Active aGeing And Personalised Service's Ecosystem (AGAPE) Aims to Implement an Advanced Technology Platform That Provides Services to the Elderly, Formal and Informal Caregivers, and Caregiving Organizations

Not Applicable

Active, not recruiting

• Conditions: Older People; Digital Health Literacy

• Registration Number: NCT06859489
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

AGAPE aims to implement an advanced technology platform that provides services to older adults, formal and informal caregivers, and caregiving organizations.

Detailed Description

AGAPE aims to promote an active and healthy lifestyle in the over-65 population and, in parallel, to improve the quality of life of caregivers (by reducing the burden of care), while also overcoming the possible digital literacy gap of users. The advantage of the AGAPE platform is to offer users highly personalized services based on their needs and digital capabilities, and innovative technologies integrated with each other that fit within the spatial services already available in local ecosystems. The project involves an impact-by-design approach that engages older people, caregivers, and managers of care organizations in a co-creation strategy. In addition, the solutions offered by the AGAPE platform will be extensively tested in a preliminary pre-validation phase in order to effectively meet the needs of end users.

Study Timeline

• Study Start: 2024-02-06
• Primary Completion: 2024-11-13
• Status Verified: 2025-02
• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-05
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Age ≥ 65 years
• Ability to understand the rationale and characteristics of the study and to provide informed consent
• Low level of frailty, indicated by a score <5 on the Rockwood Clinical Frailty Scale (Rockwood et al., 2005)
• Absence of moderate to severe cognitive impairment, indicated by a Mini-Mental State Examination (MMSE) score ≥ 24 (adjusted score; Folstein, 1975)
• Absence of severe comorbidities and clinically relevant diseases

Exclusion Criteria

• Age below 65 years
• Inability to provide informed consent for participation in the study
• High level of frailty (Rockwood Clinical Frailty Scale > 5)
• Presence of cognitive impairment (adjusted MMSE score < 24)
• Diagnosed anxiety and depression
• Presence of severe disability and serious health conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
System Usability Scale (SUS)	From the enrollment to 1 month (T0)	Innovation adoption profile transition of the older adult, innovation adoption profile transition of the caregiver, evaluation of usability and technostress levels of the older adult and their respective caregivers in relation to the AGAPE platform, assessed using the SUS scale and the Technostress questionnaire throughout the different phases of the study.; Answer: 1 (strongly disagree) - 5 (strongly agree). Minimum= 10 ; Maximum= 50.
Ad Hoc socio-demographic questionnaire	From the enrollment to 1 month (T0)	the aim of the questionnaire is recording the socio-demographic charateristics of the sample
Questionnaire for Innovation Adoption	From the enrollment to 12 months (T2)	it explores how and why individuals decide to embrace or reject innovation such as technology
TechnoStress Questionnaire	From the enrollment to 6 months (T1)	it's a psychological questionnaire designed to measure the level of stress related to the use of technology
EQ-5D-5L	From the enrollment to 6 months (T1)	this questionnaire explores the quality of life for european samples. Answer: 1 (no problems) to 5 (extreme problems).
UCLA Loneliness Scale	From the enrollment to 12 months (T2)	this scale is used for investigate the loneliness of the sample. Answer: 0 (Never) to 3 (Often).

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi, Firenze; 🇮🇹 Firenze, Italy