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 (AGAPE)

Active aGeing And Personalised Service's Ecosystem

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

Study Overview

• Status: Active, not recruiting
• Conditions: Older People; Digital Health Literacy
• Intervention / Treatment: Device: Active aGeing And Personalised service's Ecosystem (AGAPE)

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy
    • IRCCS Fondazione Don Carlo Gnocchi, Firenze

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: primary end-users; The Agape platform will offer a series of customized and integrated services to meet the needs of end users, including: promotion of a healthy and active lifestyle;; socialization services;; digital health literacy service.	Device: Active aGeing And Personalised service's Ecosystem (AGAPE); The experimental protocol is structured into two phases: Phase 1 (pre-pilot) - Preliminary assessment of the functionality and usability of the AGAPE platform by older adults and caregivers, divided into: Living lab: Three sessions to progressively explore and test the platform and its services, including workshop activities. Testing phase: Use of the platform in the home environment of older adults for one month. Phase 2 (pilot study) - Evaluation of the platform's impact on the daily lives of older adults, caregivers, and care organizations, with a 12-month involvement for each user.
Other: formal caregiver; formal caregivers are social operators with different background. The service provides support to formal caregivers in defining and updating the patient's activity plan over time, ensuring it adapts to their needs.	Device: Active aGeing And Personalised service's Ecosystem (AGAPE); The experimental protocol is structured into two phases: Phase 1 (pre-pilot) - Preliminary assessment of the functionality and usability of the AGAPE platform by older adults and caregivers, divided into: Living lab: Three sessions to progressively explore and test the platform and its services, including workshop activities. Testing phase: Use of the platform in the home environment of older adults for one month. Phase 2 (pilot study) - Evaluation of the platform's impact on the daily lives of older adults, caregivers, and care organizations, with a 12-month involvement for each user.
Other: informal caregiver; Informal caregivers will be able to receive notifications of any anomalies on their devices and, if necessary, draw the attention of the formal caregiver.	Device: Active aGeing And Personalised service's Ecosystem (AGAPE); The experimental protocol is structured into two phases: Phase 1 (pre-pilot) - Preliminary assessment of the functionality and usability of the AGAPE platform by older adults and caregivers, divided into: Living lab: Three sessions to progressively explore and test the platform and its services, including workshop activities. Testing phase: Use of the platform in the home environment of older adults for one month. Phase 2 (pilot study) - Evaluation of the platform's impact on the daily lives of older adults, caregivers, and care organizations, with a 12-month involvement for each user.
Other: Tertiary end users; Tertiary end users (i.e., care organizations, local authorities, municipalities). The Agape platform will offer a series of customized and integrated services to meet the needs of end users, including: promotion of a healthy and active lifestyle;; socialization services;; digital health literacy service.	Device: Active aGeing And Personalised service's Ecosystem (AGAPE); The experimental protocol is structured into two phases: Phase 1 (pre-pilot) - Preliminary assessment of the functionality and usability of the AGAPE platform by older adults and caregivers, divided into: Living lab: Three sessions to progressively explore and test the platform and its services, including workshop activities. Testing phase: Use of the platform in the home environment of older adults for one month. Phase 2 (pilot study) - Evaluation of the platform's impact on the daily lives of older adults, caregivers, and care organizations, with a 12-month involvement for each user.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ad Hoc socio-demographic questionnaire	the aim of the questionnaire is recording the socio-demographic charateristics of the sample	From the enrollment to 6 months (T1)
Ad Hoc socio-demographic questionnaire	the aim of the questionnaire is recording the socio-demographic charateristics of the sample	From the enrollment to 12 months (T2)
Ad Hoc socio-demographic questionnaire	the aim of the questionnaire is recording the socio-demographic charateristics of the sample	From the enrollment to 1 month (T0)
TechnoStress Questionnaire	it's a psychological questionnaire designed to measure the level of stress related to the use of technology	From the enrollment to1 month (T0)
TechnoStress Questionnaire	it's a psychological questionnaire designed to measure the level of stress related to the use of technology	From the enrollment to 6 months (T1)
Questionnaire for Innovation Adoption	it explores how and why individuals decide to embrace or reject innovation such as technology	From the enrollment to1 month (T0)
Questionnaire for Innovation Adoption	it explores how and why individuals decide to embrace or reject innovation such as technology	From the enrollment to 6 months (T1)
Questionnaire for Innovation Adoption	it explores how and why individuals decide to embrace or reject innovation such as technology	From the enrollment to 12 months (T2)
System Usability Scale (SUS)	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.	From the enrollment to the end of treatment at 12 months (T2)
System Usability Scale (SUS)	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.	From the enrollment to 6 months (T1)
System Usability Scale (SUS)	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.	From the enrollment to 1 month (T0)
TechnoStress Questionnaire	it's a psychological questionnaire designed to measure the level of stress related to the use of technology.	From the enrollment to 12 months (T2)
EQ-5D-5L	this questionnaire explores the quality of life for european samples. Answer: 1 (no problems) to 5 (extreme problems).	From the enrollment to1 month (T0)
EQ-5D-5L	this questionnaire explores the quality of life for european samples. Answer: 1 (no problems) to 5 (extreme problems).	From the enrollment to 12 months (T2)
EQ-5D-5L	this questionnaire explores the quality of life for european samples. Answer: 1 (no problems) to 5 (extreme problems).	From the enrollment to 6 months (T1)
UCLA Loneliness Scale	this scale is used for investigate the loneliness of the sample. Answer: 0 (Never) to 3 (Often).	From the enrollment to 6 months (T1)
UCLA Loneliness Scale	this scale is used for investigate the loneliness of the sample. Answer: 0 (Never) to 3 (Often).	From the enrollment to1 month (T0)
UCLA Loneliness Scale	this scale is used for investigate the loneliness of the sample. Answer: 0 (Never) to 3 (Often).	From the enrollment to 12 months (T2)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Carol Davila University of Medicine and Pharmacy; MEDEA SRL; Caritas Diocesana de Coimbra; Be-Com; SenLab d.o.o.; Umana Persone

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Actual): November 13, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: older adults; digital health literacy; active and healthy ageing
• Other Study ID Numbers: AGAPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No