<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/NCT04503837</url>
  </required_header>
  <id_info>
    <org_study_id>HPP/CTP/RECORD/01</org_study_id>
    <nct_id>NCT04503837</nct_id>
  </id_info>
  <brief_title>Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients.</brief_title>
  <acronym>RECORD</acronym>
  <official_title>A Randomized Control Trial to Evaluate the Effectiveness of Personalized Mobile Phone Video Recording in Addition to Standard Care Compared to Standard Care Alone in Improving Inhaler Technique Among Patients With Asthma. (RECORD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penang Hospital, Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Penang Hospital, Malaysia</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>
      To investigate the effectiveness of addition of recording video of the patient performing&#xD;
      inhaler techniques using mobile phone for discussion with the patient, to standard care&#xD;
      inhaler education compared to standard care inhaler education alone, in improving inhaler&#xD;
      technique of asthma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-centre, randomized, controlled, parallel group, assessor-blinded trial to&#xD;
      evaluate the effectiveness of Personalized Mobile Phone Video Recording in addition to&#xD;
      standard care, compared to standard care alone, in improving inhaler technique among patients&#xD;
      with asthma.&#xD;
&#xD;
      Patients are randomised to either Personalized Video Recording with standard clinical&#xD;
      practice group (intervention) or to standard clinical practice group (control) in 1:1 ratio.&#xD;
&#xD;
      Subject's inhaler technique assessment is performed by using a standard checklist of steps&#xD;
      according to the type of inhaler used by subject.&#xD;
&#xD;
      All inhaler technique assessment and asthma control questionnaire will be administered before&#xD;
      the intervention/control treatment by a blinded assessor. Both intervention and control&#xD;
      treatment will be administered by the same investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All outcome assessment - inhaler technique assessment and asthma control questionnaire will be administered by a blinded assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inhaler Technique</measure>
    <time_frame>6 months</time_frame>
    <description>Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma Control</measure>
    <time_frame>1, 3 and 6 months</time_frame>
    <description>Mean score of Asthma Control Questionnaire (ACQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhaler Technique</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhaler Technique Error</measure>
    <time_frame>1, 3 and 6 months</time_frame>
    <description>Number of errors committed by patients according to checklist</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">234</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Personalized Mobile Phone Video Recording in addition to Standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Personalized Mobile Phone Video Recording</intervention_name>
    <description>Subjects will be asked to perform inhaler technique while on video recording. The video will be shown to subjects immediately during technique education session and mistakes (if any) will be pointed out to subject.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years old and above&#xD;
&#xD;
          2. Informed consent&#xD;
&#xD;
          3. Established clinical diagnosis of asthma by patient's treating doctor&#xD;
&#xD;
          4. Prescribed with inhalers (any type) for therapeutic indication for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to converse/understand Malay or English&#xD;
&#xD;
          2. Not able to perform inhalation on his/her own self&#xD;
&#xD;
          3. Using spacer/valved holding chamber in addition to MDI&#xD;
&#xD;
          4. Not able to comply with study procedures in the opinion of investigators&#xD;
&#xD;
          5. More than two different types of inhaler which require different techniques&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Choon Seong Ang, MBChB</last_name>
    <phone>0103837286</phone>
    <email>angchoonseong@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Penang General Hospital</name>
      <address>
        <city>George Town</city>
        <state>Penang</state>
        <zip>10990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <contact>
      <last_name>CHOON SEONG ANG, MBChB</last_name>
      <phone>0103837286</phone>
      <email>angchoonseong@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Irfhan Ali Hyder Ali, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chee Kin Yoon, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yen Li Lim, BPharm</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kelvin Khai Meng Beh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Choon Seong Ang, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penang Hospital, Malaysia</investigator_affiliation>
    <investigator_full_name>Choon Seong Ang</investigator_full_name>
    <investigator_title>Research Physician, Clinical Research Centre</investigator_title>
  </responsible_party>
  <keyword>inhaler technique</keyword>
  <keyword>compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04503837
org study id: HPP/CTP/RECORD/01
nct id: NCT04503837
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the effectiveness of addition of recording video of the patient performing
      inhaler techniques using mobile phone for discussion with the patient, to standard care
      inhaler education compared to standard care inhaler education alone, in improving inhaler
      technique of asthma patients.
This is a single-centre, randomized, controlled, parallel group, assessor-blinded trial to
      evaluate the effectiveness of Personalized Mobile Phone Video Recording in addition to
      standard care, compared to standard care alone, in improving inhaler technique among patients
      with asthma.

      Patients are randomised to either Personalized Video Recording with standard clinical
      practice group (intervention) or to standard clinical practice group (control) in 1:1 ratio.

      Subject's inhaler technique assessment is performed by using a standard checklist of steps
      according to the type of inhaler used by subject.

      All inhaler technique assessment and asthma control questionnaire will be administered before
      the intervention/control treatment by a blinded assessor. Both intervention and control
      treatment will be administered by the same investigators.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All outcome assessment - inhaler technique assessment and asthma control questionnaire will be administered by a blinded assessor.
measure: Inhaler Technique
time frame: 6 months
description: Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
measure: Asthma Control
time frame: 1, 3 and 6 months
description: Mean score of Asthma Control Questionnaire (ACQ)
measure: Inhaler Technique
time frame: 1 and 3 months
description: Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
measure: Inhaler Technique Error
time frame: 1, 3 and 6 months
description: Number of errors committed by patients according to checklist
arm group label: Intervention
arm group type: Experimental
description: Personalized Mobile Phone Video Recording in addition to Standard care
arm group label: Control
arm group type: No Intervention
description: Standard care alone
intervention type: Procedure
intervention name: Personalized Mobile Phone Video Recording
description: Subjects will be asked to perform inhaler technique while on video recording. The video will be shown to subjects immediately during technique education session and mistakes (if any) will be pointed out to subject.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Choon Seong Ang, MBChB
phone: 0103837286
email: angchoonseong@hotmail.com
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Penang Hospital, Malaysia
investigator full name: Choon Seong Ang
investigator title: Research Physician, Clinical Research Centre
mesh term: Asthma
sharing ipd: No