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Clinical Trials/NCT05626556
NCT05626556
Completed
Not Applicable

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

Istituto Nazionale di Ricovero e Cura per Anziani3 sites in 3 countries80 target enrollmentOctober 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Older People
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Enrollment
80
Locations
3
Primary Endpoint
Usability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Usability

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

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

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

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 Outcomes

  • Functional status(at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention)
  • State of health(at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention)
  • Autonomy in walking(at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention)
  • Cognitive impairment(at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention)

Study Sites (3)

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