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

Old Age Clinical Trial

— CAREUP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05963399
• Other study ID #: INRCA_007_2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: December 14, 2024

Study information

• Verified date: March 2024
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Anna Rita Bonfigli
• Phone: +390718003719
• Email: a.bonfigli[@]inrca.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 14, 2024
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Old Age

Intervention

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

Locations

Country	Name	City	State
Austria	EURAG Austria	Vienna
Italy	IRCCS INRCA Hospital	Ancona
Romania	Ana Aslan International Foundation	Bucharest

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani	European Union

Countries where clinical trial is conducted

Austria,  Italy,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Physical Performance	Short Physical Performance Battery (SPPB) is a short battery of tests designed to assess the function of the lower limbs. This scale consists of 3 different sections: balance assessment, evaluation of walking on 4 linear meters, evaluation of the ability to perform, for 5 consecutive times, the sit to stand from a chair, without using the upper limbs. The total scale score therefore has a range from 0 to 12. A total score below 10 indicates frailty and a high risk of disability and falls. The 1-point change in score from pre to post test is of clinical relevance.	baseline, 6 and 12 months later
Secondary	Change in Quality of Life	The EuroQol-5D-5L (EQ-5D-5L) scale consists of five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health status by ticking the box corresponding to the most appropriate statement in each of the five dimensions. The numbers from the five dimensions can be combined into a 5-digit number that describes the health status of the participant. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score. In addition, there is the EQ Visual Analogue scale (EQ VAS).The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The EQ-5D-5L now asks respondents to simply 'mark an X on the scale to indicate how your health is TODAY'.	baseline, 6 and 12 months later
Secondary	Change in Mood	The 15-item Geriatric Depression Scale (GDS-15) assesses the current condition of the patient's mood. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.	baseline, 6 and 12 months later