Clinical trial NCT05626556: A Technology-based Intervention to Support Older Adults in Living Independently
Official title: A Technology-based Intervention to Support Older Adults in Living Independently: Protocol for a Cross-national Feasibility Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older People
Frailty
Keywords: technology-based intervention
older adults
active ageing
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2022-11-23
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Usability
timeFrame: Change from baseline SUS at 21 days from the start of the intervention
measure: Acceptance
timeFrame: Change from baseline UEQ at 21 days from the start of the intervention
Secondary outcomes:
measure: Cognitive impairment
timeFrame: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
measure: Autonomy in walking
timeFrame: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
measure: Functional status
timeFrame: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
measure: State of health
timeFrame: at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Országos Orvosi Rehabilitációs Intézet, Szanatórium
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Brașov
country: Romania
facility: Transilvania University of Brașov
Study officials:
References: