xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026293</url>
    </required_header>
    <id_info>
      <org_study_id>CER_study</org_study_id>
      <nct_id>NCT06026293</nct_id>
    </id_info>
    <brief_title>Pharmacoeconomic Evaluation of the Cost/Effectiveness Ratio of Physical Exercise on Non-alcoholic Fatty Liver Disease</brief_title>
    <official_title>Retrospective and Prospective Study Aimed at the Pharmacoeconomic Evaluation of the Cost/Effectiveness Ratio of Physical Exercise on the Prognosis of Non-alcoholic Fatty Liver Disease (NAFLD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Antonella Bianco</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Pietro Trisolini</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Giuseppe Dalfino</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</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>
        Physical inactivity and poor dietary habits are associated with an increased risk of obesity&#xD;
        and chronic disease (World Health Organization, 2019; Glanz and Bishop, 2010). Conversely,&#xD;
        higher levels of total physical activity result in a reduced risk of cardiovascular disease,&#xD;
        breast and colon cancer, and diabetes (Kyu et al., 2016). Similarly, consumption of the&#xD;
        minimum recommended level (600 g per day) of fruit and vegetables is associated with a lower&#xD;
        risk of cardiovascular disease and cancer (Ezzati et al., 2004). However, despite these&#xD;
        recognized benefits, unhealthy diet and physical inactivity are still major contributors to&#xD;
        poor health and rising health care costs. Worldwide, physical inactivity accounted for 13.4&#xD;
        million disability-adjusted life years (DALYs) in 2013 and cost $53.8 billion to health&#xD;
        systems and an additional $13.7 billion in productivity due to deaths attributable to&#xD;
        physical inactivity (Ding et al., 2016).&#xD;
  &#xD;
        Pharmacoeconomics, or the economic evaluation of treatments aimed at maintaining the health&#xD;
        of the population, is a set of evaluation models used to identify the value (convenience) and&#xD;
        the overall economic impact of a possible treatment.&#xD;
  &#xD;
        The results of economic evaluations help decision makers inform their choice. Their advantage&#xD;
        is that the result is obtained by applying known and validated models, and everyone can know&#xD;
        the basis of the decision (evidence-based decision making). The clinical-economic value and&#xD;
        the overall financial impact must be compared with the willingness to pay the related costs.&#xD;
  &#xD;
        Economic evaluations are a tool for defining the value of a medicine in terms of&#xD;
        cost-opportunity, from the point of view of the patient, the NHS and society as a whole.&#xD;
  &#xD;
        The definition of &quot;value&quot; is very broad, multidimensional and includes concepts from many&#xD;
        disciplines, beyond economics. Specifically, economic evaluations that take into&#xD;
        consideration new medicines, innovative or not, the value is given by the marginal utility&#xD;
        that the patient, the NHS and/or society can obtain from its acquisition. In this regard, the&#xD;
        measurement of years of life gained in full quality of life (QALY - quality-adjusted life&#xD;
        years) is widely applied to medicines in various regulatory contexts, albeit with the&#xD;
        awareness that it is not able to capture all the elements that contribute to value (Carletto,&#xD;
        A et al.; Drummond, M. F)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cost/effectiveness Ratio</measure>
      <time_frame>3 years</time_frame>
      <description>to define the economic value in terms of CER (Cost/Effectiveness Ratio) and ICER (Incremental Cost/Effectivness Ratio) of physical exercise in the treatment of NAFLD in patients who already have comorbidities for metabolic/cardiometabolic diseases.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>long term foresight of an healthy policy</measure>
      <time_frame>3 years</time_frame>
      <description>identify the potential savings in terms of costs (direct and indirect) of physical exercise on patients suffering from NAFLD through the use of a predictive scenario developed through the use of the MAFEIP (Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Aging).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Non-Alcoholic Fatty Liver Disease</condition>
    <arm_group>
      <arm_group_label>subjects that participates to a previous clinical trial</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The population was affected by NAFLD in the observation period (2018-2020), participating&#xD;
          in health promotion activities by performing physical exercise under the supervision of the&#xD;
          institution's kinesiologists&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being affected by NAFLD in the observation period (2018-2020)&#xD;
  &#xD;
            -  Participating in health promotion activities by performing physical exercise under the&#xD;
               supervision of the institution's kinesiologists&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient deceased&#xD;
  &#xD;
            -  Patient who does not agree to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maurizio Gaetano Polignano</last_name>
      <role>Principal Investigator</role>
      <affiliation>IRCCS &quot;Saverio de Bellis&quot;</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Irccs Saverio de Bellis</name>
        <address>
          <city>Castellana Grotte</city>
          <state>Bari</state>
          <zip>70013</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</investigator_affiliation>
      <investigator_full_name>Maurizio Gaetano Polignano</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>Non-alcoholic fatty liver desease</keyword>
    <keyword>Cost/effectivness</keyword>
    <keyword>Physical activity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026293
  org study id: CER_study
  nct id: NCT06026293
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Physical inactivity and poor dietary habits are associated with an increased risk of obesity
        and chronic disease (World Health Organization, 2019; Glanz and Bishop, 2010). Conversely,
        higher levels of total physical activity result in a reduced risk of cardiovascular disease,
        breast and colon cancer, and diabetes (Kyu et al., 2016). Similarly, consumption of the
        minimum recommended level (600 g per day) of fruit and vegetables is associated with a lower
        risk of cardiovascular disease and cancer (Ezzati et al., 2004). However, despite these
        recognized benefits, unhealthy diet and physical inactivity are still major contributors to
        poor health and rising health care costs. Worldwide, physical inactivity accounted for 13.4
        million disability-adjusted life years (DALYs) in 2013 and cost $53.8 billion to health
        systems and an additional $13.7 billion in productivity due to deaths attributable to
        physical inactivity (Ding et al., 2016).
  
        Pharmacoeconomics, or the economic evaluation of treatments aimed at maintaining the health
        of the population, is a set of evaluation models used to identify the value (convenience) and
        the overall economic impact of a possible treatment.
  
        The results of economic evaluations help decision makers inform their choice. Their advantage
        is that the result is obtained by applying known and validated models, and everyone can know
        the basis of the decision (evidence-based decision making). The clinical-economic value and
        the overall financial impact must be compared with the willingness to pay the related costs.
  
        Economic evaluations are a tool for defining the value of a medicine in terms of
        cost-opportunity, from the point of view of the patient, the NHS and society as a whole.
  
        The definition of "value" is very broad, multidimensional and includes concepts from many
        disciplines, beyond economics. Specifically, economic evaluations that take into
        consideration new medicines, innovative or not, the value is given by the marginal utility
        that the patient, the NHS and/or society can obtain from its acquisition. In this regard, the
        measurement of years of life gained in full quality of life (QALY - quality-adjusted life
        years) is widely applied to medicines in various regulatory contexts, albeit with the
        awareness that it is not able to capture all the elements that contribute to value (Carletto,
        A et al.; Drummond, M. F)
  observational model: Cohort
  time perspective: Other
  measure: Cost/effectiveness Ratio
  time frame: 3 years
  description: to define the economic value in terms of CER (Cost/Effectiveness Ratio) and ICER (Incremental Cost/Effectivness Ratio) of physical exercise in the treatment of NAFLD in patients who already have comorbidities for metabolic/cardiometabolic diseases.
  measure: long term foresight of an healthy policy
  time frame: 3 years
  description: identify the potential savings in terms of costs (direct and indirect) of physical exercise on patients suffering from NAFLD through the use of a predictive scenario developed through the use of the MAFEIP (Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Aging).
  arm group label: subjects that participates to a previous clinical trial
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Maurizio Gaetano Polignano
  role: Principal Investigator
  affiliation: IRCCS "Saverio de Bellis"
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
  investigator full name: Maurizio Gaetano Polignano
  investigator title: principal investigator
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease