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

March 4, 2024 updated by: Istituto Nazionale di Ricovero e Cura per Anziani

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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Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria
        • EURAG Austria
        • Contact:
          • Eva Reither
        • Principal Investigator:
          • Eva Reither
  • Italy
      • Ancona, Italy, 60127
        • IRCCS INRCA Hospital
        • Principal Investigator:
          • Elisa Felici
        • Contact:
  • Romania
      • Bucharest, Romania
        • Ana Aslan International Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: older adults
Elderly adults who live independently in their own home in rural or urban areas.
Device: CAREUP platform
The Experimental Group will test the CAREUP platform at home for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 12 months later
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'.
baseline and 12 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Performance
Time Frame: baseline, 6 and 12 months later
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
Change in Quality of Life
Time Frame: baseline, 6 and 12 months later
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
Change in Mood
Time Frame: baseline, 6 and 12 months later
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Collaborators

European Union

Investigators

  • Study Chair: Vera Stara, IRCCS INRCA, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

December 14, 2024

Study Completion (Estimated)

December 14, 2024

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INRCA_007_2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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