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Older PeopleSAVENCT05626556

A Technology-based Intervention to Support Older Adults in Living Independently

A study testing SAVE system in people with Older People and Frailty, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The general objective of this study is to test the usability and efficiency of the SAVE prototype, a technology-based support for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Older People, Frailty
What is being tested?
SAVE system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesin 3 countries
Study dates
17 Oct 2022to 30 Jun 2023
Phase
Interventional
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Mini Mental State Evaluation (MMSE) between 21 and 24
  • Healthy or mild to moderate chronic illness or musculoskeletal disease
  • Feel physically fit to participate in the study

Who cannot join

  • Participants suffer from severe chronic disease

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Hungary1 site

  • Országos Orvosi Rehabilitációs Intézet, Szanatórium

    Budapest

Other trials in Hungary

Italy1 site

  • IRCCS INRCA Hospital

    Ancona

Other trials in Italy

Romania1 site

  • Transilvania University of Brașov

    Brasov

Other trials in Romania

About this study

Official title: A Technology-based Intervention to Support Older Adults in Living Independently: Protocol for a Cross-national Feasibility Pilot

The general objective of this study is to test the usability and efficiency of the SAVE prototype, a technology-based support for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible.

Read the detailed description

The SAVE system aims to offer technology-based support to older adults for staying in their familiar surroundings for as long as possible, while feeling safe and optimally cared for. The SAVE technology has been designed and developed according to the approach of the User Centered Design (UCD), which involves multiple interactions with users to under-stand their needs and preferences and to involve them in the design process for creating a truly useful and appreciated technological product. Secondarily, it supports informal caregivers, like relatives, in providing optimal care for their loved ones, while maintaining their professional and private life. The general objective of this study is to test the usability and efficiency of the SAVE prototype for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible. The study involves the use of the SAVE platform for a total of 21 consecutive days.The study involves the use of a mixed-methods approach, in which both qualitative (open questions) and quantitative (standardized tests) data will be collected, and three different measurements (T0, T1, T2) will be made during the period of use of the system. The data collection card will therefore be divided into two different sections, which correspond to the three different moments of detection: 1) at time 0, that is, before the start of the experi-mentation (T0); 2) at time 1, after 10 days, i.e. at the midterm of the trial (T1), and 3) at time 2, after 21 days, i.e., at the end of the trial (T2). The log data of the usage of the SAVE sys-tem be the primary, secondary, and tertiary users will be continuously stored over the 21 days test period.

Being tested
SAVE system
Keywords
technology-based intervention, older adults, active ageing
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAVE systemOther

    The SAVE system will be implemented in end users' homes. Flood sensors will be installed in the bathroom and kitchen, presence sensors in the living room and bedroom, and the contact sensor will be installed at the entrance door. For the best user experience, the installation of the required software (for the sensors kit and the smartwatch) was done on the users' own smartphones. Thus, at the end of the installation, users will have the Aqara Home System in their homes (5 sensors and a sensor hub), a Samsung smartwatch and a SAVE Sensors Adapter, all of which are connected to a router with unlimited internet access.

Study groups in NCT05626556
Study groupRoleWhat they receive
older adultsExperimentalOlder adults with mild to moderate chronic illness
Receives: Other: SAVE system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usability

    This outcome will be measured through the System Usability Scale (SUS). It consists of a 10-item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'.

    Measured: Change from baseline SUS at 21 days from the start of the intervention

  2. Acceptance

    This outcome will be measured through the the User Experience Questionnaire (UEQ). The UEQ is a semantic differential with 26 items. The scales of the questionnaire cover a comprehensive impression of user experience. Items are scored on a 7-point Likert scale and range from full agreement with the negative term (-3) to the full agreement with the positive term (+3). Half of the items start with the positive term, the rest with the negative term. Higher sum scores indicate more positive evaluation.

    Measured: Change from baseline UEQ at 21 days from the start of the intervention

Secondary outcomes (4)

  1. Cognitive impairment

    This outcome will be measured by Mini-Mental State Examination (MMSE). It is a neuropsychological test for the evaluation of disorders of intellectual efficiency and the presence of cognitive impairment. The total score is between a minimum of 0 and a maximum of 30 points. A score of 26 to 30 is an indication of cognitive normality. The score will be adjusted with the coefficient for age and schooling.

    Measured: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention

  2. Autonomy in walking

    This outcome will be measured by the Ambulation Category (FAC). It is a scale that evaluates the ability to autonomy in walking. The ambulatory capacity is evaluated with a score ranging from 0 to 5, where 0 indicates total dependence and 5 complete autonomy.

    Measured: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention

  3. Functional status

    This outcome will be measured by the Barthel Index. The individual is scored in a number of areas depending upon independence of performance. Total scores range from 0 (complete dependence) to 100 (complete independence).

    Measured: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention

  4. State of health

    This outcome will be measured by the SF-12v2 ™ Health Survey. It is a widely used instrument, and is a 12-element sub-set of the SF-36v2™. This is a generic assessment of the health-related quality of life from the patient's perspective. The mean score is set to 50. Scores >50 indicate better physical or mental health than the mean. Scores <50 indicate worse physical or mental health than the mean.

    Measured: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2022
  2. Study start17 Oct 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626556
Sponsor's protocol ID
INRCA_005_2022
Acronym
SAVE
Status last verified
Nov 2022
First submitted
11 Nov 2022
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stara V, Rampioni M, Mosoi AA, Kristaly DM, Moraru SA, Paciaroni L, Paolini S, Raccichini A, Felici E, Rossi L, Vizitiu C, Nistorescu A, Marin M, Tonay G, Toth A, Pilissy T, Fazekas G. A Technology-Based Intervention to Support Older Adults in Living Independently: Protocol for a Cross-National Feasibility Pilot. Int J Environ Res Public Health. 2022 Dec 10;19(24):16604. doi: 10.3390/ijerph192416604.

    PubMed 36554485

Questions about this trial

What is this clinical trial studying?

A study testing SAVE system in people with Older People and Frailty, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.

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 1 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hungary, Italy, Romania. 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?

Usability (time frame: Change from baseline SUS at 21 days from the start of the intervention). The study lists 2 primary outcomes in all. 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 NCT05626556, 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 23 Oct 2023.

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