<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/NCT02189616</url>
  </required_header>
  <id_info>
    <org_study_id>xjhx-song2</org_study_id>
    <nct_id>NCT02189616</nct_id>
  </id_info>
  <brief_title>Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control</brief_title>
  <official_title>Evaluate the Clinical Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on the Self-management and Outcomes of Poorly-controlled Asthma: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baoji Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hanzhong Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yan'an University Affiliated Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Asthma is the disease being studied. The main objective of this study is to assess the&#xD;
      clinical efficacy of mobile phone short message service (SMS) reminder and consultation on&#xD;
      the self-management and outcomes of poorly controlled asthma which is first diagnosed in a&#xD;
      time period of 3 months. The secondary objective is to explore the cost-benefit and&#xD;
      cost-effectiveness of the proposed intervention.&#xD;
&#xD;
      Aims: The main aim of this study is to assist asthma patients to practice asthma&#xD;
      self-management at home by sending reminders and responding to patients' consultations with&#xD;
      mobile phone short message service (SMS), which will eventually help them to control their&#xD;
      asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to&#xD;
      improve patient health outcome via enhancing patient-physician interaction through mobile&#xD;
      phone short message service (SMS) that is low-cost and could be followed easily by the&#xD;
      patients and their physicians.&#xD;
&#xD;
      The hypothesis is that asthma patients who receive weekly text message reminders to educate&#xD;
      them and reinforce adherence will have better asthma outcome, such as asthma control, while&#xD;
      the intervention integrating patient consultation and reminders by SMS improve asthma outcome&#xD;
      even more. The investigators further hypothesize that these subjects under intervention will&#xD;
      have an improvement in secondary measures including quality of life and patient satisfaction.&#xD;
      The investigators also anticipate that such an approach in asthma management will be&#xD;
      cost-effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After examined for their eligibility and recruited into this study at outpatient service, all&#xD;
      participants have their case records which contain their baseline data and receive the same&#xD;
      standard asthma education(including basic knowledge about asthma, how to use their medicine,&#xD;
      what to do when an asthma attack happens and when to come back for their disease review and&#xD;
      so on). Each patient is given a paper asthma diary and a peak expiratory flow(PEF) measurer&#xD;
      for free. In addition, they are told what intervention they will receive and revised&#xD;
      face-to-face one month after the beginning of intervention. After the 3-month study period,&#xD;
      when they return to the hospitals, they will return the asthma diaries, be asked to fill in&#xD;
      the questionnaires and take pulmonary function tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>
  </study_design_info>
  <primary_outcome>
    <measure>change in asthma control measured by Asthma Control Test(ACT)</measure>
    <time_frame>3 months</time_frame>
    <description>change in asthma control measured by Asthma Control Test(ACT) between baseline and 3 months after randomization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)</measure>
    <time_frame>3 months</time_frame>
    <description>score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) at baseline and 3 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini-asthma quality of life questionnaire (mini-AQLQ)</measure>
    <time_frame>3 months</time_frame>
    <description>mini-AQLQ scores at baseline and 3 months after the randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>asthma control</measure>
    <time_frame>3 months</time_frame>
    <description>change of asthma control level indicated by symptom score, PEF and asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing) from baseline to the end of intervention(3 months)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>cost effectiveness</measure>
    <time_frame>3 months</time_frame>
    <description>The cost effectiveness of SMS reminder and consultation interventions compared to controls without study interventions.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>regular care group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>receive regular care which contains filling a paper asthma diary daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS reminder group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receive weekly mobile phone short message reminders for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS reminder and SMS consultation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receive weekly mobile phone short message reminders and can consult asthma nurse by mobile phone short message when needed for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS reminder</intervention_name>
    <description>send weekly mobile phone short message reminders to the intervention group</description>
    <arm_group_label>SMS reminder and SMS consultation group</arm_group_label>
    <arm_group_label>SMS reminder group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS consultation</intervention_name>
    <description>told patients to consult qualified asthma nurses by SMS when they need</description>
    <arm_group_label>SMS reminder and SMS consultation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>regular care</intervention_name>
    <description>patients are asked to fill in their paper asthma diary daily for 3 months</description>
    <arm_group_label>SMS reminder and SMS consultation group</arm_group_label>
    <arm_group_label>SMS reminder group</arm_group_label>
    <arm_group_label>regular care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Physician diagnosed uncontrolled or partly-controlled asthma by Global Initiative for&#xD;
             Asthma(GINA) standard.&#xD;
&#xD;
          2. At least 6 months asthma history.&#xD;
&#xD;
          3. Ownership of a mobile phone and currently using the text messaging service.&#xD;
&#xD;
          4. Age between 18 and 65 years old.&#xD;
&#xD;
          5. Willingness to participate in this study.&#xD;
&#xD;
          6. Willing to sign the written informed consent to take part in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to provide written informed consent or to fill in the paper asthma diary.&#xD;
&#xD;
          2. A history of smoking cigarettes for greater than ten pack years.&#xD;
&#xD;
          3. Other current or a history of severe comorbidity.&#xD;
&#xD;
          4. Being in other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>liqiang song, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>first affiliated hospital, the fourth military medical university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juan Wang, master</last_name>
    <phone>18909233806</phone>
    <email>ddys1211@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhikui li, doctor</last_name>
      <phone>13571855922</phone>
      <email>lizhikui@fmmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>liqiang song, doctor</last_name>
      <phone>13991160546</phone>
      <email>songlq@fmmu.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Xiaofan Hu, Bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>liqiang song, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>songlq</investigator_full_name>
    <investigator_title>vice director of department of respirotary and critical care medine</investigator_title>
  </responsible_party>
  <keyword>asthma management</keyword>
  <keyword>SMS reminder</keyword>
  <keyword>SMS consultation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT02189616
org study id: xjhx-song2
nct id: NCT02189616
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Asthma is the disease being studied. The main objective of this study is to assess the
      clinical efficacy of mobile phone short message service (SMS) reminder and consultation on
      the self-management and outcomes of poorly controlled asthma which is first diagnosed in a
      time period of 3 months. The secondary objective is to explore the cost-benefit and
      cost-effectiveness of the proposed intervention.

      Aims: The main aim of this study is to assist asthma patients to practice asthma
      self-management at home by sending reminders and responding to patients' consultations with
      mobile phone short message service (SMS), which will eventually help them to control their
      asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to
      improve patient health outcome via enhancing patient-physician interaction through mobile
      phone short message service (SMS) that is low-cost and could be followed easily by the
      patients and their physicians.

      The hypothesis is that asthma patients who receive weekly text message reminders to educate
      them and reinforce adherence will have better asthma outcome, such as asthma control, while
      the intervention integrating patient consultation and reminders by SMS improve asthma outcome
      even more. The investigators further hypothesize that these subjects under intervention will
      have an improvement in secondary measures including quality of life and patient satisfaction.
      The investigators also anticipate that such an approach in asthma management will be
      cost-effective.
After examined for their eligibility and recruited into this study at outpatient service, all
      participants have their case records which contain their baseline data and receive the same
      standard asthma education(including basic knowledge about asthma, how to use their medicine,
      what to do when an asthma attack happens and when to come back for their disease review and
      so on). Each patient is given a paper asthma diary and a peak expiratory flow(PEF) measurer
      for free. In addition, they are told what intervention they will receive and revised
      face-to-face one month after the beginning of intervention. After the 3-month study period,
      when they return to the hospitals, they will return the asthma diaries, be asked to fill in
      the questionnaires and take pulmonary function tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change in asthma control measured by Asthma Control Test(ACT)
time frame: 3 months
description: change in asthma control measured by Asthma Control Test(ACT) between baseline and 3 months after randomization.
measure: score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)
time frame: 3 months
description: score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) at baseline and 3 months
measure: Mini-asthma quality of life questionnaire (mini-AQLQ)
time frame: 3 months
description: mini-AQLQ scores at baseline and 3 months after the randomization
measure: asthma control
time frame: 3 months
description: change of asthma control level indicated by symptom score, PEF and asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing) from baseline to the end of intervention(3 months)
measure: cost effectiveness
time frame: 3 months
description: The cost effectiveness of SMS reminder and consultation interventions compared to controls without study interventions.
arm group label: regular care group
arm group type: Other
description: receive regular care which contains filling a paper asthma diary daily.
arm group label: SMS reminder group
arm group type: Experimental
description: receive weekly mobile phone short message reminders for 3 months
arm group label: SMS reminder and SMS consultation group
arm group type: Experimental
description: receive weekly mobile phone short message reminders and can consult asthma nurse by mobile phone short message when needed for 3 months
intervention type: Behavioral
intervention name: SMS reminder
description: send weekly mobile phone short message reminders to the intervention group
arm group label: SMS reminder and SMS consultation group
arm group label: SMS reminder group
intervention type: Other
intervention name: SMS consultation
description: told patients to consult qualified asthma nurses by SMS when they need
arm group label: SMS reminder and SMS consultation group
intervention type: Other
intervention name: regular care
description: patients are asked to fill in their paper asthma diary daily for 3 months
arm group label: SMS reminder and SMS consultation group
arm group label: SMS reminder group
arm group label: regular care group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: liqiang song, doctor
role: Principal Investigator
affiliation: first affiliated hospital, the fourth military medical university
last name: Juan Wang, master
phone: 18909233806
email: ddys1211@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: songlq
investigator title: vice director of department of respirotary and critical care medine
mesh term: Asthma