<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/NCT02967588</url>
  </required_header>
  <id_info>
    <org_study_id>v1 06-09-16</org_study_id>
    <nct_id>NCT02967588</nct_id>
  </id_info>
  <brief_title>An Intervention to Support Medication Adherence Following Acute Coronary Syndrome</brief_title>
  <official_title>Development and Feasibility of a Brief Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal&#xD;
      and is associated with poor clinical outcomes. Non-adherence can be considered intentional or&#xD;
      unintentional. Findings ways to improve adherence is an important area of research with&#xD;
      widespread clinical implications, however, previous interventions have generally been&#xD;
      ineffective. The investigators propose an intervention that challenges both intentional and&#xD;
      unintentional non-adherence in patients hospitalised following ACS.&#xD;
&#xD;
      Objectives The objective of this study is to determine the feasibility of a hospital-based&#xD;
      intervention aimed at supporting medication adherence in patients following an ACS.&#xD;
&#xD;
      Methods Patients admitted to hospital with an ACS will be recruited for this study. The study&#xD;
      will target both intentional and unintentional non-adherence over two sessions through&#xD;
      challenging treatment beliefs and formulating specific action plans to encourage habit&#xD;
      formation. Patients will be asked to provide in-depth feedback around the acceptability of&#xD;
      the intervention. As this is a feasibility study, outcomes (i.e. medication adherence) will&#xD;
      not be collected.&#xD;
&#xD;
      Dissemination If this study seems to be practical to deliver and acceptable to patients then&#xD;
      it will inform the design of a future randomized-controlled pilot study to test the&#xD;
      effectiveness of the intervention delivered by hospital pharmacists on a study outcome (i.e.&#xD;
      medication adherence).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention details&#xD;
&#xD;
        -  All stages of the intervention will take place during hospitalization.&#xD;
&#xD;
        -  Firstly, patients will complete a questionnaire based on the Beliefs about Medication&#xD;
           Questionnaire-Specific (BMQ-S) (Horne &amp; Weinmen, 1999).&#xD;
&#xD;
        -  Patients responses to this questionnaire will form the basis of Session 1 where beliefs&#xD;
           about medicines will be discussed. The aim is to identify any negative or erroneous&#xD;
           beliefs patients have that may prevent them from taking their medicines after they leave&#xD;
           the hospital.&#xD;
&#xD;
        -  Session 2 will focus on developing specific action plans for taking medication at home.&#xD;
           Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I&#xD;
           am doing Z, then I will take my pill dose'. The aim is to make taking their medicines as&#xD;
           much a part of their daily routine as possible.&#xD;
&#xD;
        -  Prior to discharge, patients will complete the beliefs questionnaire again to see if&#xD;
           there has been any shift in their beliefs about medications.&#xD;
&#xD;
        -  Patients will also be asked to provide detailed feedback about the study. The&#xD;
           investigators want to know whether the intervention setting (i.e. hospital-based),&#xD;
           timing (i.e. straight after an ACS), content (i.e. targeting both intentional and&#xD;
           unintentional non-adherence) and interventionist (i.e. PhD candidate) seem to be&#xD;
           acceptable to patients.&#xD;
&#xD;
        -  Feedback will be gathered after completion of the intervention and also during a follow&#xD;
           up phone call 2-3 weeks after discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment beliefs</measure>
    <time_frame>During index hospitalisation, within two days of admission.</time_frame>
    <description>Beliefs about medications will be compared pre-post intervention using responses from the BMQ-S, Separate necessity and concerns scores will be calculated (5-items each, total scores ranging 5-25) along with the BMQ differential (necessity score - concerns score) (Gujral et al., 2014).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Initial patient study feedback</measure>
    <time_frame>During index hospitalisation, within two days of admission.</time_frame>
    <description>Patients will complete a study feedback questionnaire which will determine its acceptability to patients (setting, timing, content, delivery method).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detailed patient study feedback</measure>
    <time_frame>Within three weeks post-discharge</time_frame>
    <description>Detailed patient feedback will be gathered 2-3 weeks after discharge via a phone call. A brief semi-structured interview will be undertaken and study acceptability will be assessed (setting, timing, content, delivery method). The follow up call will be audio recorded, transcribed and used to evaluate the intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention group</intervention_name>
    <description>All stages of the intervention will take place during hospitalization. Patients will complete a questionnaire about their personal beliefs about medicines. Patients responses to this questionnaire will form the basis of Session 1 where beliefs about medicines will be discussed. Any negative beliefs or concerns will be discussed and beliefs about drug necessity will be encouraged.&#xD;
Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose').&#xD;
Prior to discharge, patients will complete the beliefs questionnaire again to see if there has been any shift in their beliefs about medications. Patients will also be asked to provide detailed feedback about the study. The investigators want to know whether the intervention setting, timing, content and delivery method seem to be acceptable to patients.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of ACS&#xD;
&#xD;
          -  ACS primary reason for hospitalization&#xD;
&#xD;
          -  Patients to be prescribed medications for secondary prevention (i.e. antiplatelet&#xD;
             drugs, statins, ACEi, ARBs, β-blockers)&#xD;
&#xD;
          -  Sufficient spoken English to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Developed ACS as a secondary condition (i.e. perioperative MI)&#xD;
&#xD;
          -  Not prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins,&#xD;
             ACEi, ARBs, β-blockers)&#xD;
&#xD;
          -  Non-English speaking&#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>Guy's and St Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>June 30, 2017</last_update_submitted>
  <last_update_submitted_qc>June 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medication adherence</keyword>
  <keyword>Behavioural intervention</keyword>
  <keyword>Acute coronary syndrome</keyword>
  <keyword>Medication beliefs</keyword>
  <keyword>Implementation intentions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 18, 2019</submitted>
    <returned>October 10, 2019</returned>
  </pending_results>
  <!-- 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/NCT02967588
org study id: v1 06-09-16
nct id: NCT02967588
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal
      and is associated with poor clinical outcomes. Non-adherence can be considered intentional or
      unintentional. Findings ways to improve adherence is an important area of research with
      widespread clinical implications, however, previous interventions have generally been
      ineffective. The investigators propose an intervention that challenges both intentional and
      unintentional non-adherence in patients hospitalised following ACS.

      Objectives The objective of this study is to determine the feasibility of a hospital-based
      intervention aimed at supporting medication adherence in patients following an ACS.

      Methods Patients admitted to hospital with an ACS will be recruited for this study. The study
      will target both intentional and unintentional non-adherence over two sessions through
      challenging treatment beliefs and formulating specific action plans to encourage habit
      formation. Patients will be asked to provide in-depth feedback around the acceptability of
      the intervention. As this is a feasibility study, outcomes (i.e. medication adherence) will
      not be collected.

      Dissemination If this study seems to be practical to deliver and acceptable to patients then
      it will inform the design of a future randomized-controlled pilot study to test the
      effectiveness of the intervention delivered by hospital pharmacists on a study outcome (i.e.
      medication adherence).
Intervention details

        -  All stages of the intervention will take place during hospitalization.

        -  Firstly, patients will complete a questionnaire based on the Beliefs about Medication
           Questionnaire-Specific (BMQ-S) (Horne & Weinmen, 1999).

        -  Patients responses to this questionnaire will form the basis of Session 1 where beliefs
           about medicines will be discussed. The aim is to identify any negative or erroneous
           beliefs patients have that may prevent them from taking their medicines after they leave
           the hospital.

        -  Session 2 will focus on developing specific action plans for taking medication at home.
           Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I
           am doing Z, then I will take my pill dose'. The aim is to make taking their medicines as
           much a part of their daily routine as possible.

        -  Prior to discharge, patients will complete the beliefs questionnaire again to see if
           there has been any shift in their beliefs about medications.

        -  Patients will also be asked to provide detailed feedback about the study. The
           investigators want to know whether the intervention setting (i.e. hospital-based),
           timing (i.e. straight after an ACS), content (i.e. targeting both intentional and
           unintentional non-adherence) and interventionist (i.e. PhD candidate) seem to be
           acceptable to patients.

        -  Feedback will be gathered after completion of the intervention and also during a follow
           up phone call 2-3 weeks after discharge.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment beliefs
time frame: During index hospitalisation, within two days of admission.
description: Beliefs about medications will be compared pre-post intervention using responses from the BMQ-S, Separate necessity and concerns scores will be calculated (5-items each, total scores ranging 5-25) along with the BMQ differential (necessity score - concerns score) (Gujral et al., 2014).
measure: Initial patient study feedback
time frame: During index hospitalisation, within two days of admission.
description: Patients will complete a study feedback questionnaire which will determine its acceptability to patients (setting, timing, content, delivery method).
measure: Detailed patient study feedback
time frame: Within three weeks post-discharge
description: Detailed patient feedback will be gathered 2-3 weeks after discharge via a phone call. A brief semi-structured interview will be undertaken and study acceptability will be assessed (setting, timing, content, delivery method). The follow up call will be audio recorded, transcribed and used to evaluate the intervention.
arm group label: Intervention
arm group type: Experimental
intervention type: Behavioral
intervention name: Intervention group
description: All stages of the intervention will take place during hospitalization. Patients will complete a questionnaire about their personal beliefs about medicines. Patients responses to this questionnaire will form the basis of Session 1 where beliefs about medicines will be discussed. Any negative beliefs or concerns will be discussed and beliefs about drug necessity will be encouraged.
Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose').
Prior to discharge, patients will complete the beliefs questionnaire again to see if there has been any shift in their beliefs about medications. Patients will also be asked to provide detailed feedback about the study. The investigators want to know whether the intervention setting, timing, content and delivery method seem to be acceptable to patients.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No
submitted: September 18, 2019
returned: October 10, 2019