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

NCT05626556 | Completed

• 1 other identifier: INRCA_005_2022
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 3

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.

Conditions

Older People; Frailty

Keywords

technology-based intervention; older adults; active ageing

Outcome Measures

Primary Outcomes (2)

• 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'.

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

• 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.

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

Secondary Outcomes (4)

• Cognitive impairment

  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

• 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

Study Arms (1)

older adults

EXPERIMENTAL

Older adults with mild to moderate chronic illness

Other: SAVE system

Interventions

SAVE system OTHER

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.

older adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants suffer from severe chronic disease

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• European Union: collaborator

Study Sites (3)

Országos Orvosi Rehabilitációs Intézet, Szanatórium

Budapest, Hungary

Location

IRCCS INRCA Hospital

Ancona, Italy

Location

Transilvania University of Brașov

Brasov, Romania

Location

Related Publications (1)

• 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.

  PMID: 36554485 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 23, 2022
• Study Start: October 17, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2022-11

Locations

HU (1); IT (1); RO (1)