<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/NCT03018717</url>
  </required_header>
  <id_info>
    <org_study_id>ATLAN_TIC01</org_study_id>
    <nct_id>NCT03018717</nct_id>
  </id_info>
  <brief_title>Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases</brief_title>
  <acronym>ATLAN_TIC01</acronym>
  <official_title>Randomized Multicenter Clinical Trial of a Integral Clinical Care Plan Shared With or Without Telemonitoring of Bio Constants in Patients With Chronic Diseases in Advanced Stages. ATLANTIC Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza Progreso y Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Telefónica S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agency of Social Services and Dependency of Andalusia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Salud Responde</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Andalusian Network for Design and Translation of Advanced Therapies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Information and communications technologies (ICT) currently constitute a key element in the&#xD;
      innovation and improvement of providing health-care to frail populations with advanced&#xD;
      chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven&#xD;
      conclusively. The investigators are going to carry out a multi-center, randomized, parallel&#xD;
      groups, phase III clinical trial in adult patient with heart and/or lung advanced&#xD;
      diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of&#xD;
      bio-parameters added to optimal standard of clinical care (shared clinical care plan)&#xD;
      compared to the shared clinical care plan exclusively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a total number of 510 patients will be divided in 3 centers: Hospital University Virgen del&#xD;
      Rocío; Hospital University Virgen Macarena and Public Hospital Comarcal of Serranía de Ronda.&#xD;
      Patient will be randomized in Tele-monitoring Constant (TELEPAC) To analyze the efficacy and&#xD;
      cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared&#xD;
      comprehensive clinical care plan or in Standard Clinical Care (PAC) based on a comprehensive&#xD;
      clinical assistance shared between Primary Care and Hospital Care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 13, 2016</start_date>
  <completion_date type="Anticipated">September 13, 2019</completion_date>
  <primary_completion_date type="Actual">September 26, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduce the number of hospital admissions and / or the number of hospital emergency visits and / or the number of primary care visits of the patients in the TELEPAC arm (patients with tele-monitoring) with respect to the PAC arm (patient without tele-Moni</measure>
    <time_frame>Six month</time_frame>
    <description>Monitoring number of hospitalizations and/or number of emergency visits in the period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions</measure>
    <time_frame>six month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial</measure>
    <time_frame>six month</time_frame>
    <description>analyze the safety of the two arms by monitoring the number of adverse events and adverse clinical events related to the two arms of the clinical trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life related to health, of follow-up in both arms of the clinical trial,</measure>
    <time_frame>At the time of inclusion, at 45 days and after 6 months of follow-up.</time_frame>
    <description>Using a standardized Using a standardized questionnaire of quality of live related to health in adults (EQ-5D) adapted to Spanish.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial.</measure>
    <time_frame>at 45 days and after 6 months of follow-up</time_frame>
    <description>Using the standardized questionnaire Service Performance (SERVPERF) adapted to health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial.</measure>
    <time_frame>at 45 days and after 6 months of follow-up,</time_frame>
    <description>Using the Perceived quality for technical support (TSUQ) standardized questionnaire adapted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method.</measure>
    <time_frame>six month</time_frame>
    <description>using each of the patients that did not require hospital admission and / or emergency visits, as a unit of cost Of each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm.</measure>
    <time_frame>six month</time_frame>
    <description>using each of the secondary efficacy variables as unit of cost and each patient's overall cost unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of admissions-visits to Hospital Emergency</measure>
    <time_frame>six month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of visits to Primary Care Emergencies</measure>
    <time_frame>six month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>six month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of hospital stay</measure>
    <time_frame>six month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall cost for patients in euros</measure>
    <time_frame>six month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">510</enrollment>
  <condition>Chronic Lung Disease</condition>
  <condition>Chronic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Tele-monitoring Constant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>To analyze the efficacy and cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared comprehensive clinical care plan. Patients will receive in their home a kit consisting of a briefcase containing all equipment (scale, pulse-oximeter ... etc) and a logo access to devices (Tablet) through mobile communications m2m between patient and platform Management for Chronic Patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard clinical care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard clinical care plan shared between plan of attention to the patient with Pluri-pathological process and the care plan for patients with chronic diseases, based on a comprehensive clinical assistance shared between Primary Care and Hospital Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemonitoring Constant</intervention_name>
    <description>telemedicine of Constant</description>
    <arm_group_label>Tele-monitoring Constant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard clinical care</intervention_name>
    <description>The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)</description>
    <arm_group_label>Standard clinical care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Majority legal age (18 years of age or older)&#xD;
&#xD;
          -  Present any of the following shortcomings:&#xD;
&#xD;
        Heart failure with baseline dyspnea ≥III of New York Heart Association (NYHA) Chronic&#xD;
        respiratory insufficiency with basal dyspnea ≥III of Medical Research Council (MRC) Scale&#xD;
        and / or oxygen saturation &lt;90% and / or home oxygen therapy.&#xD;
&#xD;
          -  Present Heart Failure or Respiratory Insufficiency with basal dyspnea grade &lt;III&#xD;
             (according to NYHA and MRC respectively) but have presented 2 or more income in the&#xD;
             last year.&#xD;
&#xD;
          -  Score of Patients with terminal or palliative medical diseases (score PALIAR) index&#xD;
             between 0 and 7 points.&#xD;
&#xD;
          -  To present one of the following assistance situations: hospital admission, follow-up&#xD;
             in Home Hospitalization or Palliative Care Teams, specialized outpatient follow-up.&#xD;
&#xD;
          -  Speak, understand, read and write Spanish, either the patient or the primary&#xD;
             caregiver.&#xD;
&#xD;
          -  Have basic knowledge of the use of mobile phones and applications of computer tablets&#xD;
             (such knowledge will be confirmed by personal interview, with test of the device).&#xD;
&#xD;
          -  Informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of malignant neoplastic disease ACTIVE except localized adenocarcinoma of&#xD;
             prostate in hormonal treatment, and / or cutaneous basocellular-squamous cell&#xD;
             carcinoma.&#xD;
&#xD;
          -  In the case of Chronic Renal Disease if there is the possibility of entry into&#xD;
             Substitutive Therapies (hemodialysis or transplantation)&#xD;
&#xD;
          -  In the case of chronic liver disease, if there is a possibility of liver&#xD;
             transplantation.&#xD;
&#xD;
          -  Chronic neurological disease with established cognitive impairment (E. Pfeiffer with 7&#xD;
             or more errors and / or Mild cognitive evaluated (ECM with ≤18 points).&#xD;
&#xD;
          -  Clinical situation of agony.&#xD;
&#xD;
          -  Surprise question (&quot;Would you be surprised if your patient died in the next 6&#xD;
             months?&quot;) With the result &quot;I would not be surprised&quot; + PALIAR Score Score ≥7.5 points.&#xD;
&#xD;
          -  Participate in another tele-health initiative.&#xD;
&#xD;
          -  Go simultaneously to a private health service and / or be institutionalized&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Serranía de Ronda Hospital</name>
      <address>
        <city>Ronda</city>
        <state>Málaga</state>
        <zip>29400</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitary Hospital Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <state>Seville</state>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitary Hospital Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <state>Seville</state>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaén</name>
      <address>
        <city>Jaén</city>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Chronic Disease</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/NCT03018717
org study id: ATLAN_TIC01
nct id: NCT03018717
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Information and communications technologies (ICT) currently constitute a key element in the
      innovation and improvement of providing health-care to frail populations with advanced
      chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven
      conclusively. The investigators are going to carry out a multi-center, randomized, parallel
      groups, phase III clinical trial in adult patient with heart and/or lung advanced
      diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of
      bio-parameters added to optimal standard of clinical care (shared clinical care plan)
      compared to the shared clinical care plan exclusively.
a total number of 510 patients will be divided in 3 centers: Hospital University Virgen del
      Rocío; Hospital University Virgen Macarena and Public Hospital Comarcal of Serranía de Ronda.
      Patient will be randomized in Tele-monitoring Constant (TELEPAC) To analyze the efficacy and
      cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared
      comprehensive clinical care plan or in Standard Clinical Care (PAC) based on a comprehensive
      clinical assistance shared between Primary Care and Hospital Care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Reduce the number of hospital admissions and / or the number of hospital emergency visits and / or the number of primary care visits of the patients in the TELEPAC arm (patients with tele-monitoring) with respect to the PAC arm (patient without tele-Moni
time frame: Six month
description: Monitoring number of hospitalizations and/or number of emergency visits in the period.
measure: Number of hospital admissions
time frame: six month
measure: Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial
time frame: six month
description: analyze the safety of the two arms by monitoring the number of adverse events and adverse clinical events related to the two arms of the clinical trial.
measure: quality of life related to health, of follow-up in both arms of the clinical trial,
time frame: At the time of inclusion, at 45 days and after 6 months of follow-up.
description: Using a standardized Using a standardized questionnaire of quality of live related to health in adults (EQ-5D) adapted to Spanish.
measure: quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial.
time frame: at 45 days and after 6 months of follow-up
description: Using the standardized questionnaire Service Performance (SERVPERF) adapted to health.
measure: perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial.
time frame: at 45 days and after 6 months of follow-up,
description: Using the Perceived quality for technical support (TSUQ) standardized questionnaire adapted
measure: primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method.
time frame: six month
description: using each of the patients that did not require hospital admission and / or emergency visits, as a unit of cost Of each patient.
measure: To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm.
time frame: six month
description: using each of the secondary efficacy variables as unit of cost and each patient's overall cost unit.
measure: Number of admissions-visits to Hospital Emergency
time frame: six month
measure: Number of visits to Primary Care Emergencies
time frame: six month
measure: mortality
time frame: six month
measure: Number of days of hospital stay
time frame: six month
measure: Overall cost for patients in euros
time frame: six month
arm group label: Tele-monitoring Constant
arm group type: Other
description: To analyze the efficacy and cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared comprehensive clinical care plan. Patients will receive in their home a kit consisting of a briefcase containing all equipment (scale, pulse-oximeter ... etc) and a logo access to devices (Tablet) through mobile communications m2m between patient and platform Management for Chronic Patients.
arm group label: Standard clinical care
arm group type: Other
description: Standard clinical care plan shared between plan of attention to the patient with Pluri-pathological process and the care plan for patients with chronic diseases, based on a comprehensive clinical assistance shared between Primary Care and Hospital Care
intervention type: Other
intervention name: Telemonitoring Constant
description: telemedicine of Constant
arm group label: Tele-monitoring Constant
intervention type: Other
intervention name: Standard clinical care
description: The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)
arm group label: Standard clinical care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Heart Diseases
mesh term: Chronic Disease
sharing ipd: No