<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/NCT01692119</url>
  </required_header>
  <id_info>
    <org_study_id>PHARM-CHF</org_study_id>
    <nct_id>NCT01692119</nct_id>
  </id_info>
  <brief_title>Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure</brief_title>
  <acronym>PHARM-CHF</acronym>
  <official_title>Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal Union of German Associations of Pharmacists</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universität des Saarlandes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal Union of German Associations of Pharmacists</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate whether a continuous interdisciplinary intervention&#xD;
      improves medication adherence (primary efficacy endpoint) and leads to a reduction of&#xD;
      hospitalizations and mortality (primary safety endpoint) in elderly patients with chronic&#xD;
      heart failure. The intervention, consisting of regular contacts with the local pharmacy and&#xD;
      weekly dosing aids, aims to improve medication adherence and management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of days covered (PDC) by prescribed medication and according to claims data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause</measure>
    <time_frame>12 months</time_frame>
    <description>Days lost due to unplanned cardiovascular hospitalizations or death of any cause</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>regular, pharmacy-based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>providing medication in weekly dosing aids and regular contacts with the local pharmacy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Regular, pharmacy based intervention</intervention_name>
    <description>Regular, pharmacy-based intervention conducted in cooperation with the treating physician:&#xD;
Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.&#xD;
Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.</description>
    <arm_group_label>regular, pharmacy-based intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 60 years and older&#xD;
&#xD;
          -  Chronic heart failure (CHF)&#xD;
&#xD;
          -  Stable CHF medication including a diuretic&#xD;
&#xD;
          -  Hospitalization for decompensated heart failure within past 12 months OR a value of ≥&#xD;
             350 pg/mL for BNP or ≥ 1,400 pg/mL for NT-proBNP&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of a weekly dosing aid&#xD;
&#xD;
          -  Unwillingness or inability to visit a participating pharmacy once a week&#xD;
&#xD;
          -  Planned cardiac surgery&#xD;
&#xD;
          -  Life-expectancy &lt; 6 months&#xD;
&#xD;
          -  Unwillingness or inability to comply with the study protocol (including drug abuse or&#xD;
             alcohol dependency)&#xD;
&#xD;
          -  Participation in other studies (currently or in the last 4 weeks)&#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>Martin Schulz, Prof. PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Federal Union of German Associations of Pharmacists</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulrich Laufs, Prof. MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitätsklinikum Leipzig</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saarland University</name>
      <address>
        <city>Homburg/Saar</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.pharm-chf.de</url>
    <description>PHARM-CHF study home page</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>March 2, 2021</results_first_submitted>
  <results_first_submitted_qc>March 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 26, 2021</results_first_posted>
  <last_update_submitted>March 25, 2021</last_update_submitted>
  <last_update_submitted_qc>March 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic heart failure</keyword>
  <keyword>medication adherence</keyword>
  <keyword>pharmacy</keyword>
  <keyword>interdisciplinary care</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>mortality</keyword>
  <keyword>hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT01692119/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT01692119/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Regular, Pharmacy-based Intervention</title>
          <description>providing medication in weekly dosing aids and regular contacts with the local pharmacy&#xD;
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:&#xD;
Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.&#xD;
Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Intervention: pts. did not present to participating pharmacy</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Regular, Pharmacy-based Intervention</title>
          <description>providing medication in weekly dosing aids and regular contacts with the local pharmacy&#xD;
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:&#xD;
Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.&#xD;
Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="110"/>
            <count group_id="B2" value="127"/>
            <count group_id="B3" value="237"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="110"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.1" spread="6.8"/>
                    <measurement group_id="B2" value="74.1" spread="7.2"/>
                    <measurement group_id="B3" value="74.1" spread="7.0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="110"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Medication Adherence</title>
        <description>Percentage of days covered (PDC) by prescribed medication and according to claims data</description>
        <time_frame>12 months</time_frame>
        <population>Patients for whom we were able to calculate a PDC.</population>
        <group_list>
          <group group_id="O1">
            <title>Regular, Pharmacy-based Intervention</title>
            <description>providing medication in weekly dosing aids and regular contacts with the local pharmacy&#xD;
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:&#xD;
Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.&#xD;
Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Adherence</title>
          <description>Percentage of days covered (PDC) by prescribed medication and according to claims data</description>
          <population>Patients for whom we were able to calculate a PDC.</population>
          <units>percentage of days covered</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2" spread="11.9"/>
                    <measurement group_id="O2" value="85.5" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause</title>
        <description>Days lost due to unplanned cardiovascular hospitalizations or death of any cause</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Regular, Pharmacy-based Intervention</title>
            <description>providing medication in weekly dosing aids and regular contacts with the local pharmacy&#xD;
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:&#xD;
Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.&#xD;
Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause</title>
          <description>Days lost due to unplanned cardiovascular hospitalizations or death of any cause</description>
          <units>days lost</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.8" lower_limit="10.6" upper_limit="38.9"/>
                    <measurement group_id="O2" value="16.5" lower_limit="6.1" upper_limit="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>365 days and until end of the study</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Regular, Pharmacy-based Intervention</title>
          <description>providing medication in weekly dosing aids and regular contacts with the local pharmacy&#xD;
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:&#xD;
Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.&#xD;
Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
              </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="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
              </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>Dr. Martin Schulz</name_or_title>
      <organization>ABDA, Department of Medicine</organization>
      <phone>+49 30 40004-514</phone>
      <email>arzneimittel@abda.de</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/NCT01692119
org study id: PHARM-CHF
nct id: NCT01692119
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of the study is to investigate whether a continuous interdisciplinary intervention
      improves medication adherence (primary efficacy endpoint) and leads to a reduction of
      hospitalizations and mortality (primary safety endpoint) in elderly patients with chronic
      heart failure. The intervention, consisting of regular contacts with the local pharmacy and
      weekly dosing aids, aims to improve medication adherence and management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Medication Adherence
time frame: 12 months
description: Percentage of days covered (PDC) by prescribed medication and according to claims data
measure: Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause
time frame: 12 months
description: Days lost due to unplanned cardiovascular hospitalizations or death of any cause
arm group label: regular, pharmacy-based intervention
arm group type: Experimental
description: providing medication in weekly dosing aids and regular contacts with the local pharmacy
arm group label: usual care
arm group type: No Intervention
description: usual care
intervention type: Behavioral
intervention name: Regular, pharmacy based intervention
description: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.
arm group label: regular, pharmacy-based intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Schulz, Prof. PhD
role: Study Chair
affiliation: Federal Union of German Associations of Pharmacists
last name: Ulrich Laufs, Prof. MD
role: Study Chair
affiliation: Universitätsklinikum Leipzig
facility: 
country: Germany
url: http://www.pharm-chf.de
description: PHARM-CHF study home page
responsible party type: Sponsor
mesh term: Heart Failure
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 