<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/NCT03752567</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03752567</nct_id>
  </id_info>
  <brief_title>New Patient Support Program in Type 2 Diabetes</brief_title>
  <official_title>&quot;The Community Pharmacist and the Case Management of Diabetic Patient&quot; - No Profit Observational Study on the Role of the Community Pharmacist and the &quot;Pharmacy of the Services&quot; in the Diabetic Patient Case Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Farmacia La Regina s.r.l.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federfarma Campania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federfarma Salerno</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HTN - Health Telematic Network srl</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BSI - Biochemical Systems International spa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Next Sight srl</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Farmacia La Regina s.r.l.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-profit observational study on the role of the community pharmacist and the &quot;pharmacy of&#xD;
      services&quot; in the case management of the diabetic patient&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the last few years, the Italian National Health Service has witnessed numerous and&#xD;
      substantial changes, even more evident if one looks at the workload that this system is&#xD;
      called to face when it comes to chronic diseases. In fact, while the progress of science has&#xD;
      led to better outcomes in the treatment of acute diseases resulting in an increase in the&#xD;
      average age of the population and an increase in the number of people suffering from chronic&#xD;
      diseases, even multiple, on the other the changed socio-economic conditions activities have&#xD;
      led to an increase in the number of elderly and socially fragile individuals. It takes very&#xD;
      little to understand that these epidemiological and socio-sanitary mutations pose a serious&#xD;
      threat to the stability of the investigator's health system.&#xD;
&#xD;
      To meet these new needs, the different countries of the world are analyzing and adopting&#xD;
      various models of chronic disease management. Even if with different methodologies, all the&#xD;
      models developed so far put the patient at the center of attention, in its uniqueness and&#xD;
      with its needs, and propose to provide the latter with complete assistance, through the&#xD;
      integration of health and social services.&#xD;
&#xD;
      In this scenario, also the role of pharmacist, historically linked to the dispensation of&#xD;
      drugs upon presentation of a medical prescription and to a final control action to ensure a&#xD;
      delivery of medicines in total safety, over time has evolved. In order to carry on this&#xD;
      evolution, the pharmacist has been asked for new skills, to realize what has been defined as&#xD;
      &quot;the pharmacy of services&quot;, through which the pharmacist is recognized the possibility of&#xD;
      becoming a strategic figure to meet the changed needs of the population on the one hand and&#xD;
      the Italian National Health System on the other and to support the latter in the transition&#xD;
      from a &quot;waiting&quot; medicine to an &quot;initiative&quot; medicine.&#xD;
&#xD;
      Diabetic disease and the resulting chronic complications, today, have a very significant&#xD;
      impact on patients and their families, on morbidity and mortality, as well as having a strong&#xD;
      economic impact on the health system. Despite this, most of the patients do not carry out&#xD;
      what is foreseen by their diagnostic therapeutic assistance path (PDTA) due to several&#xD;
      reasons such as long waiting times, the need to move to undergo examinations, which is not so&#xD;
      easy for young people of working age as well as older people, lack of homogeneity in access&#xD;
      to care and in the provision of services and more. The community pharmacist, therefore,&#xD;
      represents, for the position in which it is located within the Italian National Health&#xD;
      Service, a potential not yet considered. In fact, it could take on the role of case manager&#xD;
      (a professional who manages one or more cases entrusted to him according to a pre-established&#xD;
      path, such as PDTA, in a defined space-time context) of the patient suffering from type 2&#xD;
      diabetes mellitus due to the capillarity territory, to the hourly availability superior to&#xD;
      any other territorial health structure, to the health skills in its possession and to what it&#xD;
      can offer in terms of services within the so-called &quot;pharmacy of service&quot;.&#xD;
&#xD;
      In this scenario, the pharmacist would not replace any of the other actors already present in&#xD;
      the multidisciplinary care team but would integrate in the same and, moreover, being already&#xD;
      an agreement with the Italian National Health Service, the conferral of this role would not&#xD;
      cause a excessive increase in costs, such as that resulting from the hiring of new staff to&#xD;
      achieve the same objectives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Participants With Adherence to the PDTA</measure>
    <time_frame>12 months</time_frame>
    <description>Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of &quot;pharmacy of service&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waiting Time</measure>
    <time_frame>365 days</time_frame>
    <description>variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of Arterial Pressure</measure>
    <time_frame>12 months</time_frame>
    <description>variation of arterial pressure (Systolic, Diastolic) (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of HbA1c</measure>
    <time_frame>12 months</time_frame>
    <description>variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of LDL-cholesterol</measure>
    <time_frame>12 months</time_frame>
    <description>variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic Impact</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the &quot;pharmacy of service&quot; (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Group study</arm_group_label>
    <description>Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow up</intervention_name>
    <description>like group descriptions</description>
    <arm_group_label>Group study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with type 2 diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Criteria Inclusion:&#xD;
&#xD;
          -  age&gt; 18 years,&#xD;
&#xD;
          -  patients with type 2 diabetes mellitus diagnosis;&#xD;
&#xD;
          -  able to express consent to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Nobody&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raffaele La Regina, dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Farmacia La Regina s.r.l.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Farmacia La Regina dott. Rocco Vito</name>
      <address>
        <city>San Rufo</city>
        <state>Salerno</state>
        <zip>84030</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Gerber BS, Rapacki L, Castillo A, Tilton J, Touchette DR, Mihailescu D, Berbaum ML, Sharp LK. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health. 2012 Oct 23;12:891. doi: 10.1186/1471-2458-12-891.</citation>
    <PMID>23088168</PMID>
  </reference>
  <reference>
    <citation>Brophy L, Williams A, Berman EJ, Keleti D, Michael KE, Shepherd M, Fox SA, Jacobs C, Tan-Torres S, Gelzer AD, Tegenu M. Collaborative DTM reduces hospitalization and healthcare costs in patients with diabetes treated with polypharmacy. Am J Manag Care. 2014 Mar 1;20(3):e72-81.</citation>
    <PMID>24773329</PMID>
  </reference>
  <reference>
    <citation>Davidson MB. The effectiveness of nurse- and pharmacist-directed care in diabetes disease management: a narrative review. Curr Diabetes Rev. 2007 Nov;3(4):280-6. doi: 10.2174/157339907782330058.</citation>
    <PMID>18220688</PMID>
  </reference>
  <reference>
    <citation>Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421.</citation>
    <PMID>18363526</PMID>
  </reference>
  <reference>
    <citation>Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction. Telemed J E Health. 2014 Feb;20(2):135-43. doi: 10.1089/tmj.2013.0145. Epub 2013 Dec 4.</citation>
    <PMID>24303930</PMID>
  </reference>
  <reference>
    <citation>Maxwell LG, McFarland MS, Baker JW, Cassidy RF. Evaluation of the Impact of a Pharmacist-Led Telehealth Clinic on Diabetes-Related Goals of Therapy in a Veteran Population. Pharmacotherapy. 2016 Mar;36(3):348-56. doi: 10.1002/phar.1719. Epub 2016 Mar 11.</citation>
    <PMID>26877253</PMID>
  </reference>
  <reference>
    <citation>Littauer SL, Dixon DL, Mishra VK, Sisson EM, Salgado TM. Pharmacists providing care in the outpatient setting through telemedicine models: a narrative review. Pharm Pract (Granada). 2017 Oct-Dec;15(4):1134. doi: 10.18549/PharmPract.2017.04.1134. Epub 2017 Dec 19.</citation>
    <PMID>29317927</PMID>
  </reference>
  <reference>
    <citation>Barr PJ, McElnay JC, Hughes CM. Connected health care: the future of health care and the role of the pharmacist. J Eval Clin Pract. 2012 Feb;18(1):56-62. doi: 10.1111/j.1365-2753.2010.01522.x. Epub 2010 Aug 4.</citation>
    <PMID>20698917</PMID>
  </reference>
  <reference>
    <citation>Hughes JD, Wibowo Y, Sunderland B, Hoti K. The role of the pharmacist in the management of type 2 diabetes: current insights and future directions. Integr Pharm Res Pract. 2017 Jan 16;6:15-27. doi: 10.2147/IPRP.S103783. eCollection 2017.</citation>
    <PMID>29354547</PMID>
  </reference>
  <reference>
    <citation>Nye AM. A Clinical Pharmacist in Telehealth Team Care for Rural Patients with Diabetes. N C Med J. 2017 May-Jun;78(3):183-184. doi: 10.18043/ncm.78.3.183. No abstract available.</citation>
    <PMID>28576957</PMID>
  </reference>
  <reference>
    <citation>Emilia Romagna region. Causes of non-adherence to the diagnostic-therapeutic treatment of diabetes mellitus: a qualitative-quantitative study for improvement - Final report. June 2018</citation>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <results_first_submitted>January 2, 2020</results_first_submitted>
  <results_first_submitted_qc>February 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 12, 2020</results_first_posted>
  <last_update_submitted>February 1, 2020</last_update_submitted>
  <last_update_submitted_qc>February 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Farmacia La Regina s.r.l.</investigator_affiliation>
    <investigator_full_name>Raffaele La Regina</investigator_full_name>
    <investigator_title>Community pharmacist</investigator_title>
  </responsible_party>
  <keyword>adherence</keyword>
  <keyword>terapy</keyword>
  <keyword>follow up</keyword>
  <keyword>community pharmacy</keyword>
  <keyword>pharmacist</keyword>
  <keyword>case manager</keyword>
  <keyword>telemedicine</keyword>
  <keyword>pharmacy of service</keyword>
  <keyword>fundus camera</keyword>
  <keyword>ecg</keyword>
  <keyword>local pharmacist</keyword>
  <keyword>general physician</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data will be shared only in aggregate and anonymous form.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03752567/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03752567/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment took place in the first 15 days of the operating period (November 1, 2018 - October 31, 2019). The patients were enrolled at the only experimentation center represented by La Regina pharmacy, a community pharmacy in a small rural center in southern Italy.</recruitment_details>
      <pre_assignment_details>None of the enrolled patients were excluded from the ongoing trial. All patients completed the entire observation period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group Study</title>
          <description>Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria).&#xD;
Follow up: like group descriptions</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study participants were assigned the whole study group.</population>
      <group_list>
        <group group_id="B1">
          <title>Group Study</title>
          <description>Enrolled patients include people with reduced glucose tolerance, or impaired fasting blood sugar, or type 2 diabetes free of organ complications, or type 2 diabetes with chronic complications.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.5" spread="9.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Participants With Adherence to the PDTA</title>
        <description>Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of &quot;pharmacy of service&quot;.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Study</title>
            <description>The patients enrolled were 40.&#xD;
Based on the staging of diabetic disease, the enrolled population was made up as follows:&#xD;
reduced glucose tolerance&#xD;
impaired fasting blood sugar&#xD;
type 2 diabetes free of organ complications&#xD;
type 2 diabetes with chronic complications</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Adherence to the PDTA</title>
          <description>Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of &quot;pharmacy of service&quot;.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of adherence to PDTA - 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of adherence to PDTA - 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of adherence to PDTA - 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Waiting Time</title>
        <description>variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)</description>
        <time_frame>365 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Study</title>
            <description>The patients enrolled were 40.&#xD;
Based on the staging of diabetic disease, the enrolled population was made up as follows:&#xD;
reduced glucose tolerance&#xD;
impaired fasting blood sugar&#xD;
type 2 diabetes free of organ complications&#xD;
type 2 diabetes with chronic complications</description>
          </group>
        </group_list>
        <measure>
          <title>Waiting Time</title>
          <description>variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Electrocardiogram waiting list</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117" spread="57.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fundus Oculi waiting list</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120" spread="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Levels of Arterial Pressure</title>
        <description>variation of arterial pressure (Systolic, Diastolic) (mmHg)</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Study</title>
            <description>The patients enrolled were 40.&#xD;
Based on the staging of diabetic disease, the enrolled population was made up as follows:&#xD;
reduced glucose tolerance&#xD;
impaired fasting blood sugar&#xD;
type 2 diabetes free of organ complications&#xD;
type 2 diabetes with chronic complications</description>
          </group>
        </group_list>
        <measure>
          <title>Levels of Arterial Pressure</title>
          <description>variation of arterial pressure (Systolic, Diastolic) (mmHg)</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic pressure variation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic pressure variation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Levels of HbA1c</title>
        <description>variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Study</title>
            <description>The patients enrolled were 40.&#xD;
Based on the staging of diabetic disease, the enrolled population was made up as follows:&#xD;
reduced glucose tolerance&#xD;
impaired fasting blood sugar&#xD;
type 2 diabetes free of organ complications&#xD;
type 2 diabetes with chronic complications</description>
          </group>
        </group_list>
        <measure>
          <title>Levels of HbA1c</title>
          <description>variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Levels of LDL-cholesterol</title>
        <description>variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Study</title>
            <description>The patients enrolled were 40.&#xD;
Based on the staging of diabetic disease, the enrolled population was made up as follows:&#xD;
reduced glucose tolerance&#xD;
impaired fasting blood sugar&#xD;
type 2 diabetes free of organ complications&#xD;
type 2 diabetes with chronic complications</description>
          </group>
        </group_list>
        <measure>
          <title>Levels of LDL-cholesterol</title>
          <description>variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy</description>
          <units>percentage of variation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Economic Impact</title>
        <description>Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the &quot;pharmacy of service&quot; (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Study</title>
            <description>The patients enrolled were 40.&#xD;
Based on the staging of diabetic disease, the enrolled population was made up as follows:&#xD;
reduced glucose tolerance&#xD;
impaired fasting blood sugar&#xD;
type 2 diabetes free of organ complications&#xD;
type 2 diabetes with chronic complications</description>
          </group>
        </group_list>
        <measure>
          <title>Economic Impact</title>
          <description>Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the &quot;pharmacy of service&quot; (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)</description>
          <units>euro/patient/year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210.25" spread="80.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>There wasn't any risk of adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group Study</title>
          <description>The 40 patients enrolled were 50% men and 50% women. The average age was 64.5 years. The median of the comorbidities presented by the participants was two, and in 33% (n = 13) of the cases there were more than 2 comorbidities per patient.&#xD;
Based on the staging of diabetic disease, the enrolled population was made up as follows:&#xD;
reduced glucose tolerance 15%&#xD;
impaired fasting blood sugar 5%&#xD;
type 2 diabetes free of organ complications 38%&#xD;
type 2 diabetes with chronic complications 42%</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Description</sub_title>
                <description>No significant adverse events were detected during the study</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Not Serious Adverse Event</sub_title>
                <description>No significant adverse events were detected during the study</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The monocentric nature of the study and the small number of patients, however statistically adequate, they represent limits, which can be overcome with the replication of the study on more than one wide scale.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Raffaele La Regina</name_or_title>
      <organization>Farmacia La Regina</organization>
      <phone>+393389066138</phone>
      <email>raffaele.laregina@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03752567
org study id: 1
nct id: NCT03752567
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Non-profit observational study on the role of the community pharmacist and the "pharmacy of
      services" in the case management of the diabetic patient
Over the last few years, the Italian National Health Service has witnessed numerous and
      substantial changes, even more evident if one looks at the workload that this system is
      called to face when it comes to chronic diseases. In fact, while the progress of science has
      led to better outcomes in the treatment of acute diseases resulting in an increase in the
      average age of the population and an increase in the number of people suffering from chronic
      diseases, even multiple, on the other the changed socio-economic conditions activities have
      led to an increase in the number of elderly and socially fragile individuals. It takes very
      little to understand that these epidemiological and socio-sanitary mutations pose a serious
      threat to the stability of the investigator's health system.

      To meet these new needs, the different countries of the world are analyzing and adopting
      various models of chronic disease management. Even if with different methodologies, all the
      models developed so far put the patient at the center of attention, in its uniqueness and
      with its needs, and propose to provide the latter with complete assistance, through the
      integration of health and social services.

      In this scenario, also the role of pharmacist, historically linked to the dispensation of
      drugs upon presentation of a medical prescription and to a final control action to ensure a
      delivery of medicines in total safety, over time has evolved. In order to carry on this
      evolution, the pharmacist has been asked for new skills, to realize what has been defined as
      "the pharmacy of services", through which the pharmacist is recognized the possibility of
      becoming a strategic figure to meet the changed needs of the population on the one hand and
      the Italian National Health System on the other and to support the latter in the transition
      from a "waiting" medicine to an "initiative" medicine.

      Diabetic disease and the resulting chronic complications, today, have a very significant
      impact on patients and their families, on morbidity and mortality, as well as having a strong
      economic impact on the health system. Despite this, most of the patients do not carry out
      what is foreseen by their diagnostic therapeutic assistance path (PDTA) due to several
      reasons such as long waiting times, the need to move to undergo examinations, which is not so
      easy for young people of working age as well as older people, lack of homogeneity in access
      to care and in the provision of services and more. The community pharmacist, therefore,
      represents, for the position in which it is located within the Italian National Health
      Service, a potential not yet considered. In fact, it could take on the role of case manager
      (a professional who manages one or more cases entrusted to him according to a pre-established
      path, such as PDTA, in a defined space-time context) of the patient suffering from type 2
      diabetes mellitus due to the capillarity territory, to the hourly availability superior to
      any other territorial health structure, to the health skills in its possession and to what it
      can offer in terms of services within the so-called "pharmacy of service".

      In this scenario, the pharmacist would not replace any of the other actors already present in
      the multidisciplinary care team but would integrate in the same and, moreover, being already
      an agreement with the Italian National Health Service, the conferral of this role would not
      cause a excessive increase in costs, such as that resulting from the hiring of new staff to
      achieve the same objectives.
observational model: Cohort
time perspective: Prospective
measure: Percent of Participants With Adherence to the PDTA
time frame: 12 months
description: Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of "pharmacy of service".
measure: Waiting Time
time frame: 365 days
description: variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)
measure: Levels of Arterial Pressure
time frame: 12 months
description: variation of arterial pressure (Systolic, Diastolic) (mmHg)
measure: Levels of HbA1c
time frame: 12 months
description: variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy
measure: Levels of LDL-cholesterol
time frame: 12 months
description: variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy
measure: Economic Impact
time frame: 12 months
description: Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the "pharmacy of service" (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)
arm group label: Group study
description: Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria).
intervention type: Other
intervention name: Follow up
description: like group descriptions
arm group label: Group study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Raffaele La Regina, dr
role: Principal Investigator
affiliation: Farmacia La Regina s.r.l.
facility: 
country: Italy
citation: Gerber BS, Rapacki L, Castillo A, Tilton J, Touchette DR, Mihailescu D, Berbaum ML, Sharp LK. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health. 2012 Oct 23;12:891. doi: 10.1186/1471-2458-12-891.
PMID: 23088168
citation: Brophy L, Williams A, Berman EJ, Keleti D, Michael KE, Shepherd M, Fox SA, Jacobs C, Tan-Torres S, Gelzer AD, Tegenu M. Collaborative DTM reduces hospitalization and healthcare costs in patients with diabetes treated with polypharmacy. Am J Manag Care. 2014 Mar 1;20(3):e72-81.
PMID: 24773329
citation: Davidson MB. The effectiveness of nurse- and pharmacist-directed care in diabetes disease management: a narrative review. Curr Diabetes Rev. 2007 Nov;3(4):280-6. doi: 10.2174/157339907782330058.
PMID: 18220688
citation: Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421.
PMID: 18363526
citation: Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction. Telemed J E Health. 2014 Feb;20(2):135-43. doi: 10.1089/tmj.2013.0145. Epub 2013 Dec 4.
PMID: 24303930
citation: Maxwell LG, McFarland MS, Baker JW, Cassidy RF. Evaluation of the Impact of a Pharmacist-Led Telehealth Clinic on Diabetes-Related Goals of Therapy in a Veteran Population. Pharmacotherapy. 2016 Mar;36(3):348-56. doi: 10.1002/phar.1719. Epub 2016 Mar 11.
PMID: 26877253
citation: Littauer SL, Dixon DL, Mishra VK, Sisson EM, Salgado TM. Pharmacists providing care in the outpatient setting through telemedicine models: a narrative review. Pharm Pract (Granada). 2017 Oct-Dec;15(4):1134. doi: 10.18549/PharmPract.2017.04.1134. Epub 2017 Dec 19.
PMID: 29317927
citation: Barr PJ, McElnay JC, Hughes CM. Connected health care: the future of health care and the role of the pharmacist. J Eval Clin Pract. 2012 Feb;18(1):56-62. doi: 10.1111/j.1365-2753.2010.01522.x. Epub 2010 Aug 4.
PMID: 20698917
citation: Hughes JD, Wibowo Y, Sunderland B, Hoti K. The role of the pharmacist in the management of type 2 diabetes: current insights and future directions. Integr Pharm Res Pract. 2017 Jan 16;6:15-27. doi: 10.2147/IPRP.S103783. eCollection 2017.
PMID: 29354547
citation: Nye AM. A Clinical Pharmacist in Telehealth Team Care for Rural Patients with Diabetes. N C Med J. 2017 May-Jun;78(3):183-184. doi: 10.18043/ncm.78.3.183. No abstract available.
PMID: 28576957
citation: Emilia Romagna region. Causes of non-adherence to the diagnostic-therapeutic treatment of diabetes mellitus: a qualitative-quantitative study for improvement - Final report. June 2018
responsible party type: Principal Investigator
investigator affiliation: Farmacia La Regina s.r.l.
investigator full name: Raffaele La Regina
investigator title: Community pharmacist
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: The data will be shared only in aggregate and anonymous form.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The monocentric nature of the study and the small number of patients, however statistically adequate, they represent limits, which can be overcome with the replication of the study on more than one wide scale.
point of contact: 