<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/NCT02203266</url>
  </required_header>
  <id_info>
    <org_study_id>RC004</org_study_id>
    <nct_id>NCT02203266</nct_id>
  </id_info>
  <brief_title>Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting</brief_title>
  <official_title>A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beaumont Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal College of Surgeons, Ireland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beaumont Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to discover whether providing feedback to patients from a device&#xD;
      that records when and how well a patient uses a Seretide Diskus inhaler will lead to:&#xD;
&#xD;
        -  Improved compliance with prescribed inhaler use&#xD;
&#xD;
        -  Improved technique of inhaler use&#xD;
&#xD;
        -  A reduction in respiratory health related outcomes caused by poor inhaler compliance and&#xD;
           usage.&#xD;
&#xD;
        -  An improvement in patient quality of life scores&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of adherence</measure>
    <time_frame>2 months and 6 months</time_frame>
    <description>The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rescue inhaled medication use</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue antibiotic and/or steroid medication use</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>2 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence in the time domain</measure>
    <time_frame>Two months and six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technique adherence</measure>
    <time_frame>Two months and six months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Asthma</condition>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Demonstration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Current best practice - inhaler technique education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care in the community pharmacy setting</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Feedback</intervention_name>
    <description>Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.</description>
    <arm_group_label>Feedback</arm_group_label>
    <other_name>INCA Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.</description>
    <arm_group_label>Demonstration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be 18 years old or above&#xD;
&#xD;
          -  Capable of understanding and willing to provide voluntary informed consent before any&#xD;
             protocol specific procedures are performed&#xD;
&#xD;
          -  Capable of understanding and complying with the requirements of the protocol, and&#xD;
             demonstrating a willingness to attend for all required visits.&#xD;
&#xD;
          -  Able and willing to take inhaled medication.&#xD;
&#xD;
          -  Have a valid prescription for use of a Seretide diskus inhaler or already using a&#xD;
             Seretide diskus inhaler.&#xD;
&#xD;
          -  Have a history of regular attendance in the pharmacy in which they are recruited which&#xD;
             will be demonstrated by the subject having collected three prescriptions for any&#xD;
             medication in that pharmacy in the six months preceeding their recruitment to the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient expressly reports that their physician has indicated that they will not be&#xD;
             continuing to receive Seretide over the next 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Costello, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boots Retail (Ireland) Limited</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beaumont Hospital</investigator_affiliation>
    <investigator_full_name>Professor Richard Costello</investigator_full_name>
    <investigator_title>Professor Richard Costello</investigator_title>
  </responsible_party>
  <keyword>Medication Adherence</keyword>
  <keyword>Patient Compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02203266
org study id: RC004
nct id: NCT02203266
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this trial is to discover whether providing feedback to patients from a device
      that records when and how well a patient uses a Seretide Diskus inhaler will lead to:

        -  Improved compliance with prescribed inhaler use

        -  Improved technique of inhaler use

        -  A reduction in respiratory health related outcomes caused by poor inhaler compliance and
           usage.

        -  An improvement in patient quality of life scores
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of adherence
time frame: 2 months and 6 months
description: The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.
measure: Rescue inhaled medication use
time frame: Six months
measure: Rescue antibiotic and/or steroid medication use
time frame: 6 months
measure: Quality of life
time frame: 2 months and 6 months
measure: Adherence in the time domain
time frame: Two months and six months
measure: Technique adherence
time frame: Two months and six months
arm group label: Feedback
arm group type: Experimental
description: Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.
arm group label: Demonstration
arm group type: Active Comparator
description: Current best practice - inhaler technique education
arm group label: Control
arm group type: No Intervention
description: Usual care in the community pharmacy setting
intervention type: Device
intervention name: Feedback
description: Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.
arm group label: Feedback
other name: INCA Device
intervention type: Behavioral
intervention name: Education
description: Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.
arm group label: Demonstration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Costello, Professor
role: Principal Investigator
affiliation: Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: Beaumont Hospital
investigator full name: Professor Richard Costello
investigator title: Professor Richard Costello
mesh term: Pulmonary Disease, Chronic Obstructive