Clinical trial NCT06859489: 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
Official title: Active aGeing And Personalised Service's Ecosystem
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Older People
Digital Health Literacy
Keywords: active and healthy ageing
digital health literacy
older adults
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: MEDEA SRL
name: Carol Davila University of Medicine and Pharmacy
name: Caritas Diocesana de Coimbra
name: Be-Com
name: SenLab d.o.o.
name: Umana Persone
First posted: 2025-03-05
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four categories of end users will be involved:

1. Primary end users (i.e., older adults);
2. Secondary end users, in the figure of informal caregivers (i.e., relatives and friends of the elderly);
3. Secondary end users, in the figure of formal caregivers (i.e., social and health workers with different professional trainings, such as nurses, home care workers, geriatricians etc...);
4. 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:

1. promotion of a healthy and active lifestyle;
2. socialization services;
3. digital health literacy service.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: From the enrollment to the end of treatment at 12 months (T2)
measure: System Usability Scale (SUS)
timeFrame: From the enrollment to 6 months (T1)
measure: System Usability Scale (SUS)
timeFrame: From the enrollment to 1 month (T0)
measure: Ad Hoc socio-demographic questionnaire
timeFrame: From the enrollment to 6 months (T1)
measure: Ad Hoc socio-demographic questionnaire
timeFrame: From the enrollment to 12 months (T2)
measure: Ad Hoc socio-demographic questionnaire
timeFrame: From the enrollment to 1 month (T0)
measure: TechnoStress Questionnaire
timeFrame: From the enrollment to 12 months (T2)
measure: TechnoStress Questionnaire
timeFrame: From the enrollment to1 month (T0)
measure: TechnoStress Questionnaire
timeFrame: From the enrollment to 6 months (T1)
measure: Questionnaire for Innovation Adoption
timeFrame: From the enrollment to1 month (T0)
measure: Questionnaire for Innovation Adoption
timeFrame: From the enrollment to 6 months (T1)
measure: Questionnaire for Innovation Adoption
timeFrame: From the enrollment to 12 months (T2)
measure: EQ-5D-5L
timeFrame: From the enrollment to1 month (T0)
measure: EQ-5D-5L
timeFrame: From the enrollment to 12 months (T2)
measure: EQ-5D-5L
timeFrame: From the enrollment to 6 months (T1)
measure: UCLA Loneliness Scale
timeFrame: From the enrollment to 6 months (T1)
measure: UCLA Loneliness Scale
timeFrame: From the enrollment to1 month (T0)
measure: UCLA Loneliness Scale
timeFrame: From the enrollment to 12 months (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi, Firenze
Study officials:
References: