Quality of LifeModuLAArNCT02130102
ModuLAAr - A Module Based and Scalable System for Silver-ager in Austria
An observational study of Quality of Life, run by AIT Austrian Institute of Technology GmbH at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- The ModuLAAr Ambient Assisted Living System
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 38 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: elderly residents of assisted living homes aged 60 and above
Who may be able to join
- 60 years and older
- informed consent
- resident of an assisted living home of the Samariterbund Burgenland Rettung und Soziale Dienste GmbH
Who cannot join
- relevant health threatening event or death
- mini mental state score <17
Trial locations and contacts
1 site in 1 country.
Austria1 site
AIT Austrian Institute of Technology GmbH
Wiener Neustadt, Lower Austria, 2700
About this study
Official title: Evaluation of ModuLAAr - a Module Based and Scalable System for Silver-ager Located in Assisted Living Homes in Austria
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.
- Conditions
- Quality of Life
- Being tested
- The ModuLAAr Ambient Assisted Living System
- Keywords
- technology acceptance, ambient assisted living, independent living, quality of life, socioeconomic impact, usability of information and communication technologies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ModuLAAr Ambient Assisted Living SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Users of ModuLAAr | 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. Receives: Device: The ModuLAAr Ambient Assisted Living System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 and 1 months before intervention. 1, 4 and 12 months after intervention
Secondary outcomes (2)
Changes in technology acceptance and usability
qualitative evaluation according to the technology acceptance model (TAM) and usability questionnaire
Measured: 1, 12 and 18 months after intervention
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.
Measured: 4 months before intervention. 4 and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIT Austrian Institute of Technology GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Samariterbund Burgenland Rettung und Soziale Dienste GmbH, University of Applied Sciences Technikum Wien, Austrian Research Promotion Agency, Austrian Federal Ministry of Transport, Innovation and Technology (BMVIT)
- Responsible party
- Principal investigator, Christian Siegel, AIT Austrian Institute of Technology GmbH
- Investigators
- Barbara Prazak-Aram, Mag., Principal investigator, AIT Austrian Institute of Technology GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130102
- Sponsor's protocol ID
- FFG Registration Nr. 835863
- Acronym
- ModuLAAr
- Status last verified
- Dec 2015
- First submitted
- 30 Apr 2014
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25047720
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ModuLAAr - a Module Based and Scalable System for Silver-ager Located in Assisted Living Homes in Austria
- ClinicalTrials.gov ID
- NCT02130102
- Acronym / sponsor ID
- ModuLAAr / FFG Registration Nr. 835863
- Conditions
- Quality of Life
- Keywords
- technology acceptance, ambient assisted living, independent living, quality of life, socioeconomic impact, usability of information and communication technologies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AIT Austrian Institute of Technology GmbHUniversity, hospital or other
- Collaborators
- Samariterbund Burgenland Rettung und Soziale Dienste GmbH, University of Applied Sciences Technikum Wien, Austrian Research Promotion Agency, Austrian Federal Ministry of Transport, Innovation and Technology (BMVIT)
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Users of ModuLAAr | – | Device: The ModuLAAr Ambient Assisted Living SystemA 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- elderly residents of assisted living homes aged 60 and above
Key inclusion criteria (3 listed)
- 60 years and older
- informed consent
- resident of an assisted living home of the Samariterbund Burgenland Rettung und Soziale Dienste GmbH
Key exclusion criteria (2 listed)
- relevant health threatening event or death
- mini mental state score <17
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ModuLAAr Ambient Assisted Living SystemThe 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 | Device | Users of ModuLAAr |
Primary outcome
Changes of quality of life and subjective health
Time frame: 4 and 1 months before intervention. 1, 4 and 12 months after intervention
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.
2 secondary outcomes
Changes in technology acceptance and usability
Time frame: 1, 12 and 18 months after intervention
Impact and changes on socio-economic parameters
Time frame: 4 months before intervention. 4 and 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Derived from this study: PubMed 25047720Siegel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Prazak-Aram, Mag. principal investigator
AIT Austrian Institute of Technology GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by AIT Austrian Institute of Technology GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of quality of life and subjective health (time frame: 4 and 1 months before intervention. 1, 4 and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02130102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.