<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/NCT03834207</url>
  </required_header>
  <id_info>
    <org_study_id>689181</org_study_id>
    <nct_id>NCT03834207</nct_id>
  </id_info>
  <brief_title>A Study of the Usefulness &amp; Usability of a Healthcare IT System for Managing Multi-morbidity and Poly-pharmacy</brief_title>
  <acronym>C3-Cloud</acronym>
  <official_title>A Federated Collaborative Care Cure Cloud Architecture for Addressing the Needs of Multi-morbidity and Managing Poly-pharmacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Christopher Marguerie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Warwick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kronikgune</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medixine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SRDC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eurorec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Empirica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Osakidetza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region Jämtland Härjedalen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cambio Healthcare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>South Warwickshire NHS Foundation Trust</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>
      To assess the acceptability of a personalised ICT tool that facilitates coordinated care&#xD;
      planning, treatment optimisation and patient self-management for patients with multiple long&#xD;
      term conditions and their team of health professionals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      C3-CLOUD is a 4 year research project (information technology trial) funded by the EC to&#xD;
      develop, pilot &amp; evaluate a new clinical IT system to improve the management of elderly&#xD;
      patients with multi-morbidity &amp; poly-pharmacy. It will optimise patient education &amp;&#xD;
      self-management and foster closer collaborative working and shared decision making between&#xD;
      healthcare professionals &amp; patients using electronic multi-disciplinary care plans.&#xD;
&#xD;
      The main research question is - &quot;Is the use of a personalised ICT tool that facilitates&#xD;
      coordinated care planning, treatment optimisation and patient self-management acceptable to&#xD;
      patients with multiple long term conditions and their team of health professionals?&quot;.&#xD;
&#xD;
      The 1st phase has focused on the development &amp; testing of the system. The 2nd phase will&#xD;
      involve a 12 month pilot (Feb 17-Jan 18) with max 602 patients (+/- the support of their&#xD;
      informal care givers), and a minimum of 62 healthcare professionals in 3 European pilot sites&#xD;
      in the UK, Sweden &amp; Spain. An evaluation will be conducted using healthcare/treatment data &amp;&#xD;
      the completion of questionnaires by the study participants.&#xD;
&#xD;
      The C3-Cloud project structure is as follows:- Funded by the EC; Co-ordinated by Warwick&#xD;
      University; 12 European partners involved, supplying technical, clinical &amp; research&#xD;
      expertise. These partners are based in the UK, Spain, Sweden, France, Turkey, Finland &amp;&#xD;
      Germany; and 3 European pilot sites involved in the study - Basque Country in Spain, Region&#xD;
      Jamtland in Sweden and South Warwickshire in the UK.&#xD;
&#xD;
      The C3-CLOUD system consists of the following 2 integrated components. (i) C3DP - this&#xD;
      component will be used by healthcare professionals in all 3 pilot sites to manage the care of&#xD;
      the study patients. This system records e.g. patient identifiers, contact information,&#xD;
      diagnoses, medication, treatments, encounters, risk factors, goals &amp; activities for the&#xD;
      patients etc. It also provides professionals with a clinical decision support module. (ii) a&#xD;
      Patient Empowerment Platform (PEP) - used by patients (&amp; carers where applicable) so that&#xD;
      they can view &amp; update their care plan. Patients can record information about themselves,&#xD;
      their condition and their care, can view training materials &amp; upload readings such as blood&#xD;
      pressure etc. PEP also automatically takes information from the C3DP system above.&#xD;
&#xD;
      The study is aiming to recruit a minimum of 602 patients to the C3-CLOUD pilot study across&#xD;
      all 3 pilot sites. Informed consent to participate in the study will be obtained. The&#xD;
      patients must be aged 55+ and have at least 2 or more of the following chronic diseases -&#xD;
      diabetes type 2, mild to moderate heart failure, moderate kidney failure and mild to moderate&#xD;
      depression. They must also have a sufficiently high level of IT understanding and access to a&#xD;
      suitable device/the internet, or must nominate a carer, family member or friend who does.&#xD;
&#xD;
      The patients who are recruited will receive care and treatment using the C3-CLOUD system and&#xD;
      will have identifiable data collected about them by healthcare professionals in C3DP, and&#xD;
      will use, and provide information about themselves, in the PEP system.&#xD;
&#xD;
      A separate cohort of max 602 patients will be identified retrospectively from local health&#xD;
      records at the end of the study to create a 'control' group. These patients will match the&#xD;
      same inclusion criteria. However, this control group will have no active role in the study&#xD;
      and only their anonymised data will be utilised so that resource utilisation, medication use&#xD;
      etc, can be compared for the two groups over the same period.&#xD;
&#xD;
      In the UK, the system will be used by a cross-section of healthcare professionals (minimum&#xD;
      62) across the 3 pilot sites. These will be the healthcare professionals who are most likely&#xD;
      to be involved ordinarily in treating the patients during the study.&#xD;
&#xD;
      In addition to the clinical data captured above, the intervention group patients, their&#xD;
      carers and the healthcare professionals involved in the project will participate in a series&#xD;
      of system/project evaluations before, during and after the study. This will be done through&#xD;
      anonymised questionnaires.&#xD;
&#xD;
      Healthcare utilisation &amp; outcome data will be collected about intervention AND control group&#xD;
      patients from local health records systems in an anonymised format. Evaluation data for the&#xD;
      intervention group patients will also be extracted from the C3-Cloud system itself in an&#xD;
      anonymised format.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</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>
    <intervention_model_description>A single intervention group that will use and evaluate the C3-Cloud system during the 12 month study. Please note that an anonymous group of patients meeting the same criteria will be identified retrospectively at the end of the study so that healthcare resource utilisation during the same period can be compared.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability &amp; usefulness of the C3-Cloud system</measure>
    <time_frame>12 months</time_frame>
    <description>This is qualitative research so the primary outcome measure will be the acceptability and usefulness of the technology by patients, informal care givers and health &amp; care professionals. The UTAUT questionnaire (Unified Theory of Acceptance and User of Technology) will be performed to determine C3-Cloud user responses along the following UTAUT categories: performance expectancy, effort expectancy, social influence, cultural and language factors, technology anxiety, adoption timeline and associated facilitating conditions on the intended adoption behaviour. The questionnaire will be performed online and data will be aggregated completely anonymously using the online questionnaire platform &quot;LimeSurvey&quot;, hosted on servers of empirica. The ordinal responses (e.g. &quot;I strongly disagree&quot; or &quot;I strongly agree&quot;) are clustered along the UTAUT categories analsed anonymously.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">672</enrollment>
  <condition>Diabetes Type 2</condition>
  <condition>Renal Failure</condition>
  <condition>Heart Failure</condition>
  <condition>Depression</condition>
  <condition>Chronic Disease</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the C3-Cloud IT system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of the C3-Cloud IT system</intervention_name>
    <description>Patients who are recruited to the intervention arm will use the C3-Cloud system during the pilot study.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PATIENTS - Inclusion Criteria:-&#xD;
&#xD;
          -  They are aged 55 or older&#xD;
&#xD;
          -  They are multimorbid patients that suffer from two or more of the following four&#xD;
             conditions in various disease combinations (two conditions set as the minimum&#xD;
             threshold):-&#xD;
&#xD;
          -  Diabetes type 2&#xD;
&#xD;
          -  Renal Failure with eGFR/GFR 30 - 59 (measured or estimated glomerular filtration rate)&#xD;
&#xD;
          -  Heart Failure in compliance with NYHA I-II (New York Heart Association classification&#xD;
             of heart failure)&#xD;
&#xD;
          -  Mild or moderate depression&#xD;
&#xD;
          -  They still live and generally plan on living in their home (or in the community) for&#xD;
             the 12-month trial duration.&#xD;
&#xD;
          -  They or their informal caregiver pass the ICT Handling Self-Check (see Deliverable&#xD;
             D10.4, Annex 8.3) (i.e. they have access to and some familiarity with the use of ICT).&#xD;
&#xD;
          -  They, or their informal caregiver, have stable access to the internet and at least one&#xD;
             of the following devices readily available to use the C3-Cloud components: Computer;&#xD;
             Notebook; Smartphone; Tablet. This includes the use of Internet Browsers to open the&#xD;
             C3-Cloud patient dashboards online.&#xD;
&#xD;
          -  They are able to provide informed consent.&#xD;
&#xD;
        PATIENTS - Exclusion Criteria:-&#xD;
&#xD;
        •The exclusion criteria include almost completely the reverse of the inclusion criteria.&#xD;
        Patients are not eligible for recruitment if:-&#xD;
&#xD;
          -  They are aged 54 or below&#xD;
&#xD;
          -  They suffer from any of the following conditions:&#xD;
&#xD;
          -  Severe Renal Failure with eGFR/GFR &lt;30&#xD;
&#xD;
          -  Severe Heart Failure in compliance with NYHA III-IV&#xD;
&#xD;
          -  Severe depression&#xD;
&#xD;
          -  They have other debilitating conditions that impair their decision making capability&#xD;
             or their life expectancy (e.g. end-of-life patients or cancer patients)&#xD;
&#xD;
          -  They or their informal caregivers do not pass the ICT Handling Self-Check (i.e. they&#xD;
             do not have access to suitable IT devices and do not have some familiarity with the&#xD;
             use of ICT).&#xD;
&#xD;
          -  They have disabilities or other health conditions that would prevent their active&#xD;
             involvement in the study project or which prevent them from carrying out essential&#xD;
             functions of the trial.&#xD;
&#xD;
          -  They live in a care institution, for instance in a residential home or nursing home.&#xD;
&#xD;
          -  Their health care expenses are covered by a private insurance: in the C3-Cloud pilot&#xD;
             sites, private insurances have no data exchange with EHRs.&#xD;
&#xD;
          -  They do not speak the regional language: English for SWFT; Spanish for the Basque&#xD;
             country; Swedish for RJH&#xD;
&#xD;
          -  They are unable to provide informed consent for study participation.&#xD;
&#xD;
        Patients with further chronic diseases and other co-morbidities or symptoms, for example,&#xD;
        frailty, sleeping problems, malnourishment or anxiety, will not be excluded from&#xD;
        recruitment. Informal caregivers who pass the ICT Handling Self-Check can substitute for&#xD;
        the patient if the patient does not pass the ICT Handling Self-Check - the patient-informal&#xD;
        caregiver pair can then still be recruited.&#xD;
&#xD;
        PATIENT'S HELPERS/CARERS - Exclusion Criteria:-&#xD;
&#xD;
        There are no specific inclusion criteria for informal caregivers. However, the following&#xD;
        exclusion criteria apply:-&#xD;
&#xD;
          -  They are aged 17 or below&#xD;
&#xD;
          -  They do not have some familiarity with the use of ICT or do not have the capability to&#xD;
             help the patient out with ICT usage if necessary.&#xD;
&#xD;
          -  They do not have stable access to the internet and at least one of the following&#xD;
             devices readily available to use the C3-Cloud components: Computer; Notebook;&#xD;
             Smartphone; Tablet. This includes the use of Internet Browsers to open the C3-Cloud&#xD;
             patient dashboards online.&#xD;
&#xD;
          -  They are not available most of the time in person or via telephone, email, SMS or&#xD;
             other means as to respond to calls for help.&#xD;
&#xD;
          -  They have debilitating conditions that impair their decision-making capability.&#xD;
&#xD;
          -  They do not speak the local language: English for SWFT; Spanish for the Basque&#xD;
             country; Swedish for RJH&#xD;
&#xD;
        HEALTHCARE PROFESSIONALS - Inclusion Criteria:-&#xD;
&#xD;
          -  normally be involved in the selected patients care&#xD;
&#xD;
          -  open to new ways of working, specifically as part of a MDT (including GPs; consultant&#xD;
             nurses or specialist nurses; district nurses; social workers; consultants;&#xD;
             physiotherapists or pharmacists)&#xD;
&#xD;
          -  open to the use of new technology: MDT members do not have to be technologically&#xD;
             knowledgeable but they should be willing to learn how to use technology to support&#xD;
             their work.&#xD;
&#xD;
        HEALTHCARE PROFESSIONALS - Exclusion Criteria:-&#xD;
&#xD;
          -  None specific. Reverse of the above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theodoros N. Arvanitis</last_name>
    <role>Study Chair</role>
    <affiliation>University of Warwick</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Theodoros N. Arvanitis</last_name>
    <phone>+44 (0)24 7615 1601</phone>
    <email>T.Arvanitis@warwick.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Lim Choi Keung</last_name>
    <phone>+44 (0)247 657 3776</phone>
    <email>S.N.Lim-Choi-Keung@warwick.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Osakidetza</name>
      <address>
        <city>Vitoria-Gasteiz</city>
        <state>Araba</state>
        <zip>01006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dolores Verdoy, PhD</last_name>
      <phone>944007797</phone>
      <email>dverdoy@kronikgune.org</email>
    </contact>
    <contact_backup>
      <last_name>Ane Fullaondo, PhD</last_name>
      <phone>+34 944007792</phone>
      <email>afullaondo@kronikgune.org</email>
    </contact_backup>
    <investigator>
      <last_name>Antonio de Blas</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas Gonzalez</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Javier Urraca</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rafael Rotaeche</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Esteban de Manuel</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ane Fullaondo</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amaia Saenz de Ormijana</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Remedios Vega</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Region Jamtland Harjedalen</name>
      <address>
        <city>Ostersund</city>
        <zip>S-831 27</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mikael Lilja, Md, PhD</last_name>
      <phone>+4663(0)153005</phone>
      <email>mikael.lilja@regionjh.se</email>
    </contact>
    <contact_backup>
      <last_name>Anna Eriksson, RN</last_name>
      <phone>+46(0)702426192</phone>
      <email>anna.eriksson@regionjh.se</email>
    </contact_backup>
    <investigator>
      <last_name>Anna Eriksson, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mikael Lilja, Md, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>South Warwickshire NHS Foundation Trust</name>
      <address>
        <city>Warwick</city>
        <state>Warwickshire</state>
        <zip>CV34 5BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christopher Marguerie, Medicine</last_name>
      <phone>01926 495321</phone>
      <phone_ext>4414</phone_ext>
      <email>Christopher.Marguerie@swft.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Marie Beach, History</last_name>
      <phone>01926 600853</phone>
      <phone_ext>3085</phone_ext>
      <email>marie.beach@swft.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Christopher Marguerie, Medicine</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christina Ramos, Medicine</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.c3-cloud.eu/</url>
    <description>C3-Cloud Website</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>South Warwickshire NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Dr Christopher Marguerie</investigator_full_name>
    <investigator_title>Consultant Rheumatologist/Associate Medical Director for Research</investigator_title>
  </responsible_party>
  <keyword>C3-Cloud</keyword>
  <keyword>Multimorbidity</keyword>
  <keyword>Diabetes Type 2</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Cardiac Failure</keyword>
  <keyword>Depression</keyword>
  <keyword>Renal Failure</keyword>
  <keyword>Kidney Failure</keyword>
  <keyword>Ageing</keyword>
  <keyword>Computer System</keyword>
  <keyword>Information Technology</keyword>
  <keyword>Patient Empowerment</keyword>
  <keyword>Guideline Reconciliation</keyword>
  <keyword>Polypharmacy</keyword>
  <keyword>Integrated Care</keyword>
  <keyword>Clinical Decision Support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only anonymised, aggregated data will be shared with researchers.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>June 22, 2021</submitted>
    <returned>July 13, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03834207
org study id: 689181
nct id: NCT03834207
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the acceptability of a personalised ICT tool that facilitates coordinated care
      planning, treatment optimisation and patient self-management for patients with multiple long
      term conditions and their team of health professionals.
C3-CLOUD is a 4 year research project (information technology trial) funded by the EC to
      develop, pilot & evaluate a new clinical IT system to improve the management of elderly
      patients with multi-morbidity & poly-pharmacy. It will optimise patient education &
      self-management and foster closer collaborative working and shared decision making between
      healthcare professionals & patients using electronic multi-disciplinary care plans.

      The main research question is - "Is the use of a personalised ICT tool that facilitates
      coordinated care planning, treatment optimisation and patient self-management acceptable to
      patients with multiple long term conditions and their team of health professionals?".

      The 1st phase has focused on the development & testing of the system. The 2nd phase will
      involve a 12 month pilot (Feb 17-Jan 18) with max 602 patients (+/- the support of their
      informal care givers), and a minimum of 62 healthcare professionals in 3 European pilot sites
      in the UK, Sweden & Spain. An evaluation will be conducted using healthcare/treatment data &
      the completion of questionnaires by the study participants.

      The C3-Cloud project structure is as follows:- Funded by the EC; Co-ordinated by Warwick
      University; 12 European partners involved, supplying technical, clinical & research
      expertise. These partners are based in the UK, Spain, Sweden, France, Turkey, Finland &
      Germany; and 3 European pilot sites involved in the study - Basque Country in Spain, Region
      Jamtland in Sweden and South Warwickshire in the UK.

      The C3-CLOUD system consists of the following 2 integrated components. (i) C3DP - this
      component will be used by healthcare professionals in all 3 pilot sites to manage the care of
      the study patients. This system records e.g. patient identifiers, contact information,
      diagnoses, medication, treatments, encounters, risk factors, goals & activities for the
      patients etc. It also provides professionals with a clinical decision support module. (ii) a
      Patient Empowerment Platform (PEP) - used by patients (& carers where applicable) so that
      they can view & update their care plan. Patients can record information about themselves,
      their condition and their care, can view training materials & upload readings such as blood
      pressure etc. PEP also automatically takes information from the C3DP system above.

      The study is aiming to recruit a minimum of 602 patients to the C3-CLOUD pilot study across
      all 3 pilot sites. Informed consent to participate in the study will be obtained. The
      patients must be aged 55+ and have at least 2 or more of the following chronic diseases -
      diabetes type 2, mild to moderate heart failure, moderate kidney failure and mild to moderate
      depression. They must also have a sufficiently high level of IT understanding and access to a
      suitable device/the internet, or must nominate a carer, family member or friend who does.

      The patients who are recruited will receive care and treatment using the C3-CLOUD system and
      will have identifiable data collected about them by healthcare professionals in C3DP, and
      will use, and provide information about themselves, in the PEP system.

      A separate cohort of max 602 patients will be identified retrospectively from local health
      records at the end of the study to create a 'control' group. These patients will match the
      same inclusion criteria. However, this control group will have no active role in the study
      and only their anonymised data will be utilised so that resource utilisation, medication use
      etc, can be compared for the two groups over the same period.

      In the UK, the system will be used by a cross-section of healthcare professionals (minimum
      62) across the 3 pilot sites. These will be the healthcare professionals who are most likely
      to be involved ordinarily in treating the patients during the study.

      In addition to the clinical data captured above, the intervention group patients, their
      carers and the healthcare professionals involved in the project will participate in a series
      of system/project evaluations before, during and after the study. This will be done through
      anonymised questionnaires.

      Healthcare utilisation & outcome data will be collected about intervention AND control group
      patients from local health records systems in an anonymised format. Evaluation data for the
      intervention group patients will also be extracted from the C3-Cloud system itself in an
      anonymised format.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single intervention group that will use and evaluate the C3-Cloud system during the 12 month study. Please note that an anonymous group of patients meeting the same criteria will be identified retrospectively at the end of the study so that healthcare resource utilisation during the same period can be compared.
primary purpose: Other
masking: None (Open Label)
measure: Acceptability & usefulness of the C3-Cloud system
time frame: 12 months
description: This is qualitative research so the primary outcome measure will be the acceptability and usefulness of the technology by patients, informal care givers and health & care professionals. The UTAUT questionnaire (Unified Theory of Acceptance and User of Technology) will be performed to determine C3-Cloud user responses along the following UTAUT categories: performance expectancy, effort expectancy, social influence, cultural and language factors, technology anxiety, adoption timeline and associated facilitating conditions on the intended adoption behaviour. The questionnaire will be performed online and data will be aggregated completely anonymously using the online questionnaire platform "LimeSurvey", hosted on servers of empirica. The ordinal responses (e.g. "I strongly disagree" or "I strongly agree") are clustered along the UTAUT categories analsed anonymously.
arm group label: Intervention Group
arm group type: Experimental
description: Use of the C3-Cloud IT system
intervention type: Device
intervention name: Use of the C3-Cloud IT system
description: Patients who are recruited to the intervention arm will use the C3-Cloud system during the pilot study.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Theodoros N. Arvanitis
role: Study Chair
affiliation: University of Warwick
last name: Theodoros N. Arvanitis
phone: +44 (0)24 7615 1601
email: T.Arvanitis@warwick.ac.uk
last name: Sarah Lim Choi Keung
phone: +44 (0)247 657 3776
email: S.N.Lim-Choi-Keung@warwick.ac.uk
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
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investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
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investigator: 
investigator: 
country: Spain
country: Sweden
country: United Kingdom
url: http://www.c3-cloud.eu/
description: C3-Cloud Website
responsible party type: Sponsor-Investigator
investigator affiliation: South Warwickshire NHS Foundation Trust
investigator full name: Dr Christopher Marguerie
investigator title: Consultant Rheumatologist/Associate Medical Director for Research
mesh term: Renal Insufficiency
mesh term: Heart Failure
mesh term: Diabetes Mellitus, Type 2
mesh term: Chronic Disease
mesh term: Depression
sharing ipd: No
ipd description: Only anonymised, aggregated data will be shared with researchers.
submitted: June 22, 2021
returned: July 13, 2021