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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05626556
Acronym
SAVE
Enrollment
80
Registered
2022-11-23
Start date
2022-10-17
Completion date
2023-06-30
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Older People

Keywords

technology-based intervention, older adults, active ageing

Brief 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.

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.

Interventions

OTHERSAVE system

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.

Sponsors

European Union
CollaboratorOTHER
Istituto Nazionale di Ricovero e Cura per Anziani
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Participants suffer from severe chronic disease

Design outcomes

Primary

MeasureTime frameDescription
UsabilityChange from baseline SUS at 21 days from the start of the interventionThis 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'.
AcceptanceChange from baseline UEQ at 21 days from the start of the interventionThis 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.

Secondary

MeasureTime frameDescription
Cognitive impairmentat baseline, at 10 days from the start of the intervention and at 21 days from the start of the interventionThis 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.
Autonomy in walkingat baseline, at 10 days from the start of the intervention and at 21 days from the start of the interventionThis 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.
Functional statusat baseline, at 10 days from the start of the intervention and at 21 days from the start of the interventionThis 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).
State of healthat baseline, at 10 days from the start of the intervention and at 21 days from the start of the interventionThis 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.

Countries

Hungary, Italy, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026