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.
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
- Are there results?
- Not yet: the study is under way
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.
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 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.
- 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.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- MEDEA SRL, Carol Davila University of Medicine and Pharmacy, Caritas Diocesana de Coimbra, Be-Com, SenLab d.o.o., Umana Persone
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active aGeing And Personalised Service's Ecosystem
- ClinicalTrials.gov ID
- NCT06859489
- Acronym / sponsor ID
- AGAPE / AGAPE
- Conditions
- Older People, Digital Health Literacy
- Keywords
- active and healthy ageing, digital health literacy, older adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- MEDEA SRL, Carol Davila University of Medicine and Pharmacy, Caritas Diocesana de Coimbra, Be-Com, SenLab d.o.o., Umana Persone
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| primary end-users | Experimental | Device: Active aGeing And Personalised service's Ecosystem (AGAPE)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. |
| formal caregiver | Other | Device: Active aGeing And Personalised service's Ecosystem (AGAPE)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. |
| informal caregiver | Other | Device: Active aGeing And Personalised service's Ecosystem (AGAPE)Informal caregivers will be able to receive notifications of any anomalies on their devices and, if necessary, draw the attention of the formal caregiver. |
| Tertiary end users | Other | Device: Active aGeing And Personalised service's Ecosystem (AGAPE)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Tertiary end users, formal caregiver, informal caregiver, primary end-users |
Primary outcome
System Usability Scale (SUS)
Time frame: From the enrollment to the end of treatment at 12 months (T2)
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.
System Usability Scale (SUS)
Time frame: From the enrollment to 6 months (T1)
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.
System Usability Scale (SUS)
Time frame: 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
Time frame: From the enrollment to 6 months (T1)
the aim of the questionnaire is recording the socio-demographic charateristics of the sample
Ad Hoc socio-demographic questionnaire
Time frame: From the enrollment to 12 months (T2)
the aim of the questionnaire is recording the socio-demographic charateristics of the sample
Ad Hoc socio-demographic questionnaire
Time frame: From the enrollment to 1 month (T0)
the aim of the questionnaire is recording the socio-demographic charateristics of the sample
TechnoStress Questionnaire
Time frame: From the enrollment to 12 months (T2)
it's a psychological questionnaire designed to measure the level of stress related to the use of technology.
TechnoStress Questionnaire
Time frame: From the enrollment to1 month (T0)
it's a psychological questionnaire designed to measure the level of stress related to the use of technology
TechnoStress Questionnaire
Time frame: 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
Questionnaire for Innovation Adoption
Time frame: From the enrollment to1 month (T0)
it explores how and why individuals decide to embrace or reject innovation such as technology
Questionnaire for Innovation Adoption
Time frame: From the enrollment to 6 months (T1)
it explores how and why individuals decide to embrace or reject innovation such as technology
Questionnaire for Innovation Adoption
Time frame: From the enrollment to 12 months (T2)
it explores how and why individuals decide to embrace or reject innovation such as technology
EQ-5D-5L
Time frame: From the enrollment to1 month (T0)
this questionnaire explores the quality of life for european samples. Answer: 1 (no problems) to 5 (extreme problems).
EQ-5D-5L
Time frame: From the enrollment to 12 months (T2)
this questionnaire explores the quality of life for european samples. Answer: 1 (no problems) to 5 (extreme problems).
EQ-5D-5L
Time frame: 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
Time frame: From the enrollment to 6 months (T1)
this scale is used for investigate the loneliness of the sample. Answer: 0 (Never) to 3 (Often).
UCLA Loneliness Scale
Time frame: From the enrollment to1 month (T0)
this scale is used for investigate the loneliness of the sample. Answer: 0 (Never) to 3 (Often).
UCLA Loneliness Scale
Time frame: From the enrollment to 12 months (T2)
this scale is used for investigate the loneliness of the sample. Answer: 0 (Never) to 3 (Often).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: From the enrollment to the end of treatment at 12 months (T2)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.