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

NCT06859489 | Active Not Recruiting

• 1 other identifier: AGAPE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Older People; Digital Health Literacy

Keywords

active and healthy ageing; digital health literacy; older adults

Outcome Measures

Primary Outcomes (18)

• 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)

• 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 to 12 months (T2)

• 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)

• 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)

Study Arms (4)

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.

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.

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.

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.

Device: Active aGeing And Personalised service's Ecosystem (AGAPE)

Interventions

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.

Tertiary end users; formal caregiver; informal caregiver; primary end-users

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi, Firenze

Florence, Italy

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: February 6, 2024
• Primary Completion: November 13, 2024
• Study Completion: March 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-02

Locations

IT (1)