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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Not yet enrolling

Conditions

Old Age

Treatments

Device: CAREUP platform

Study type

Interventional

Funder types

Other

Identifiers

NCT05963399

INRCA_007_2023

Details and patient eligibility

About

The objective of this study is to assess the usability and acceptance of the CAREUP solution in improving the quality of life at home of the older adults. 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.

Full description

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.

Enrollment

90 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;
Ability to use smartphones/tablets independently.

Exclusion criteria

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;
A myocardial infarction or stroke within 6 months;
Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
Uncontrolled hypertension;
Pacemaker or implantable cardioverter defibrillator;
Diagnosis of mild and or/advanced Parkinson's disease or other neuromuscular disorder;
Diagnosis of mild and/or advance cognitive impairments
Metastatic cancer or immunosuppressive therapy;
Significant visual or hearing impairment