<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/NCT03277664</url>
  </required_header>
  <id_info>
    <org_study_id>ESR-15-11001</org_study_id>
    <nct_id>NCT03277664</nct_id>
  </id_info>
  <brief_title>Electronic Monitoring Combined With Weekly Feedback and Reminders</brief_title>
  <official_title>The Effect of Electronic Monitoring Combined With Weekly Feedback and Reminders on Adherence to Inhaled Corticosteroids in Infants and Younger Children With Asthma: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Children's Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A total of 96 recruited children (aged 6 months to 3 years) with mild or moderate persistent&#xD;
      asthma who were on regular inhaled corticosteroids (ICS) were randomly allocated to receive&#xD;
      electronic monitoring combined with instant messaging software -based weekly feeding back&#xD;
      adherence and reminders to keep taking the ICS (intervention group) and to receive electronic&#xD;
      monitoring only (control group). The device-monitored adherence rates and caregiver-reported&#xD;
      adherence rates were analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">January 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The Study of Asthma Adherence study was a multicentre, single-blind, parallel group randomised controlled trial, with an allocation ratio of 1:1.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Due to the nature of the intervention, the caregivers of the participants and follow-up nurse were not blinded. But the doctors and statisticians were blinded. Both in the intervention group and control group, adherence data were not available to clinicians.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>device monitored adherence rate</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The primary outcome of the study was change in the adherence rate monitored by the electronic device for 6 consecutive months. This adherence rate was calculated as the number of device recorded times /number of total times prescribed × 100%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>caregiver-reported adherence rate</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The secondary outcomes for the study were the caregiver-reported adherence rate and the difference between device-monitored and caregiver-reported adherence rates for 6 consecutive months. The caregiver-reported adherence rate was recorded on a monthly basis. It was offered by the caregivers of patients through answering the questions &quot;Has our child inhaled the medicine according to the doctor's instructions&quot; and &quot;How about the frequency&quot;. The device-monitored and caregiver-reported adherence rates were compared monthly.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly &quot;Has our child inhaled the medicine according to the doctor's instructions?&quot; and &quot;How about the frequency?&quot; by telephone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All the device-monitored adherence data were downloaded from the background database and calculated weekly. However, feedback and reminders were not given to the caregivers. Caregivers were also asked monthly &quot;Has our child inhaled the medicine according to the doctor's instructions?&quot; and &quot;How about the frequency?&quot; by telephone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>intervention group</intervention_name>
    <description>All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly &quot;Has our child inhaled the medicine according to the doctor's instructions?&quot; and &quot;How about the frequency?&quot; by telephone.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients having mild or moderate persistent asthma&#xD;
&#xD;
          2. 6 months-3 years&#xD;
&#xD;
          3. taking regular inhaled steroids, with no change in their medication in the last month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who had severe persistent asthma or another respiratory disease or did not&#xD;
        live in Shanghai were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai children's medical center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>November 1, 2019</last_update_submitted>
  <last_update_submitted_qc>November 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>asthma adherence</keyword>
  <keyword>electronic device</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/NCT03277664
org study id: ESR-15-11001
nct id: NCT03277664
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A total of 96 recruited children (aged 6 months to 3 years) with mild or moderate persistent
      asthma who were on regular inhaled corticosteroids (ICS) were randomly allocated to receive
      electronic monitoring combined with instant messaging software -based weekly feeding back
      adherence and reminders to keep taking the ICS (intervention group) and to receive electronic
      monitoring only (control group). The device-monitored adherence rates and caregiver-reported
      adherence rates were analyzed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The Study of Asthma Adherence study was a multicentre, single-blind, parallel group randomised controlled trial, with an allocation ratio of 1:1.
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: Due to the nature of the intervention, the caregivers of the participants and follow-up nurse were not blinded. But the doctors and statisticians were blinded. Both in the intervention group and control group, adherence data were not available to clinicians.
measure: device monitored adherence rate
time frame: up to 6 months
description: The primary outcome of the study was change in the adherence rate monitored by the electronic device for 6 consecutive months. This adherence rate was calculated as the number of device recorded times /number of total times prescribed × 100%.
measure: caregiver-reported adherence rate
time frame: up to 6 months
description: The secondary outcomes for the study were the caregiver-reported adherence rate and the difference between device-monitored and caregiver-reported adherence rates for 6 consecutive months. The caregiver-reported adherence rate was recorded on a monthly basis. It was offered by the caregivers of patients through answering the questions "Has our child inhaled the medicine according to the doctor's instructions" and "How about the frequency". The device-monitored and caregiver-reported adherence rates were compared monthly.
arm group label: intervention group
arm group type: Experimental
description: All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly "Has our child inhaled the medicine according to the doctor's instructions?" and "How about the frequency?" by telephone.
arm group label: control group
arm group type: No Intervention
description: All the device-monitored adherence data were downloaded from the background database and calculated weekly. However, feedback and reminders were not given to the caregivers. Caregivers were also asked monthly "Has our child inhaled the medicine according to the doctor's instructions?" and "How about the frequency?" by telephone.
intervention type: Behavioral
intervention name: intervention group
description: All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly "Has our child inhaled the medicine according to the doctor's instructions?" and "How about the frequency?" by telephone.
arm group label: intervention group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 3 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No