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

NCT ID: NCT05963399

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-12-14

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.

Conditions

Old Age

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

older adults

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

Group Type: EXPERIMENTAL

CAREUP platform

Intervention Type: DEVICE

The Experimental Group will test the CAREUP platform at home for 12 months.

Interventions

CAREUP platform

The Experimental Group will test the CAREUP platform at home for 12 months.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vera Stara

Role: STUDY_CHAIR

IRCCS INRCA, Ancona, Italy

Locations

EURAG Austria

Vienna, , Austria

IRCCS INRCA Hospital

Ancona, , Italy

Ana Aslan International Foundation

Bucharest, , Romania

Countries

Austria; Italy; Romania

Central Contacts

Anna Rita Bonfigli

Role: CONTACT

a.bonfigli@inrca.it

+390718003719

Facility Contacts

Eva Reither

Role: primary

Vera Stara

Role: primary

v.stara@inrca.it

Other Identifiers

INRCA_007_2023

Identifier Type: -

Identifier Source: org_study_id