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

Primary Purpose

Older People, Frailty

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SAVE system
Sponsored by
Istituto Nazionale di Ricovero e Cura per Anziani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Older People focused on measuring technology-based intervention, older adults, active ageing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Országos Orvosi Rehabilitációs Intézet, Szanatórium
  • IRCCS INRCA Hospital
  • Transilvania University of Brașov

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

older adults

Arm Description

Older adults with mild to moderate chronic illness

Outcomes

Primary Outcome Measures

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'.
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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
November 11, 2022
Last Updated
October 19, 2023
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborators
European Union
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1. Study Identification

Unique Protocol Identification Number
NCT05626556
Brief Title
A Technology-based Intervention to Support Older Adults in Living Independently
Acronym
SAVE
Official Title
A Technology-based Intervention to Support Older Adults in Living Independently: Protocol for a Cross-national Feasibility Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborators
European Union

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older People, Frailty
Keywords
technology-based intervention, older adults, active ageing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
older adults
Arm Type
Experimental
Arm Description
Older adults with mild to moderate chronic illness
Intervention Type
Other
Intervention Name(s)
SAVE system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usability
Description
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'.
Time Frame
Change from baseline SUS at 21 days from the start of the intervention
Title
Acceptance
Description
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.
Time Frame
Change from baseline UEQ at 21 days from the start of the intervention
Secondary Outcome Measure Information:
Title
Cognitive impairment
Description
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.
Time Frame
at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
Title
Autonomy in walking
Description
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.
Time Frame
at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
Title
Functional status
Description
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).
Time Frame
at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
Title
State of health
Description
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.
Time Frame
at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Országos Orvosi Rehabilitációs Intézet, Szanatórium
City
Budapest
Country
Hungary
Facility Name
IRCCS INRCA Hospital
City
Ancona
Country
Italy
Facility Name
Transilvania University of Brașov
City
Brașov
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

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

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