Active — Not RecruitingNot Applicable

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

Italy68 participantsStarted 2024-02-06

Plain-language summary

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

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

System Usability Scale (SUS)

Timeframe: From the enrollment to the end of treatment at 12 months (T2)

System Usability Scale (SUS)

Timeframe: From the enrollment to 6 months (T1)

System Usability Scale (SUS)

Timeframe: From the enrollment to 1 month (T0)

Ad Hoc socio-demographic questionnaire

Timeframe: From the enrollment to 6 months (T1)

Ad Hoc socio-demographic questionnaire

Timeframe: From the enrollment to 12 months (T2)

Ad Hoc socio-demographic questionnaire

Timeframe: From the enrollment to 1 month (T0)

TechnoStress Questionnaire

Timeframe: From the enrollment to 12 months (T2)

Trial details

NCT IDNCT06859489

SponsorFondazione Don Carlo Gnocchi Onlus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-13

View on ClinicalTrials.gov More Older People trials

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

System Usability Scale (SUS)

Timeframe: From the enrollment to the end of treatment at 12 months (T2)

System Usability Scale (SUS)

Timeframe: From the enrollment to 6 months (T1)

System Usability Scale (SUS)

Timeframe: From the enrollment to 1 month (T0)

Ad Hoc socio-demographic questionnaire

Timeframe: From the enrollment to 6 months (T1)

Ad Hoc socio-demographic questionnaire

Timeframe: From the enrollment to 12 months (T2)

Ad Hoc socio-demographic questionnaire

Timeframe: From the enrollment to 1 month (T0)

TechnoStress Questionnaire

Timeframe: From the enrollment to 12 months (T2)