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CAREUPAn Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)

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What is being tested

CAREUP platform

Device
Who is being recruted

Over 65 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorIstituto Nazionale di Ricovero e Cura per Anziani
Study ContactAnna Rita Bonfigli
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 30, 2024

Actual date on which the first participant was enrolled.

The objective of this study is to assess the usability and acceptance of the CAREUP solution at home in primary (older adults), secondary (informal caregivers) and tertiary (doctors and geriatrics) end users. The CAREUP solution is a platform that collects data from different tools such as tablets, smartwatches, ambient sensors, iHealth weight scale, and Digital Hand Dynamometer. The study will comprehends two phases: a pre-pilot and pilot phases.The pre-pilot phase will test new user interfaces and games with 5 older adult (primary users) and 5 informal caregiver (secondary) in each site (Italy, Romania, Austria) for at least 1 week. This phase will only focus on primary endpoints (usability and acceptance). The pilot phase will investigate platform usability, acceptance and efficiency of developed Intrinsic Capacity (IC) evaluation algorithms, reliability and security. At least 30 primary and 15 secondary and some tertiary users (doctors and geriatrics) will be enrolled in each country (Italy, Romania, Austria) for 12 months. This phase will focus on both primary and secondary endpoints.

Official TitleAn Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)
NCT05963399
Principal SponsorIstituto Nazionale di Ricovero e Cura per Anziani
Study ContactAnna Rita Bonfigli
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Live independently in their home in rural or urban areas;
In good physical and cognitive status;
Able to stand and walk unaided;
Availability to sign the Informed Consent;
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12 exclusion criteria prevent from participating
Use of active implant or not-implant medical devices;
Allergy to nickel components;
Lack of written informed consent;
Acute or untreated medical problems such as history of syncopal episodes, epilepsy and vertigo not controlled pharmacologically; serious dysfunction of the autonomic system; severe behavioural syndromes not compensated by drugs; concurrent neurological diseases; severe systemic diseases with life expectancy < 1 year;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Elderly adults who live independently in their own home in rural or urban areas.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

EURAG Austria

Vienna, AustriaOpen EURAG Austria in Google Maps
Suspended

IRCCS INRCA Hospital

Ancona, Italy
Suspended

Ana Aslan International Foundation

Bucharest, Romania
Recruiting soon3 Study Centers