xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05963399</url>
    </required_header>
    <id_info>
      <org_study_id>INRCA_007_2023</org_study_id>
      <nct_id>NCT05963399</nct_id>
    </id_info>
    <brief_title>An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)</brief_title>
    <acronym>CAREUP</acronym>
    <official_title>An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto Nazionale di Ricovero e Cura per Anziani</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>European Union</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Istituto Nazionale di Ricovero e Cura per Anziani</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to assess the usability and acceptance of the CAREUP solution&#xD;
        in improving the quality of life at home of the older adults. The CAREUP solution is a&#xD;
        platform that collects data from different tools such as tablets, smartwatches, ambient&#xD;
        sensors, iHealth weight scale, and Digital Hand Dynamometer.&#xD;
  &#xD;
        .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this study is to assess the usability and acceptance of the CAREUP solution&#xD;
        at home in primary (older adults), secondary (informal caregivers) and tertiary (doctors and&#xD;
        geriatrics) end users. The CAREUP solution is a platform that collects data from different&#xD;
        tools such as tablets, smartwatches, ambient sensors, iHealth weight scale, and Digital Hand&#xD;
        Dynamometer. The study will comprehends two phases: a pre-pilot and pilot phases.The&#xD;
        pre-pilot phase will test new user interfaces and games with 5 older adult (primary users)&#xD;
        and 5 informal caregiver (secondary) in each site (Italy, Romania, Austria) for at least 1&#xD;
        week. This phase will only focus on primary endpoints (usability and acceptance). The pilot&#xD;
        phase will investigate platform usability, acceptance and efficiency of developed Intrinsic&#xD;
        Capacity (IC) evaluation algorithms, reliability and security. At least 30 primary and 15&#xD;
        secondary and some tertiary users (doctors and geriatrics) will be enrolled in each country&#xD;
        (Italy, Romania, Austria) for 12 months. This phase will focus on both primary and secondary&#xD;
        endpoints.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">December 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 14, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in acceptability of the CAREUP platform</measure>
      <time_frame>baseline and 12 months later</time_frame>
      <description>Acceptability will be assess by an ad hoc structured questionnaire of 10 questions to collect data about like and dislike of the Careup platform.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in usability of the CAREUP platform</measure>
      <time_frame>baseline and 12 months later</time_frame>
      <description>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'.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Physical Performance</measure>
      <time_frame>baseline, 6 and 12 months later</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life</measure>
      <time_frame>baseline, 6 and 12 months later</time_frame>
      <description>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'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Mood</measure>
      <time_frame>baseline, 6 and 12 months later</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Old Age</condition>
    <arm_group>
      <arm_group_label>older adults</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Elderly adults who live independently in their own home in rural or urban areas.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CAREUP platform</intervention_name>
      <description>The Experimental Group will test the CAREUP platform at home for 12 months.</description>
      <arm_group_label>older adults</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Live independently in their home in rural or urban areas;&#xD;
  &#xD;
            -  In good physical and cognitive status;&#xD;
  &#xD;
            -  Able to stand and walk unaided;&#xD;
  &#xD;
            -  Availability to sign the Informed Consent;&#xD;
  &#xD;
            -  Ability to use smartphones/tablets independently.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of active implant or not-implant medical devices;&#xD;
  &#xD;
            -  Allergy to nickel components;&#xD;
  &#xD;
            -  Lack of written informed consent;&#xD;
  &#xD;
            -  Acute or untreated medical problems such as history of syncopal episodes, epilepsy and&#xD;
               vertigo not controlled pharmacologically; serious dysfunction of the autonomic system;&#xD;
               severe behavioural syndromes not compensated by drugs; concurrent neurological&#xD;
               diseases; severe systemic diseases with life expectancy &lt; 1 year;&#xD;
  &#xD;
            -  A myocardial infarction or stroke within 6 months;&#xD;
  &#xD;
            -  Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy&#xD;
               limiting balance and mobility;&#xD;
  &#xD;
            -  Uncontrolled hypertension;&#xD;
  &#xD;
            -  Pacemaker or implantable cardioverter defibrillator;&#xD;
  &#xD;
            -  Diagnosis of mild and or/advanced Parkinson's disease or other neuromuscular disorder;&#xD;
  &#xD;
            -  Diagnosis of mild and/or advance cognitive impairments&#xD;
  &#xD;
            -  Metastatic cancer or immunosuppressive therapy;&#xD;
  &#xD;
            -  Significant visual or hearing impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vera Stara</last_name>
      <role>Study Chair</role>
      <affiliation>IRCCS INRCA, Ancona, Italy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anna Rita Bonfigli</last_name>
      <phone>+390718003719</phone>
      <email>a.bonfigli@inrca.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>EURAG Austria</name>
        <address>
          <city>Vienna</city>
          <country>Austria</country>
        </address>
      </facility>
      <contact>
        <last_name>Eva Reither</last_name>
      </contact>
      <investigator>
        <last_name>Eva Reither</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>IRCCS INRCA Hospital</name>
        <address>
          <city>Ancona</city>
          <zip>60127</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Vera Stara</last_name>
        <email>v.stara@inrca.it</email>
      </contact>
      <investigator>
        <last_name>Elisa Felici</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ana Aslan International Foundation</name>
        <address>
          <city>Bucharest</city>
          <country>Romania</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Austria</country>
      <country>Italy</country>
      <country>Romania</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ageing</keyword>
    <keyword>older adults</keyword>
    <keyword>artificial intelligence</keyword>
    <keyword>informal caregiver</keyword>
    <keyword>usability</keyword>
    <keyword>acceptance</keyword>
    <keyword>Intrinsic capacity</keyword>
    <keyword>quality of life</keyword>
    <keyword>wellbeing</keyword>
    <keyword>loneliness</keyword>
    <keyword>ICT-based solution</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05963399
  org study id: INRCA_007_2023
  nct id: NCT05963399
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  
        .
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in acceptability of the CAREUP platform
  time frame: baseline and 12 months later
  description: Acceptability will be assess by an ad hoc structured questionnaire of 10 questions to collect data about like and dislike of the Careup platform.
  measure: Change in usability of the CAREUP platform
  time frame: baseline and 12 months later
  description: 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'.
  measure: Change in Physical Performance
  time frame: baseline, 6 and 12 months later
  description: 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.
  measure: Change in Quality of Life
  time frame: baseline, 6 and 12 months later
  description: 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'.
  measure: Change in Mood
  time frame: baseline, 6 and 12 months later
  description: 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.
  arm group label: older adults
  arm group type: Experimental
  description: Elderly adults who live independently in their own home in rural or urban areas.
  intervention type: Device
  intervention name: CAREUP platform
  description: The Experimental Group will test the CAREUP platform at home for 12 months.
  arm group label: older adults
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vera Stara
  role: Study Chair
  affiliation: IRCCS INRCA, Ancona, Italy
  last name: Anna Rita Bonfigli
  phone: +390718003719
  email: a.bonfigli@inrca.it
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  country: Austria
  country: Italy
  country: Romania
  responsible party type: Sponsor