Older PeopleAGAPENCT06859489

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

A study testing Active aGeing And Personalised service's Ecosystem (AGAPE) in people with Older People and Digital Health Literacy, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

Who is it for?: Ages 65 years and older
Conditions the study is for: Older People, Digital Health Literacy
What is being tested?: Active aGeing And Personalised service's Ecosystem (AGAPE)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteItaly
Study dates: 6 Feb 2024to 31 Mar 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Fondazione Don Carlo Gnocchi, Firenze
Florence

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions: Older People, Digital Health Literacy
Being tested: Active aGeing And Personalised service's Ecosystem (AGAPE)
Keywords: active and healthy ageing, digital health literacy, older adults
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active aGeing And Personalised service's Ecosystem (AGAPE)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.

Study groups in NCT06859489
Study group	Role	What they receive
primary end-users	Experimental	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. Receives: Device: Active aGeing And Personalised service's Ecosystem (AGAPE)
formal caregiver	Other	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. Receives: Device: Active aGeing And Personalised service's Ecosystem (AGAPE)
informal caregiver	Other	Informal caregivers will be able to receive notifications of any anomalies on their devices and, if necessary, draw the attention of the formal caregiver. Receives: Device: Active aGeing And Personalised service's Ecosystem (AGAPE)
Tertiary end users	Other	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. Receives: Device: Active aGeing And Personalised service's Ecosystem (AGAPE)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: From the enrollment to 1 month (T0)
Ad Hoc socio-demographic questionnaire
the aim of the questionnaire is recording the socio-demographic charateristics of the sample
Measured: 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
Measured: 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
Measured: 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.
Measured: From the enrollment to 12 months (T2)
TechnoStress Questionnaire
it's a psychological questionnaire designed to measure the level of stress related to the use of technology
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From the enrollment to 12 months (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 202431 Mar 2025

First posted5 Mar 2025
Study start6 Feb 2024
Primary completion13 Nov 2024
Study completion31 Mar 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Older PeopleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06859489
Sponsor's protocol ID: AGAPE
Acronym: AGAPE
Status last verified: Feb 2025
First submitted: 28 Feb 2025
Last updated: 13 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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