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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02130102
Other study ID # FFG Registration Nr. 835863
Secondary ID
Status Completed
Phase N/A
First received April 30, 2014
Last updated December 30, 2015
Start date June 2013
Est. completion date December 2015

Study information

Verified date December 2015
Source AIT Austrian Institute of Technology GmbH
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 60 years and older

- informed consent

- resident of an assisted living home of the Samariterbund Burgenland Rettung und Soziale Dienste GmbH

Exclusion Criteria:

- relevant health threatening event or death

- mini mental state score <17

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
The ModuLAAr Ambient Assisted Living System
The system consists of the following modules which will be provided to the volunteers according to their needs: tablet 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

Locations

Country Name City State
Austria AIT Austrian Institute of Technology GmbH Wiener Neustadt Lower Austria

Sponsors (5)

Lead Sponsor Collaborator
AIT Austrian Institute of Technology GmbH Austrian Federal Ministry of Transport, Innovation and Technology (BMVIT), Austrian Research Promotion Agency, Samariterbund Burgenland Rettung und Soziale Dienste GmbH, University of Applied Sciences Technikum Wien

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of quality of life and subjective health 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. 4 and 1 months before intervention. 1, 4 and 12 months after intervention No
Secondary Changes in technology acceptance and usability qualitative evaluation according to the technology acceptance model (TAM) and usability questionnaire 1, 12 and 18 months after intervention No
Secondary Impact and changes on socio-economic parameters 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).
Semi-structured qualitative interviews using the delphi method will be conducted.
4 months before intervention. 4 and 12 months after intervention No
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