Clinical trial NCT05963399: An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)
Official title: An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Old Age
Keywords: ageing
older adults
artificial intelligence
informal caregiver
usability
acceptance
Intrinsic capacity
quality of life
wellbeing
loneliness
ICT-based solution
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2023-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in acceptability of the CAREUP platform
timeFrame: baseline and 12 months later
measure: Change in usability of the CAREUP platform
timeFrame: baseline and 12 months later
Secondary outcomes:
measure: Change in Physical Performance
timeFrame: baseline, 6 and 12 months later
measure: Change in Quality of Life
timeFrame: baseline, 6 and 12 months later
measure: Change in Mood
timeFrame: baseline, 6 and 12 months later
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: EURAG Austria
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Bucharest
country: Romania
facility: Ana Aslan International Foundation
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Vera Stara
role: STUDY_CHAIR
References: