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NCT Number: 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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Older People Behavior Digital Health Literacy Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Carlo Gnocchi, Firenze

Florence, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Be-Com
  • Caritas Diocesana de Coimbra
  • Carol Davila University of Medicine and Pharmacy
  • MEDEA SRL
  • SenLab d.o.o.
  • Umana Persone

Registry information

Official study title

Active aGeing And Personalised Service's Ecosystem

Acronym: AGAPE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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