and usability', 'timeFrame': '1, 12 and 18 months after intervention', 'description': 'qualitative evaluation according to the technology acceptance model (TAM) and usability questionnaire'}, {'measure': 'Impact and changes on socio-economic parameters', 'timeFrame': '4 months before intervention. 4 and 12 months after intervention', 'description': 'user-questionnaire with socio-economic and socio-demographic parameters: (gender, income, housing conditions, level of education, level of social support, working experience, medicine intake, chronic diseases, frequency of falls, health threatening events).\n\nSemi-structured qualitative interviews using the delphi method will be conducted.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['technology acceptance', 'ambient assisted living', 'independent living', 'quality of life', 'socioeconomic impact', 'usability of information and communication technologies'], 'conditions': ['Quality of Life']}, 'referencesModule': {'references': [{'pmid': '25047720', 'type': 'DERIVED', 'citation': 'Siegel C, Prazak-Aram B, Kropf J, Kundi M, Dorner T. Evaluation of a modular scalable system for silver-ager located in assisted living homes in Austria--study protocol of the ModuLAAr ambient assisted living project. BMC Public Health. 2014 Jul 21;14:736. doi: 10.1186/1471-2458-14-736.'}], 'seeAlsoLinks': [{'url': 'http://www.modulaar.at', 'label': 'Website of the ModuLAAr project'}]}, 'descriptionModule': {'briefSummary': 'In this research project a module based Ambient Assisted Living solution will be provided to elderly living in assisted living homes. Those products and services seek to impact quality of life of the elderly and have positive effects on their environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'elderly residents of assisted living homes aged 60 and above', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years and older\n* informed consent\n* resident of an assisted living home of the Samariterbund Burgenland Rettung und Soziale Dienste GmbH\n\nExclusion Criteria:\n\n* relevant health threatening event or death\n* mini mental state score \\<17'}, 'identificationModule': {'nctId': 'NCT02130102', 'acronym': 'ModuLAAr', 'briefTitle': 'ModuLAAr - A Module Based and Scalable System for Silver-ager in Austria', 'organization': {'class': 'OTHER', 'fullName': 'AIT Austrian Institute of Technology GmbH'}, 'officialTitle': 'Evaluation of ModuLAAr - a Module Based and Scalable System for Silver-ager Located in Assisted Living Homes in Austria', 'orgStudyIdInfo': {'id': 'FFG Registration Nr. 835863'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Users of ModuLAAr', 'description': 'A group of volunteers (aged 60+), living in assisted living homes, will be provided with module based technical solutions to improve their independency and quality of life.', 'interventionNames': ['Device: The ModuLAAr Ambient Assisted Living System']}], 'interventions': [{'name': 'The ModuLAAr Ambient Assisted Living System', 'type': 'DEVICE', 'description': 'The system consists of the following modules which will be provided to the volunteers according to their needs:\n\ntablet computer (digital photo album, video telephone, meal ordering system, reminder system), bodyweight scale, blood pressure meter, emergency call system, mobile phone (documentation of personal health-related data), bathroom surveillance system, blood glucose meter, house automation technologies/smart home technologies', 'armGroupLabels': ['Users of ModuLAAr']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2700', 'city': 'Wiener Neustadt', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'AIT Austrian Institute of Technology GmbH', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}], 'overallOfficials': [{'name': 'Barbara Prazak-Aram, Mag.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIT Austrian Institute of Technology GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AIT Austrian Institute of Technology GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Samariterbund Burgenland Rettung und Soziale Dienste GmbH', 'class': 'UNKNOWN'}, {'name': 'University of Applied Sciences Technikum Wien', 'class': 'UNKNOWN'}, {'name': 'Austrian Research Promotion Agency', 'class': 'OTHER_GOV'}, {'name': 'Austrian Federal Ministry of Transport, Innovation and Technology (BMVIT)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Christian Siegel', 'investigatorAffiliation': 'AIT Austrian Institute of Technology GmbH'}}}}