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/NCT06004557</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A02818-35</org_study_id>
      <nct_id>NCT06004557</nct_id>
    </id_info>
    <brief_title>Validation of a Digital Multidimensional Assessment Tool for the Elderly in Geriatric Consultations</brief_title>
    <official_title>Validation d'un Outil numérique d'évaluation Multidimensionnelle Pour Les Personnes âgées Dans un Contexte de Consultations gériatriques</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RIVAGES</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RIVAGES</source>
    <oversight_info>
      <has_dmc>Yes</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 aim of this study is to validate a digital multidimensional assessment tool for elderly&#xD;
        people in geriatric consultations. The aim is to use a digital tablet to rapidly assess&#xD;
        several risks (loss of functional independence, risk of falling, risk of malnutrition, risk&#xD;
        of depression and risk of burden for the carer) in the context of hospital consultations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of digital tools on tablets to gather information from patients is on the increase.&#xD;
        Numerous computerised tools exist for identifying health problems and have been validated in&#xD;
        the medical world. However, there are currently no digital tools adapted to the elderly in a&#xD;
        consultation context. In this project, the investigators want to carry out a cross-sectional&#xD;
        observational study to assess the validity of a multidimensional assessment tool on a tablet,&#xD;
        self-administered by patients or carers, and also the appropriateness of using it with these&#xD;
        groups.&#xD;
  &#xD;
        Objectives Multidimensional assessment tools have the advantage of enabling several issues to&#xD;
        be addressed systematically. In this research, the investigators want to assess the validity&#xD;
        of a multidimensional assessment tool in digital format in a population of elderly people and&#xD;
        carers. To do this, the investigators intend to use scales that already exist and are usually&#xD;
        used in paper format: the ADL and IADL for dependency, the Mini MNA for nutrition, the&#xD;
        Cornell and GDS-15 for depression, the mini Zarit for estimating the burden on carers and the&#xD;
        Cetaf score and short FES-I for the risk of falling. These assessment tools have been adapted&#xD;
        to digital format and brought together to form a comprehensive multidimensional assessment&#xD;
        tool.&#xD;
  &#xD;
        The investigators' first objective was to assess the validity of this set of scales in&#xD;
        digital format compared with their original paper versions, but the investigators also want&#xD;
        to measure the acceptability of this assessment tool in a geriatric population and among&#xD;
        family carers. In addition, the investigators plan to assess the adaptability of this tool&#xD;
        and its compatibility in a geriatric consultation setting. Finally, the investigators want to&#xD;
        measure doctors' satisfaction with the collection of this information, as a time-saving tool&#xD;
        for these professionals.&#xD;
  &#xD;
        Methods Eighty patients and eighty carers will be included in this study, recruited from the&#xD;
        geriatric consultation service (outpatient geriatrics department) at Charles Foix Hospital.&#xD;
        These will be people aged over 65, and family carers if it is not possible to carry out the&#xD;
        test on a self-administered basis.&#xD;
  &#xD;
        To do this, the investigators are planning a quantitative study to compare the scores&#xD;
        obtained by the digital version of the test with the data described by the doctors in the&#xD;
        reports, and in particular the same scales systematically filled in by the medical&#xD;
        profession. In addition, the investigators want to analyse what users say and assess their&#xD;
        experience of practical issues (grip, legibility, impression of confidentiality when filling&#xD;
        in the form in the waiting room, etc.).&#xD;
  &#xD;
        Outlook A multi-theme self-questionnaire assessment of elderly people and their carers&#xD;
        waiting for a consultation would save professionals time (in terms of completion time and&#xD;
        calculation of results), make data more secure, save paper and provide a complete and&#xD;
        systematic scan of a number of potentially serious risks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Tests used to compare results between the digital version (tablet) and results from healthcare profession</measure>
      <time_frame>about 3 months</time_frame>
      <description>Calculation of the interclass correlation coefficient (ICC), a statistical method for estimating the equivalence of scores obtained from electronic versions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Method used to compare and visualise discrepancies between the results of the digital version (tablet) and the results of healthcare professionals</measure>
      <time_frame>about 3 months</time_frame>
      <description>Bland and Altman concordance method, graph showing the differences between the scores obtained by the two scales for each observation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Qualitative assessment</measure>
      <time_frame>about 3 months</time_frame>
      <description>Final questionnaire to evaluate user experimentation</description>
    </secondary_outcome>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Elderly People in a Consultation Context</condition>
    <eligibility>
      <study_pop>
        <textblock>
          We would like to offer this study to patients who come to us with memory problems, in&#xD;
          accordance with the inclusion criteria set out above. If they are unable to take part, and&#xD;
          if family carers are available, they will be able to fill in the questionnaire on a tablet.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People aged over 65 attending a geriatric consultation (if patient)&#xD;
  &#xD;
            -  Person agreeing to take part in the study and having signed the letter of consent (if&#xD;
               patient)&#xD;
  &#xD;
            -  Person caring for an elderly person (if family caregiver)&#xD;
  &#xD;
            -  Someone who visits their relative at least once a week (if family caregiver)&#xD;
  &#xD;
            -  Person agreeing to take part in the study and to complete the evaluation tool in paper&#xD;
               format and on a tablet for their relative (if family caregiver)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Incapacity to consent (if patient)&#xD;
  &#xD;
            -  Refusal to take part in the study (if patient)&#xD;
  &#xD;
            -  Person under legal protection (if patient)&#xD;
  &#xD;
            -  People in palliative care (if patient)&#xD;
  &#xD;
            -  Person who usually has little contact with the patient (if family caregiver)&#xD;
  &#xD;
            -  Refusal to take part in the study (if family caregiver)&#xD;
  &#xD;
            -  Incapacity to consent (if family caregiver)&#xD;
  &#xD;
            -  Person under legal protection (if family caregiver)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Joël Belmin, Professor</last_name>
      <phone>0033149594565</phone>
      <email>j.belmin@aphp.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université</name>
        <address>
          <city>Ivry-sur-Seine</city>
          <zip>94200</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joël Belmin</last_name>
        <phone>+33149594565</phone>
        <email>j.belmin@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Tablet</keyword>
    <keyword>multidimensional assessment</keyword>
    <keyword>geriatrics</keyword>
    <keyword>consultation</keyword>
    <keyword>Validation of a measurement tool</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/NCT06004557
  org study id: 2022-A02818-35
  nct id: NCT06004557
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to validate a digital multidimensional assessment tool for elderly
        people in geriatric consultations. The aim is to use a digital tablet to rapidly assess
        several risks (loss of functional independence, risk of falling, risk of malnutrition, risk
        of depression and risk of burden for the carer) in the context of hospital consultations.
  The use of digital tools on tablets to gather information from patients is on the increase.
        Numerous computerised tools exist for identifying health problems and have been validated in
        the medical world. However, there are currently no digital tools adapted to the elderly in a
        consultation context. In this project, the investigators want to carry out a cross-sectional
        observational study to assess the validity of a multidimensional assessment tool on a tablet,
        self-administered by patients or carers, and also the appropriateness of using it with these
        groups.
  
        Objectives Multidimensional assessment tools have the advantage of enabling several issues to
        be addressed systematically. In this research, the investigators want to assess the validity
        of a multidimensional assessment tool in digital format in a population of elderly people and
        carers. To do this, the investigators intend to use scales that already exist and are usually
        used in paper format: the ADL and IADL for dependency, the Mini MNA for nutrition, the
        Cornell and GDS-15 for depression, the mini Zarit for estimating the burden on carers and the
        Cetaf score and short FES-I for the risk of falling. These assessment tools have been adapted
        to digital format and brought together to form a comprehensive multidimensional assessment
        tool.
  
        The investigators' first objective was to assess the validity of this set of scales in
        digital format compared with their original paper versions, but the investigators also want
        to measure the acceptability of this assessment tool in a geriatric population and among
        family carers. In addition, the investigators plan to assess the adaptability of this tool
        and its compatibility in a geriatric consultation setting. Finally, the investigators want to
        measure doctors' satisfaction with the collection of this information, as a time-saving tool
        for these professionals.
  
        Methods Eighty patients and eighty carers will be included in this study, recruited from the
        geriatric consultation service (outpatient geriatrics department) at Charles Foix Hospital.
        These will be people aged over 65, and family carers if it is not possible to carry out the
        test on a self-administered basis.
  
        To do this, the investigators are planning a quantitative study to compare the scores
        obtained by the digital version of the test with the data described by the doctors in the
        reports, and in particular the same scales systematically filled in by the medical
        profession. In addition, the investigators want to analyse what users say and assess their
        experience of practical issues (grip, legibility, impression of confidentiality when filling
        in the form in the waiting room, etc.).
  
        Outlook A multi-theme self-questionnaire assessment of elderly people and their carers
        waiting for a consultation would save professionals time (in terms of completion time and
        calculation of results), make data more secure, save paper and provide a complete and
        systematic scan of a number of potentially serious risks.
  observational model: Other
  time perspective: Other
  measure: Tests used to compare results between the digital version (tablet) and results from healthcare profession
  time frame: about 3 months
  description: Calculation of the interclass correlation coefficient (ICC), a statistical method for estimating the equivalence of scores obtained from electronic versions.
  measure: Method used to compare and visualise discrepancies between the results of the digital version (tablet) and the results of healthcare professionals
  time frame: about 3 months
  description: Bland and Altman concordance method, graph showing the differences between the scores obtained by the two scales for each observation.
  measure: Qualitative assessment
  time frame: about 3 months
  description: Final questionnaire to evaluate user experimentation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joël Belmin, Professor
  phone: 0033149594565
  email: j.belmin@aphp.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor