<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/NCT01684176</url>
  </required_header>
  <id_info>
    <org_study_id>AKF-381</org_study_id>
    <nct_id>NCT01684176</nct_id>
  </id_info>
  <brief_title>Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication</brief_title>
  <official_title>Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk&#xD;
      of a new stroke, however, poor adherence to secondary prevention medications occurs&#xD;
      frequently within this patient group. The purpose of this study is to evaluate whether a&#xD;
      complex tailored pharmacist intervention will lead to increased adherence to secondary stroke&#xD;
      prevention medications and less new stroke events when compared to a usual care group.&#xD;
      Interventions focus on motivational interviewing, medication review and telephone follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).</measure>
    <time_frame>One year from inclusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC&gt;0.8)</measure>
    <time_frame>1 year from inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence to antihypertensives measured by proportion of days covered (PDC)</measure>
    <time_frame>One year from inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of patients that are at least 80% adherent (PDC&gt;0.8) to antihypertensives</measure>
    <time_frame>One year from inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-persistence with thromboprophylactic agents ( antiplatelets, anticoagulants, statins and antihypertensives) measured by percent of patients that are not supplied with medication for more than 3 continuous months</measure>
    <time_frame>One year from inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.</measure>
    <time_frame>3 months from discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite endpoint: stroke, myocardial infarction or cardiovascular death</measure>
    <time_frame>One year from inclusion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Stroke</condition>
  <condition>Transient Ischemic Attack</condition>
  <arm_group>
    <arm_group_label>Complex tailored intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consists of 3 elements:&#xD;
Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications.&#xD;
Discharge consultation with an pharmacist using motivational interviewing techniques.&#xD;
Follow-up telephone calls one week, two months and six months after discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Complex tailored intervention</intervention_name>
    <arm_group_label>Complex tailored intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Complex tailored intervention</arm_group_label>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years or older&#xD;
&#xD;
          -  Patient admitted or receiving ambulatory treatment for an acute transient ischemic&#xD;
             attack or ischemic stroke which has occurred within the previous 30 days.&#xD;
&#xD;
          -  The patient or a carer usually dispenses the patient's medications&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive or physical impairment that would preclude comprehension of a conversation&#xD;
&#xD;
          -  Terminal illness&#xD;
&#xD;
          -  Lives in a care home or an institution&#xD;
&#xD;
          -  Receives dose dispensed medicine from a pharmacy&#xD;
&#xD;
          -  Medicine is dispensed by a nurse in the patient's home&#xD;
&#xD;
          -  Correctional mental health patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Hedegaard U, Kjeldsen LJ, Pottegard A, Bak S, Hallas J. Multifaceted intervention including motivational interviewing to support medication adherence after stroke/transient ischemic attack: a randomized trial. Cerebrovasc Dis Extra. 2014 Dec 11;4(3):221-34. doi: 10.1159/000369380. eCollection 2014 Sep-Dec.</citation>
    <PMID>25598772</PMID>
  </reference>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>January 19, 2015</last_update_submitted>
  <last_update_submitted_qc>January 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Ulla Hedegaard</investigator_full_name>
    <investigator_title>PhD student, MSc (pharm)</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Ischemic Attack, Transient</keyword>
  <keyword>Medication adherence</keyword>
  <keyword>Motivational interviewing</keyword>
  <keyword>Stroke prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Attack, Transient</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684176
org study id: AKF-381
nct id: NCT01684176
lead sponsor: 
collaborator: 
has dmc: No
Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk
      of a new stroke, however, poor adherence to secondary prevention medications occurs
      frequently within this patient group. The purpose of this study is to evaluate whether a
      complex tailored pharmacist intervention will lead to increased adherence to secondary stroke
      prevention medications and less new stroke events when compared to a usual care group.
      Interventions focus on motivational interviewing, medication review and telephone follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).
time frame: One year from inclusion
measure: For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)
time frame: 1 year from inclusion
measure: Medication Adherence to antihypertensives measured by proportion of days covered (PDC)
time frame: One year from inclusion
measure: Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives
time frame: One year from inclusion
measure: Non-persistence with thromboprophylactic agents ( antiplatelets, anticoagulants, statins and antihypertensives) measured by percent of patients that are not supplied with medication for more than 3 continuous months
time frame: One year from inclusion
measure: Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.
time frame: 3 months from discharge
measure: Composite endpoint: stroke, myocardial infarction or cardiovascular death
time frame: One year from inclusion
arm group label: Complex tailored intervention
arm group type: Experimental
description: The intervention consists of 3 elements:
Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications.
Discharge consultation with an pharmacist using motivational interviewing techniques.
Follow-up telephone calls one week, two months and six months after discharge.
arm group label: Usual care
arm group type: Placebo Comparator
description: Usual care
intervention type: Behavioral
intervention name: Complex tailored intervention
arm group label: Complex tailored intervention
intervention type: Behavioral
intervention name: Usual care
arm group label: Complex tailored intervention
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
citation: Hedegaard U, Kjeldsen LJ, Pottegard A, Bak S, Hallas J. Multifaceted intervention including motivational interviewing to support medication adherence after stroke/transient ischemic attack: a randomized trial. Cerebrovasc Dis Extra. 2014 Dec 11;4(3):221-34. doi: 10.1159/000369380. eCollection 2014 Sep-Dec.
PMID: 25598772
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Ulla Hedegaard
investigator title: PhD student, MSc (pharm)
mesh term: Stroke
mesh term: Ischemic Attack, Transient