<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/NCT03042039</url>
  </required_header>
  <id_info>
    <org_study_id>CareWell_EC_Grant No. 620983</org_study_id>
    <nct_id>NCT03042039</nct_id>
  </id_info>
  <brief_title>Multi-level Integration for Patients With Complex Needs Facilitated by ICTs. A Shared Approach, Mutual Learning and Evaluation Are Expected to Create Synergies Among the Partners and to Bring Forward Integration of Care in Europe</brief_title>
  <acronym>CAREWELL</acronym>
  <official_title>CareWell - Multi-level Integration for Patients With Complex Needs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Him SA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Him SA</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>
      CareWell will enable the delivery of integrated healthcare to frail elderly patients in a&#xD;
      pilot setting through comprehensive multidisciplinary integrated care programmes where the&#xD;
      role of ICTs can foster the coordination and patient centered delivery care. Carewell will&#xD;
      focus in particular complex, multi-morbid elderly patients, who the patients most in need of&#xD;
      health and social care resources (35% the total cost of Health Care System) and more complex&#xD;
      interventions due to their frailty and comorbidities (health and social care coordination,&#xD;
      monitoring, self-management of the patient and informal care giver). ICT platforms and&#xD;
      communication channels that allow sharing information between healthcare and social care&#xD;
      professionals involved in the delivery care of these patients, facilitating their&#xD;
      coordination, increasing their resoluteness and avoiding duplicities when tackling patients´&#xD;
      diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based&#xD;
      platforms can improve the adherence to treatment, enhance self-care and increase patient&#xD;
      awareness about their health status , as well as, improve the empowerment of informal&#xD;
      caregivers, who usually take care of these patients.&#xD;
&#xD;
      According to this, it is hypothesized that the benefit of integrated care programmes based on&#xD;
      (1) integrated care coordination and (2) patient empowerment &amp; home support pathways&#xD;
      supported by ICT is greater and essential for these patients. Care pathways will cut across&#xD;
      organisational boundaries and will activate the most appropriate resources across the entire&#xD;
      spectrum of healthcare and social care services available for both scheduled and emergency&#xD;
      care. CareWell aims to scale up the services in pioneer regions and share their approach,&#xD;
      learning from and supporting the other pilot sites which are at different levels of maturity&#xD;
      in respect to designing, developing and implementing new ways of providing integrated care&#xD;
      services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Frail elderly patients are characterised as having complex health and social care needs; they&#xD;
      are at risk of hospital or residential care home admission, and require a range of high level&#xD;
      interventions due to their frailty and multiple chronic conditions. A growing proportion of&#xD;
      the population in OECD countries are age 65 and over: 15% in 2010, and expected to reach 22%&#xD;
      by 2030. More than half of all older people have at least three chronic conditions, and a&#xD;
      significant proportion have five or more.&#xD;
&#xD;
      A recent US study indicates that more than 95% of Medicare patients with a chronic disease&#xD;
      such as congestive heart failure, depression, or diabetes have at least one other chronic&#xD;
      condition, and the majority (80%, 71%, and 56%, respectively) have four or more chronic&#xD;
      conditions. The CareWell project deals with multimorbid frail patients. Typically these&#xD;
      patients have several diagnoses, the most frequent ones are:&#xD;
&#xD;
        -  Chronic Obstructive Pulmonary Disease (COPD),&#xD;
&#xD;
        -  Diabetes and&#xD;
&#xD;
        -  Congestive Heart Failure (CHF).&#xD;
&#xD;
      The main objective of the CareWell study is to explore the data collection and analysis of&#xD;
      health services' use. All sites are requested to upload their available data regarding&#xD;
      service use, their flow chart on recruitment, and the demographic characteristics of end&#xD;
      users. The evaluation has been conducted using the MAST multi-dimensional evaluation&#xD;
      methodology adapted to the needs of CareWell project focusing on integrated healthcare.&#xD;
&#xD;
      MAST includes assessment of the outcomes of telemedicine applications divided into the&#xD;
      following seven domains:&#xD;
&#xD;
        1. health problem and characteristics of the application;&#xD;
&#xD;
        2. safety;&#xD;
&#xD;
        3. clinical effectiveness;&#xD;
&#xD;
        4. patient perspectives;&#xD;
&#xD;
        5. economic aspects;&#xD;
&#xD;
        6. organisational aspects and&#xD;
&#xD;
        7. socio-cultural, ethical and legal aspects. Each domain will be addressed and studied&#xD;
           through a range of methodological approaches, quantitative, qualitative and modelling.&#xD;
&#xD;
      Patients distributed in six sites will be recruited and assessed at baseline and be followed&#xD;
      up during a period of six months. Data is to be collected from different sources, including&#xD;
      administrative databases, questionnaires and personal interviews.&#xD;
&#xD;
      All 6 CareWell sites are to conduct cohort studies, which means that a group of people with&#xD;
      similar characteristics are followed over a period of time. Potential participants are&#xD;
      selected by screening electronic healthcare records and/or the hospital / national databases&#xD;
      and/or during long term condition annual reviews in the community setting.&#xD;
&#xD;
      Candidates are informed about the nature and the objectives of the evaluation. Once&#xD;
      candidates have signed the informed consent form, if necessary, they participate in the&#xD;
      evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total number of hospital admissions per participant measured at end of study (at approx 12 months)</measure>
    <time_frame>Total of hospital admissions as measured after (approximately) 12 months (= end of study)</time_frame>
    <description>The total of (planned and unplanned) hospital admissions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in generic health related/functional quality of life (1) by assessing Charlson Comorbidity Index (CCI)</measure>
    <time_frame>Change in CCI between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Charlson Comorbidity Index (CCI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Generic health related/functional quality of life (2) by assessing Barthel index</measure>
    <time_frame>Change in Generic health related/functional quality of life as assessed based on BARTHEL INDEX scores between baseline and (approximately) after 12 months (=end of study)</time_frame>
    <description>Barthel index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychological measures (1) by assessing Geriatric Depression Scale</measure>
    <time_frame>Changes in Psychological measures as assessed based on GDS-SF between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)</time_frame>
    <description>Geriatric Depression Scale (GDS Short Form)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychological measures (2) by measuring Hospital Anxiety and Depression Scale</measure>
    <time_frame>Changes in Psychological measures as assessed based on HADS measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the User perspectives (1) by measuring PIRU questionnaire on user experience of Integrated Care (IC) by measuring Policy Research Unit in Policy Innovation Research questionnaire</measure>
    <time_frame>Changes in User perspectives as assessed based on PIRU scores between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)</time_frame>
    <description>Policy Research Unit in Policy Innovation Research (PIRU) questionnaire on user experience of Integrated Care (IC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in User perspectives (3) by measuring Carer perspectives of integration according to eCCIS</measure>
    <time_frame>Changes in User perspectives as assessed based on eCCIS measurements of CARERS between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)</time_frame>
    <description>Carer perspectives of integration according to eCCIS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in User perspectives (4) by measurement of NHS LTC6 Questionnaire</measure>
    <time_frame>Changes in NHS-LTC6 measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)</time_frame>
    <description>National Health Services (NHS) LTC6 Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic aspects (1) as measured based on the total of Efforts related to service development &amp; implementation during the study (between start and 12 months)</measure>
    <time_frame>Economic aspects as assessed based on measurements of total efforts related to Development and Implementation of Services during the period between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Efforts related to service development &amp; implementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Economic aspects (2) as measured based on the total of Efforts related to service during the operation or use of the study (between starts and 12 months)</measure>
    <time_frame>Economic aspects as assessed based on measurements of total efforts related to Service Operations during the period between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Efforts related to service operation or use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Economic aspects (3) as measured based on the total of Equipment costs during the project, between start and after 12 months</measure>
    <time_frame>Economic aspects as assessed based on measurements of total of Costs of Equipment during the period between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Equipment costs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Economic aspects (4) based on measurements of Service effectiveness benefits during study (between start and 12 months)</measure>
    <time_frame>Total of Benefits in Effectiveness of Services during the period between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Service effectiveness benefits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in of Economic aspects (5) based on measurements of Service efficiency benefits during study (between start and 12 months)</measure>
    <time_frame>Economic aspects as assessed based on measurements of total of Benefits in Efficiency of Services during the period between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Service efficiency benefits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Economic aspects (6) based on changes in measurements Changes Willingness to pay between start en end of study (12 months)</measure>
    <time_frame>Economic aspects as assessed based on measurements of Changes in Willingness To Pay for Services between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Changes Willingness to pay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on Organisational aspects (1) as measured with impact on staff between start and study end (after 12 months)</measure>
    <time_frame>Total of Services' Impact On Staff during the period between baseline after (approximately) 12 months (=end of study)</time_frame>
    <description>Impacts on staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on Organisational aspects (2) as measured with impact on involved organisations between start study and end (12 months)</measure>
    <time_frame>Total of Services' Impact On Organisations during the period between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Impacts on organisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Overall service effectiveness and specific outcome measures (1) as measured with Admission-Discharge Duration of admissions between start and study end</measure>
    <time_frame>Changes in Overall service effectiveness and specific outcome assessed based on change between Average of Duration of each Admission throughout study between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Admission-Discharge Duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Overall service effectiveness and specific outcome measures (2) as measured with Indication for hospitalisation of all admissions between start and study end (12 months)</measure>
    <time_frame>Changes in Overall service effectiveness and specific outcome by recording of Admission Indication throughout study between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Indication for hospitalisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Overall service effectiveness and specific outcome measures (3) as measured with Re-hospitalisation rates within 30 days after dismissal between start and end study (12 months)</measure>
    <time_frame>Changes in Overall service effectiveness and specific outcome as assessed based on change between measurements of total of re-hospitalization within 30 days after last admission throughout study between baseline and after (approx.) 12 months (=study end)</time_frame>
    <description>Re-hospitalisation within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Overall service effectiveness and specific outcome measures (4) as assessed with Origin before Admission of all admissions between start and end of study (12 months)</measure>
    <time_frame>Changes in Overall service effectiveness and specific outcome by recording of Origin ad each Admission throughout study between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Origin before Admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Overall service effectiveness and specific outcome measures (5) as assessed with Discharge destiny of all discharges between start and end of study (12 months)</measure>
    <time_frame>Changes in Overall service effectiveness and specific outcome by recording of Destiny after each discharge throughout study between baseline and end of study (12 months)</time_frame>
    <description>Discharge destiny</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disease specific health status measurement (1) as measured with HbA1c of diabetes patients between start and end of study (12 months)</measure>
    <time_frame>Changes in Disease specific health status based on measurements of HbA1c between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disease specific health status measurement (2) as measured with blood glucose levels of all diabetes patients between start and end of study (12 months)</measure>
    <time_frame>Changes in Disease specific health status based on measurements of Blood Glucose between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disease specific health status measurement (3) as measured with heart rate measurements of all chronic heart failure patients between start and study end (12 months)</measure>
    <time_frame>Changes in Disease specific health status based on measurements of Heart Rate between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disease specific health status measurement (4) as measured with blood pressure of all patients with chronic heart failure between start and end of study (12 months)</measure>
    <time_frame>Changes in Disease specific health status based on measurements of blood Pressure between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Disease specific health status measurement (5) as measured with weight of all patients with chronic heart failure between start and end of study (12 months)</measure>
    <time_frame>Changes in Disease specific health status based on measurements of Weight between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>Weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disease specific health status measurement (6) as measured with BMI of all patients with chronic heart failure between start and end of study (12 months)</measure>
    <time_frame>Changes in BMI between baseline and after (approximately) 12 months (=end of study)</time_frame>
    <description>BMI</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1712</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Diabetes</condition>
  <condition>Chronic Heart Failure</condition>
  <condition>Frail Elderly Syndrome</condition>
  <arm_group>
    <arm_group_label>Study group 'New Care'</arm_group_label>
    <description>Frail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>New Care</intervention_name>
    <description>New organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform).</description>
    <arm_group_label>Study group 'New Care'</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Frail elderly living in one of the 6 CareWell sites&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥65 years.&#xD;
&#xD;
          2. Presence of at least two chronic diseases included in the Charlson Comorbidity Index&#xD;
             (CCI) [4]. At least one of the comorbid conditions must be one of the following&#xD;
             conditions: Chronic obstructive pulmonary disease (COPD), diabetes mellitus (both&#xD;
             insulin-dependent and noninsulin-dependent) or chronic heart failure (CHF).&#xD;
&#xD;
          3. Fulfilling local/national/organisational criteria of frailty: increased vulnerability,&#xD;
             complex health needs, and at high risk of hospital or care home admission.&#xD;
&#xD;
          4. Participants have to be able to understand and to comply with study instructions and&#xD;
             requirement, either independently or with help from a carer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have either been registered with an active cancer diagnosis under&#xD;
             treatment, have undergone an organ transplant, or are undergoing dialysis prior to&#xD;
             enrolment.&#xD;
&#xD;
          2. Subjects who are candidates for palliative care (with life expectancy less than one&#xD;
             year, clinically evaluated).&#xD;
&#xD;
          3. People with an AIDS diagnosis.&#xD;
&#xD;
          4. People living in care homes where their daily health, care and wellbeing needs are met&#xD;
             by staff (nurses and support staff) employed within the home.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Higher or Secondary Education Establishments</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agenzia Regionale Sanitaria Pugliese</name>
      <address>
        <city>Bari</city>
        <zip>70126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urzad Marszalkowski Wojewodztwa Dolnoslaskiego</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-411</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicio Vasco de Salud Osakidetza</name>
      <address>
        <city>Vitoria-Gasteiz</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronllys Hospital</name>
      <address>
        <city>Bronllys</city>
        <zip>LD3 0LS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://carewell-project.eu/norm/home.html</url>
    <description>Project Website CareWell</description>
  </link>
  <reference>
    <citation>Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.</citation>
    <PMID>22617736</PMID>
  </reference>
  <reference>
    <citation>Agha Z, Schapira RM, Maker AH. Cost effectiveness of telemedicine for the delivery of outpatient pulmonary care to a rural population. Telemed J E Health. 2002 Fall;8(3):281-91. doi: 10.1089/15305620260353171.</citation>
    <PMID>12419022</PMID>
  </reference>
  <reference>
    <citation>Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.</citation>
    <PMID>19001484</PMID>
  </reference>
  <reference>
    <citation>Kopec JA, Fines P, Manuel DG, Buckeridge DL, Flanagan WM, Oderkirk J, Abrahamowicz M, Harper S, Sharif B, Okhmatovskaia A, Sayre EC, Rahman MM, Wolfson MC. Validation of population-based disease simulation models: a review of concepts and methods. BMC Public Health. 2010 Nov 18;10:710. doi: 10.1186/1471-2458-10-710.</citation>
    <PMID>21087466</PMID>
  </reference>
  <reference>
    <citation>Speroff T, O'Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. doi: 10.1097/00019514-200401000-00002.</citation>
    <PMID>14976904</PMID>
  </reference>
  <reference>
    <citation>Hiligsmann M, Gathon HJ, Bruyere O, Ethgen O, Rabenda V, Reginster JY. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010 Jun-Jul;13(4):394-401. doi: 10.1111/j.1524-4733.2009.00687.x. Epub 2010 Jan 21.</citation>
    <PMID>20102558</PMID>
  </reference>
  <reference>
    <citation>Lega F, DePietro C. Converging patterns in hospital organization: beyond the professional bureaucracy. Health Policy. 2005 Nov;74(3):261-81. doi: 10.1016/j.healthpol.2005.01.010.</citation>
    <PMID>16226138</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Him SA</investigator_affiliation>
    <investigator_full_name>Wouter A Keijser</investigator_full_name>
    <investigator_title>General Manager of KRONIKGUNE, the Basque Centre for Health Services Research and Chronicity.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03042039
org study id: CareWell_EC_Grant No. 620983
nct id: NCT03042039
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
CareWell will enable the delivery of integrated healthcare to frail elderly patients in a
      pilot setting through comprehensive multidisciplinary integrated care programmes where the
      role of ICTs can foster the coordination and patient centered delivery care. Carewell will
      focus in particular complex, multi-morbid elderly patients, who the patients most in need of
      health and social care resources (35% the total cost of Health Care System) and more complex
      interventions due to their frailty and comorbidities (health and social care coordination,
      monitoring, self-management of the patient and informal care giver). ICT platforms and
      communication channels that allow sharing information between healthcare and social care
      professionals involved in the delivery care of these patients, facilitating their
      coordination, increasing their resoluteness and avoiding duplicities when tackling patients´
      diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based
      platforms can improve the adherence to treatment, enhance self-care and increase patient
      awareness about their health status , as well as, improve the empowerment of informal
      caregivers, who usually take care of these patients.

      According to this, it is hypothesized that the benefit of integrated care programmes based on
      (1) integrated care coordination and (2) patient empowerment & home support pathways
      supported by ICT is greater and essential for these patients. Care pathways will cut across
      organisational boundaries and will activate the most appropriate resources across the entire
      spectrum of healthcare and social care services available for both scheduled and emergency
      care. CareWell aims to scale up the services in pioneer regions and share their approach,
      learning from and supporting the other pilot sites which are at different levels of maturity
      in respect to designing, developing and implementing new ways of providing integrated care
      services.
Frail elderly patients are characterised as having complex health and social care needs; they
      are at risk of hospital or residential care home admission, and require a range of high level
      interventions due to their frailty and multiple chronic conditions. A growing proportion of
      the population in OECD countries are age 65 and over: 15% in 2010, and expected to reach 22%
      by 2030. More than half of all older people have at least three chronic conditions, and a
      significant proportion have five or more.

      A recent US study indicates that more than 95% of Medicare patients with a chronic disease
      such as congestive heart failure, depression, or diabetes have at least one other chronic
      condition, and the majority (80%, 71%, and 56%, respectively) have four or more chronic
      conditions. The CareWell project deals with multimorbid frail patients. Typically these
      patients have several diagnoses, the most frequent ones are:

        -  Chronic Obstructive Pulmonary Disease (COPD),

        -  Diabetes and

        -  Congestive Heart Failure (CHF).

      The main objective of the CareWell study is to explore the data collection and analysis of
      health services' use. All sites are requested to upload their available data regarding
      service use, their flow chart on recruitment, and the demographic characteristics of end
      users. The evaluation has been conducted using the MAST multi-dimensional evaluation
      methodology adapted to the needs of CareWell project focusing on integrated healthcare.

      MAST includes assessment of the outcomes of telemedicine applications divided into the
      following seven domains:

        1. health problem and characteristics of the application;

        2. safety;

        3. clinical effectiveness;

        4. patient perspectives;

        5. economic aspects;

        6. organisational aspects and

        7. socio-cultural, ethical and legal aspects. Each domain will be addressed and studied
           through a range of methodological approaches, quantitative, qualitative and modelling.

      Patients distributed in six sites will be recruited and assessed at baseline and be followed
      up during a period of six months. Data is to be collected from different sources, including
      administrative databases, questionnaires and personal interviews.

      All 6 CareWell sites are to conduct cohort studies, which means that a group of people with
      similar characteristics are followed over a period of time. Potential participants are
      selected by screening electronic healthcare records and/or the hospital / national databases
      and/or during long term condition annual reviews in the community setting.

      Candidates are informed about the nature and the objectives of the evaluation. Once
      candidates have signed the informed consent form, if necessary, they participate in the
      evaluation.
observational model: Case-Control
time perspective: Prospective
measure: Total number of hospital admissions per participant measured at end of study (at approx 12 months)
time frame: Total of hospital admissions as measured after (approximately) 12 months (= end of study)
description: The total of (planned and unplanned) hospital admissions
measure: Change in generic health related/functional quality of life (1) by assessing Charlson Comorbidity Index (CCI)
time frame: Change in CCI between baseline and after (approximately) 12 months (=end of study)
description: Charlson Comorbidity Index (CCI)
measure: Change in Generic health related/functional quality of life (2) by assessing Barthel index
time frame: Change in Generic health related/functional quality of life as assessed based on BARTHEL INDEX scores between baseline and (approximately) after 12 months (=end of study)
description: Barthel index
measure: Change in Psychological measures (1) by assessing Geriatric Depression Scale
time frame: Changes in Psychological measures as assessed based on GDS-SF between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
description: Geriatric Depression Scale (GDS Short Form)
measure: Change in Psychological measures (2) by measuring Hospital Anxiety and Depression Scale
time frame: Changes in Psychological measures as assessed based on HADS measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
description: Hospital Anxiety and Depression Scale (HADS Scale)
measure: Changes in the User perspectives (1) by measuring PIRU questionnaire on user experience of Integrated Care (IC) by measuring Policy Research Unit in Policy Innovation Research questionnaire
time frame: Changes in User perspectives as assessed based on PIRU scores between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
description: Policy Research Unit in Policy Innovation Research (PIRU) questionnaire on user experience of Integrated Care (IC)
measure: Changes in User perspectives (3) by measuring Carer perspectives of integration according to eCCIS
time frame: Changes in User perspectives as assessed based on eCCIS measurements of CARERS between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
description: Carer perspectives of integration according to eCCIS
measure: Changes in User perspectives (4) by measurement of NHS LTC6 Questionnaire
time frame: Changes in NHS-LTC6 measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
description: National Health Services (NHS) LTC6 Questionnaire
measure: Economic aspects (1) as measured based on the total of Efforts related to service development & implementation during the study (between start and 12 months)
time frame: Economic aspects as assessed based on measurements of total efforts related to Development and Implementation of Services during the period between baseline and after (approximately) 12 months (=end of study)
description: Efforts related to service development & implementation
measure: Changes in Economic aspects (2) as measured based on the total of Efforts related to service during the operation or use of the study (between starts and 12 months)
time frame: Economic aspects as assessed based on measurements of total efforts related to Service Operations during the period between baseline and after (approximately) 12 months (=end of study)
description: Efforts related to service operation or use
measure: Changes in Economic aspects (3) as measured based on the total of Equipment costs during the project, between start and after 12 months
time frame: Economic aspects as assessed based on measurements of total of Costs of Equipment during the period between baseline and after (approximately) 12 months (=end of study)
description: Equipment costs
measure: Changes in Economic aspects (4) based on measurements of Service effectiveness benefits during study (between start and 12 months)
time frame: Total of Benefits in Effectiveness of Services during the period between baseline and after (approximately) 12 months (=end of study)
description: Service effectiveness benefits
measure: Changes in of Economic aspects (5) based on measurements of Service efficiency benefits during study (between start and 12 months)
time frame: Economic aspects as assessed based on measurements of total of Benefits in Efficiency of Services during the period between baseline and after (approximately) 12 months (=end of study)
description: Service efficiency benefits
measure: Changes in Economic aspects (6) based on changes in measurements Changes Willingness to pay between start en end of study (12 months)
time frame: Economic aspects as assessed based on measurements of Changes in Willingness To Pay for Services between baseline and after (approximately) 12 months (=end of study)
description: Changes Willingness to pay
measure: Impact on Organisational aspects (1) as measured with impact on staff between start and study end (after 12 months)
time frame: Total of Services' Impact On Staff during the period between baseline after (approximately) 12 months (=end of study)
description: Impacts on staff
measure: Impact on Organisational aspects (2) as measured with impact on involved organisations between start study and end (12 months)
time frame: Total of Services' Impact On Organisations during the period between baseline and after (approximately) 12 months (=end of study)
description: Impacts on organisation
measure: Changes in Overall service effectiveness and specific outcome measures (1) as measured with Admission-Discharge Duration of admissions between start and study end
time frame: Changes in Overall service effectiveness and specific outcome assessed based on change between Average of Duration of each Admission throughout study between baseline and after (approximately) 12 months (=end of study)
description: Admission-Discharge Duration
measure: Changes in Overall service effectiveness and specific outcome measures (2) as measured with Indication for hospitalisation of all admissions between start and study end (12 months)
time frame: Changes in Overall service effectiveness and specific outcome by recording of Admission Indication throughout study between baseline and after (approximately) 12 months (=end of study)
description: Indication for hospitalisation
measure: Changes in Overall service effectiveness and specific outcome measures (3) as measured with Re-hospitalisation rates within 30 days after dismissal between start and end study (12 months)
time frame: Changes in Overall service effectiveness and specific outcome as assessed based on change between measurements of total of re-hospitalization within 30 days after last admission throughout study between baseline and after (approx.) 12 months (=study end)
description: Re-hospitalisation within 30 days
measure: Change in Overall service effectiveness and specific outcome measures (4) as assessed with Origin before Admission of all admissions between start and end of study (12 months)
time frame: Changes in Overall service effectiveness and specific outcome by recording of Origin ad each Admission throughout study between baseline and after (approximately) 12 months (=end of study)
description: Origin before Admission
measure: Change in Overall service effectiveness and specific outcome measures (5) as assessed with Discharge destiny of all discharges between start and end of study (12 months)
time frame: Changes in Overall service effectiveness and specific outcome by recording of Destiny after each discharge throughout study between baseline and end of study (12 months)
description: Discharge destiny
measure: Change in Disease specific health status measurement (1) as measured with HbA1c of diabetes patients between start and end of study (12 months)
time frame: Changes in Disease specific health status based on measurements of HbA1c between baseline and after (approximately) 12 months (=end of study)
description: HbA1c
measure: Change in Disease specific health status measurement (2) as measured with blood glucose levels of all diabetes patients between start and end of study (12 months)
time frame: Changes in Disease specific health status based on measurements of Blood Glucose between baseline and after (approximately) 12 months (=end of study)
description: Blood glucose
measure: Change in Disease specific health status measurement (3) as measured with heart rate measurements of all chronic heart failure patients between start and study end (12 months)
time frame: Changes in Disease specific health status based on measurements of Heart Rate between baseline and after (approximately) 12 months (=end of study)
description: Heart rate
measure: Change in Disease specific health status measurement (4) as measured with blood pressure of all patients with chronic heart failure between start and end of study (12 months)
time frame: Changes in Disease specific health status based on measurements of blood Pressure between baseline and after (approximately) 12 months (=end of study)
description: Blood pressure
measure: Change of Disease specific health status measurement (5) as measured with weight of all patients with chronic heart failure between start and end of study (12 months)
time frame: Changes in Disease specific health status based on measurements of Weight between baseline and after (approximately) 12 months (=end of study)
description: Weight
measure: Change in Disease specific health status measurement (6) as measured with BMI of all patients with chronic heart failure between start and end of study (12 months)
time frame: Changes in BMI between baseline and after (approximately) 12 months (=end of study)
description: BMI
arm group label: Study group 'New Care'
description: Frail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually.
intervention type: Other
intervention name: New Care
description: New organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform).
arm group label: Study group 'New Care'
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
country: Croatia
country: Italy
country: Poland
country: Spain
country: United Kingdom
url: http://carewell-project.eu/norm/home.html
description: Project Website CareWell
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PMID: 22617736
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PMID: 12419022
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PMID: 19001484
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PMID: 21087466
citation: Speroff T, O'Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. doi: 10.1097/00019514-200401000-00002.
PMID: 14976904
citation: Hiligsmann M, Gathon HJ, Bruyere O, Ethgen O, Rabenda V, Reginster JY. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010 Jun-Jul;13(4):394-401. doi: 10.1111/j.1524-4733.2009.00687.x. Epub 2010 Jan 21.
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PMID: 16226138
responsible party type: Principal Investigator
investigator affiliation: Him SA
investigator full name: Wouter A Keijser
investigator title: General Manager of KRONIKGUNE, the Basque Centre for Health Services Research and Chronicity.
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No