<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/NCT02222181</url>
  </required_header>
  <id_info>
    <org_study_id>24947914.5.0000.5426</org_study_id>
    <nct_id>NCT02222181</nct_id>
  </id_info>
  <brief_title>Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease</brief_title>
  <official_title>Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual Paulista Júlio de Mesquita Filho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Estadual Paulista Júlio de Mesquita Filho</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Brazil, patients with Alzheimer's disease (AD) receiving free drugs of government. Even&#xD;
      having access to, little is known about the effectiveness, safety and adherence of drug&#xD;
      therapy in this group of patients. The research aims to promote adherence and develop&#xD;
      strategies to address Drug-Related Problems (DRP's) in AD patients elderly of reference&#xD;
      centre for the Elderly of Araraquara. The clinical parameters will be assessed at the&#xD;
      beginning and after the educational intervention period from April 2014 to April 2015.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dementia is characterized by memory loss associated with cognitive impairment, which directly&#xD;
      interferes in learning process, social and professional performance, besides being the main&#xD;
      cause of dementia or Alzheimer's disease (AD). In Brazil, patients are medicated for AD&#xD;
      through &quot;Programa de Medicamentos Excepcionais&quot; (Exceptional Drug Program) that ensure the&#xD;
      patient´s treatment by providing high cost medications. Even having access to, little is&#xD;
      known about the effectiveness, safety and adherence of drug therapy in this group of&#xD;
      patients. The research aims to promote adherence and develop strategies to address&#xD;
      Drug-Related Problems (DRP's) in AD patients. For this end, we intend to conduct a&#xD;
      descriptive, almost experimental and longitudinal uncontrolled research, from April 2014 to&#xD;
      December 2015, at the CRIA: &quot;Centro de Referência do Idoso de Araraquara&quot; (Reference Centre&#xD;
      for the Elderly of Araraquara). Patients included in the research must have a diagnosis of AD&#xD;
      and must be using drugs supplied by the &quot;Programa de Medicamentos Excepcionais&quot;. For data&#xD;
      collection pharmaceutical care will be employed as a technique, carried out through&#xD;
      pharmaceutical meetings, including the steps of initial assessment, care plan (pharmaceutical&#xD;
      intervention) and results evaluation. The results will be monitored for pharmacotherapy&#xD;
      adherence, cognitive assessment and other clinical parameters related to their health&#xD;
      problems and resolution of DRP's before and after the proposed follow-up.The expected&#xD;
      outcomes include knowledge of the medication experiences of AD patients, how they influence&#xD;
      the adherence and other DRP's and how they can contribute by solving these problems, in&#xD;
      addition to the impact evaluation of pharmaceutical care in cognitive improving and other&#xD;
      clinical parameters monitored and evaluated individually.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mini-mental State Examination (MMEE)</measure>
    <time_frame>six months</time_frame>
    <description>MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Dementia Rating (CDR)</measure>
    <time_frame>six months</time_frame>
    <description>CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>weekly</time_frame>
    <description>Systolic pressure &lt;140 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>Total Cholesterol</time_frame>
    <description>Total Cholesterol &lt;200 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>three months</time_frame>
    <description>Normal level: 150mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemia</measure>
    <time_frame>two months</time_frame>
    <description>Normal levels: 70-99mg/dL; diabetic: &gt;121mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>weekly</time_frame>
    <description>Diastolic pressure &lt;90 mmHg</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Pharmacotherapy follow-up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with Alzheimer's disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacotherapy Management</intervention_name>
    <description>assessment of patient characteristics as alcoholic, smoker, food, drugs&#xD;
Pharmacotherapy follow-up&#xD;
to evaluated medication adherence&#xD;
Assessment of the individual clinical parameters each patient at baseline and after the educational or pharmacy intervention.</description>
    <arm_group_label>Pharmacotherapy follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly patients who are assisted in CRIA, diagnosed with Alzheimer's in use of&#xD;
             rivastigmine or donepezil or galantamine, assisted by the &quot;Program for special drugs&quot;.&#xD;
&#xD;
          -  Be resident in the city of Araraquara / SP&#xD;
&#xD;
          -  Accept part of pharmacotherapeutic follow-up;&#xD;
&#xD;
          -  Sign the Statement of Informed Consent Form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fold over pharmacotherapy follow-up;&#xD;
&#xD;
          -  Being institutionalized;&#xD;
&#xD;
          -  Patients unable to respond to collection instruments MMSE and CDR data;&#xD;
&#xD;
          -  Patient without phone contact.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernanda M Oliveira, student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Referência do Idoso de Araraquara - CRIA</name>
      <address>
        <city>Araraquara</city>
        <state>São Paulo</state>
        <zip>14800240</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Strand LM, Cipolle RJ, Morley PC. Documenting the clinical pharmacist's activities: back to basics. Drug Intell Clin Pharm. 1988 Jan;22(1):63-7. doi: 10.1177/106002808802200116.</citation>
    <PMID>3349924</PMID>
  </reference>
  <reference>
    <citation>Arlt S, Lindner R, Rosler A, von Renteln-Kruse W. Adherence to medication in patients with dementia: predictors and strategies for improvement. Drugs Aging. 2008;25(12):1033-47. doi: 10.2165/0002512-200825120-00005.</citation>
    <PMID>19021302</PMID>
  </reference>
  <reference>
    <citation>Lanctot KL, Herrmann N, Yau KK, Khan LR, Liu BA, LouLou MM, Einarson TR. Efficacy and safety of cholinesterase inhibitors in Alzheimer's disease: a meta-analysis. CMAJ. 2003 Sep 16;169(6):557-64.</citation>
    <PMID>12975222</PMID>
  </reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <results_first_submitted>April 3, 2016</results_first_submitted>
  <results_first_submitted_qc>April 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 6, 2016</results_first_posted>
  <last_update_submitted>April 3, 2016</last_update_submitted>
  <last_update_submitted_qc>April 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</investigator_affiliation>
    <investigator_full_name>Fernanda Mariana de Oliveira</investigator_full_name>
    <investigator_title>Master's degree student</investigator_title>
  </responsible_party>
  <keyword>elderly, medication adherence,pharmaceutical care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Experimental, longitudinal and non-randomized study, carried out at Centro de Referência do Idoso de Araraquara (CRIA), from 2014 april to 2015 april, with patients in treatment for Alzheimer's disease.</recruitment_details>
      <pre_assignment_details>Patients were excluded when in advanced or terminal stage of the disease, lived in nursing homes and when it was not possible to contact the patient.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pharmacotherapy Follow-up</title>
          <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>patients in treatment for Alzheimer's disease.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </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="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mini-mental State Examination (MMEE)</title>
        <description>MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)</description>
        <time_frame>six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pharmacotherapy Follow-up</title>
            <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Mini-mental State Examination (MMEE)</title>
          <description>MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)</description>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.23</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Dementia Rating (CDR)</title>
        <description>CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)</description>
        <time_frame>six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pharmacotherapy Follow-up</title>
            <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Dementia Rating (CDR)</title>
          <description>CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)</description>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure</title>
        <description>Systolic pressure &lt;140 mmHg</description>
        <time_frame>weekly</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pharmacotherapy Follow-up</title>
            <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <description>Systolic pressure &lt;140 mmHg</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.6" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.7" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Cholesterol</title>
        <description>Total Cholesterol &lt;200 mg/dL</description>
        <time_frame>Total Cholesterol</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pharmacotherapy Follow-up</title>
            <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Cholesterol</title>
          <description>Total Cholesterol &lt;200 mg/dL</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="202.2" spread="41.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187.6" spread="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Triglycerides</title>
        <description>Normal level: 150mg/dL</description>
        <time_frame>three months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pharmacotherapy Follow-up</title>
            <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Triglycerides</title>
          <description>Normal level: 150mg/dL</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.1" spread="63.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.8" spread="48.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemia</title>
        <description>Normal levels: 70-99mg/dL; diabetic: &gt;121mg/dL.</description>
        <time_frame>two months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pharmacotherapy Follow-up</title>
            <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemia</title>
          <description>Normal levels: 70-99mg/dL; diabetic: &gt;121mg/dL.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.9" spread="57.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.9" spread="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure</title>
        <description>Diastolic pressure &lt;90 mmHg</description>
        <time_frame>weekly</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pharmacotherapy Follow-up</title>
            <description>All the patients received pharmacotherapy workup at baseline and after the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <description>Diastolic pressure &lt;90 mmHg</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.49" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.03" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Do not apply.</time_frame>
      <desc>Do not apply.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>Do not apply.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="55"/>
              </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>
    <point_of_contact>
      <name_or_title>Fernanda Mariana de Oliveira</name_or_title>
      <organization>Unesp</organization>
      <phone>+551636640217</phone>
      <email>femoliveira12@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/NCT02222181
org study id: 24947914.5.0000.5426
nct id: NCT02222181
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In Brazil, patients with Alzheimer's disease (AD) receiving free drugs of government. Even
      having access to, little is known about the effectiveness, safety and adherence of drug
      therapy in this group of patients. The research aims to promote adherence and develop
      strategies to address Drug-Related Problems (DRP's) in AD patients elderly of reference
      centre for the Elderly of Araraquara. The clinical parameters will be assessed at the
      beginning and after the educational intervention period from April 2014 to April 2015.
Dementia is characterized by memory loss associated with cognitive impairment, which directly
      interferes in learning process, social and professional performance, besides being the main
      cause of dementia or Alzheimer's disease (AD). In Brazil, patients are medicated for AD
      through "Programa de Medicamentos Excepcionais" (Exceptional Drug Program) that ensure the
      patient´s treatment by providing high cost medications. Even having access to, little is
      known about the effectiveness, safety and adherence of drug therapy in this group of
      patients. The research aims to promote adherence and develop strategies to address
      Drug-Related Problems (DRP's) in AD patients. For this end, we intend to conduct a
      descriptive, almost experimental and longitudinal uncontrolled research, from April 2014 to
      December 2015, at the CRIA: "Centro de Referência do Idoso de Araraquara" (Reference Centre
      for the Elderly of Araraquara). Patients included in the research must have a diagnosis of AD
      and must be using drugs supplied by the "Programa de Medicamentos Excepcionais". For data
      collection pharmaceutical care will be employed as a technique, carried out through
      pharmaceutical meetings, including the steps of initial assessment, care plan (pharmaceutical
      intervention) and results evaluation. The results will be monitored for pharmacotherapy
      adherence, cognitive assessment and other clinical parameters related to their health
      problems and resolution of DRP's before and after the proposed follow-up.The expected
      outcomes include knowledge of the medication experiences of AD patients, how they influence
      the adherence and other DRP's and how they can contribute by solving these problems, in
      addition to the impact evaluation of pharmaceutical care in cognitive improving and other
      clinical parameters monitored and evaluated individually.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Mini-mental State Examination (MMEE)
time frame: six months
description: MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)
measure: Clinical Dementia Rating (CDR)
time frame: six months
description: CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)
measure: Systolic Blood Pressure
time frame: weekly
description: Systolic pressure <140 mmHg
measure: Total Cholesterol
time frame: Total Cholesterol
description: Total Cholesterol <200 mg/dL
measure: Triglycerides
time frame: three months
description: Normal level: 150mg/dL
measure: Glycemia
time frame: two months
description: Normal levels: 70-99mg/dL; diabetic: >121mg/dL.
measure: Diastolic Blood Pressure
time frame: weekly
description: Diastolic pressure <90 mmHg
arm group label: Pharmacotherapy follow-up
arm group type: Experimental
description: patients with Alzheimer's disease
intervention type: Other
intervention name: Pharmacotherapy Management
description: assessment of patient characteristics as alcoholic, smoker, food, drugs
Pharmacotherapy follow-up
to evaluated medication adherence
Assessment of the individual clinical parameters each patient at baseline and after the educational or pharmacy intervention.
arm group label: Pharmacotherapy follow-up
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Fernanda M Oliveira, student
role: Principal Investigator
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
facility: 
country: Brazil
citation: Strand LM, Cipolle RJ, Morley PC. Documenting the clinical pharmacist's activities: back to basics. Drug Intell Clin Pharm. 1988 Jan;22(1):63-7. doi: 10.1177/106002808802200116.
PMID: 3349924
citation: Arlt S, Lindner R, Rosler A, von Renteln-Kruse W. Adherence to medication in patients with dementia: predictors and strategies for improvement. Drugs Aging. 2008;25(12):1033-47. doi: 10.2165/0002512-200825120-00005.
PMID: 19021302
citation: Lanctot KL, Herrmann N, Yau KK, Khan LR, Liu BA, LouLou MM, Einarson TR. Efficacy and safety of cholinesterase inhibitors in Alzheimer's disease: a meta-analysis. CMAJ. 2003 Sep 16;169(6):557-64.
PMID: 12975222
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
investigator full name: Fernanda Mariana de Oliveira
investigator title: Master's degree student
mesh term: Alzheimer Disease
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 