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

NCT05963399 | Not Yet Recruiting

• 1 other identifier: INRCA_007_2023
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 3

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. .

Conditions

Old Age

Keywords

ageing; older adults; artificial intelligence; informal caregiver; usability; acceptance; Intrinsic capacity; quality of life; wellbeing; loneliness; ICT-based solution

Outcome Measures

Primary Outcomes (2)

• Change in acceptability of the CAREUP platform

  Acceptability will be assess by an ad hoc structured questionnaire of 10 questions to collect data about like and dislike of the Careup platform.

  baseline and 12 months later

• Change in usability of the CAREUP platform

  The System Usability Scale (SUS) is a reliable tool for measuring usability. It consists of a10 item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'.

  baseline and 12 months later

Secondary Outcomes (3)

• Change in Physical Performance

  baseline, 6 and 12 months later

• Change in Quality of Life

  baseline, 6 and 12 months later

• Change in Mood

  baseline, 6 and 12 months later

Study Arms (1)

older adults

EXPERIMENTAL

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

Device: CAREUP platform

Interventions

CAREUP platform DEVICE

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

older adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• European Union: collaborator

Study Sites (3)

EURAG Austria

Vienna, Austria

Location

IRCCS INRCA Hospital

Ancona, 60127, Italy

Location

Ana Aslan International Foundation

Bucharest, Romania

Location

Study Officials

• Vera Stara

  IRCCS INRCA, Ancona, Italy

  STUDY CHAIR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

+390718003719; a.bonfigli@inrca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: April 30, 2024
• Primary Completion: December 14, 2024
• Study Completion: December 14, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

AU (1); IT (1); RO (1)