Old AgeCAREUPNCT05963399
An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)
A study testing CAREUP platform in people with Old Age, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age
- What is being tested?
- CAREUP platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 30 Apr 2024to 14 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Italy1 site
IRCCS INRCA Hospital
Ancona, 60127
Vera Stara, v.stara@inrca.it
Elisa Felici
About this study
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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Read the 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
- Being tested
- CAREUP platform
- Keywords
- ageing, older adults, artificial intelligence, informal caregiver, usability, acceptance, Intrinsic capacity, quality of life, wellbeing, loneliness, ICT-based solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREUP platformDevice
The Experimental Group will test the CAREUP platform at home for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| older adults | Experimental | Elderly adults who live independently in their own home in rural or urban areas. Receives: Device: CAREUP platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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'.
Measured: baseline and 12 months later
Secondary outcomes (3)
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.
Measured: baseline, 6 and 12 months later
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'.
Measured: baseline, 6 and 12 months later
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.
Measured: baseline, 6 and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start30 Apr 2024 (estimated)
- Primary completion14 Dec 2024 (estimated)
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Vera Stara, Study chair, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963399
- Sponsor's protocol ID
- INRCA_007_2023
- Acronym
- CAREUP
- Status last verified
- Mar 2024
- First submitted
- 17 Jul 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)
- ClinicalTrials.gov ID
- NCT05963399
- Acronym / sponsor ID
- CAREUP / INRCA_007_2023
- Conditions
- Old Age
- Keywords
- ageing, older adults, artificial intelligence, informal caregiver, usability, acceptance, Intrinsic capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 14 Dec 2024 (estimated)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older adults | Experimental | Device: CAREUP platformElderly adults who live independently in their own home in rural or urban areas. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAREUP platformThe Experimental Group will test the CAREUP platform at home for 12 months. | Device | older adults |
Primary outcome
Change in acceptability of the CAREUP platform
Time frame: baseline and 12 months later
Acceptability will be assess by an ad hoc structured questionnaire of 10 questions to collect data about like and dislike of the Careup platform.
Change in usability of the CAREUP platform
Time frame: baseline and 12 months later
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'.
3 secondary outcomes
Change in Physical Performance
Time frame: baseline, 6 and 12 months later
Change in Quality of Life
Time frame: baseline, 6 and 12 months later
Change in Mood
Time frame: baseline, 6 and 12 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Stara study chair
IRCCS INRCA, Ancona, Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAREUP platform in people with Old Age, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Italy, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli (+390718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acceptability of the CAREUP platform (time frame: baseline and 12 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.