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

Frailty Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05626556
• Other study ID #: INRCA_005_2022
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Older People

Intervention

Other:
• SAVE 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.

Locations

Country	Name	City	State
Hungary	Országos Orvosi Rehabilitációs Intézet, Szanatórium	Budapest
Italy	IRCCS INRCA Hospital	Ancona
Romania	Transilvania University of Bra?ov	Bra?ov

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani	European Union

Countries where clinical trial is conducted

Hungary,  Italy,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
Secondary	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.	at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
Secondary	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).	at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention
Secondary	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.	at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention