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

NCT ID: NCT06859489

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-06

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Older People Digital Health Literacy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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primary end-users

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.

Group Type EXPERIMENTAL

Active aGeing And Personalised service's Ecosystem (AGAPE)

Intervention Type DEVICE

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.

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.

Group Type OTHER

Active aGeing And Personalised service's Ecosystem (AGAPE)

Intervention Type DEVICE

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.

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.

Group Type OTHER

Active aGeing And Personalised service's Ecosystem (AGAPE)

Intervention Type DEVICE

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.

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:

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

Group Type OTHER

Active aGeing And Personalised service's Ecosystem (AGAPE)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MEDEA SRL

UNKNOWN

Sponsor Role collaborator

Carol Davila University of Medicine and Pharmacy

OTHER

Sponsor Role collaborator

Caritas Diocesana de Coimbra

UNKNOWN

Sponsor Role collaborator

Be-Com

UNKNOWN

Sponsor Role collaborator

SenLab d.o.o.

UNKNOWN

Sponsor Role collaborator

Umana Persone

UNKNOWN

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Fondazione Don Carlo Gnocchi, Firenze

Florence, , Italy

Site Status

Countries

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Italy

Other Identifiers

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AGAPE

Identifier Type: -

Identifier Source: org_study_id

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