<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/NCT02990117</url>
  </required_header>
  <id_info>
    <org_study_id>ESR-16-12138</org_study_id>
    <nct_id>NCT02990117</nct_id>
  </id_info>
  <brief_title>ICS Treatment Compliance of Asthma Patients</brief_title>
  <official_title>An In-depth Understanding of Determinants of Inhaled ICS Treatment Compliance of Asthma Patients: Generate Data From Structured Patient Interview &amp; Cross Sectional Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The introduction of inhaled medication as the primary treatment for asthma has led to&#xD;
      substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still&#xD;
      common and represents a considerable burden to patients and society [3, 4]. An important&#xD;
      reason for poor asthma control and consequently, increased healthcare expenditure is&#xD;
      suboptimal adherence to the prescribed regimen [5-7].&#xD;
&#xD;
      Real-world market research study in hospitals across China reported that physicians perceived&#xD;
      that only 23% of patients were fully compliant with their medication regime (77%&#xD;
      non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal&#xD;
      document]. The physician reported rate of full adherence was lower than the patient-reported&#xD;
      rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of&#xD;
      physicians) when treating an asthma.[8]&#xD;
&#xD;
      However&#xD;
&#xD;
      There is some evidence on the drivers of patient behaviour around low adherence but more&#xD;
      depth research is needed&#xD;
&#xD;
      There is little evidence on variation of determinants of asthma inhaled treatment across&#xD;
      different age of group&#xD;
&#xD;
      Our research aims to address above data gap Mean while this research can guide the&#xD;
      development of new module on Red Scarf patient education program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study site(s) and number of subjects planned 8 level-3 hospitals across West China will&#xD;
      participate in this study. 40 not well controlled asthma patients will participate the&#xD;
      structured interview in stage1 and a total number of 300 patients are expected to participate&#xD;
      cross sectional survey in stage 2.&#xD;
&#xD;
      Study period Estimated Time CSP approved Oct. 2016 First subject in Jan. 2017 Last subject in&#xD;
      Aug. 2017 Database lock Dec. 2017 CSR Mar. 2017&#xD;
&#xD;
      Study design It is study including 2 stage, stage 1 of structured patient interview by&#xD;
      investigators, Stage 2 of a multi-center, cross-sectional survey. 40 eligible asthma patients&#xD;
      and/or their family supporter will be invited to participate in a one-time face to face&#xD;
      structured interview in stage 1. Around 350 eligible asthma patients will be invited to&#xD;
      participate in cross sectional survey which all Information and relevant data of their&#xD;
      compliance to inhaled treatment therapy and response to measurement of compliance risk&#xD;
      factors (determinants explored from stage 1) will be collected according to CRF, and inputted&#xD;
      into an on-line electronic questionnaire data capture (EDC) system by site investigator(s),&#xD;
      and valid data will be taken into statistical analyses.&#xD;
&#xD;
      Target subject population Stage 1: Asthmatic patients with in adequate asthma control&#xD;
      (defined by GINA partly or un-control due to inhaled treatment compliance (physician&#xD;
      judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by&#xD;
      investigator.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      Stage 1:&#xD;
&#xD;
      Primary Objective: Outcome Measure:&#xD;
&#xD;
      Non- Assumptive Deep Dive Qualitative Scoping to investigate determinants of poor adherence&#xD;
      to ICS treatment through structured interview &amp; taskforce workshop Decide key measures for&#xD;
      phase2 survey through steering committee group review. Categorized &quot;risk factors&quot; (patient&#xD;
      behavior/belief, social status, medical care availability etc.) which very likely led to poor&#xD;
      patient adherence on inhaled treatment adherence in partly or uncontrolled asthma patients&#xD;
&#xD;
        1. Therapy related factors&#xD;
&#xD;
        2. Patient related factors&#xD;
&#xD;
        3. Provider related factors&#xD;
&#xD;
        4. Disease related factors&#xD;
&#xD;
        5. Practice and system related factors&#xD;
&#xD;
      Questionnaire with measures for asthma patient adherence determinants in survey on stage 2&#xD;
&#xD;
      Stage 2:&#xD;
&#xD;
      Primary Objective: Outcome Measure:&#xD;
&#xD;
      To investigate the relationship different risk factors (determinants explored from stage 1)&#xD;
      and treatment adherence to further identify top 5 determinants most closely relative to&#xD;
      inhalation treatment adherence&#xD;
&#xD;
      Decide key measures for phase2 survey through steering committee group review. Asthma patient&#xD;
      compliance level on Inhaled treatment (ICS or ICS/LABA) by using validated MARS-A scale&#xD;
      questionnaire below.&#xD;
&#xD;
      Risk factors (determinants explored from stage 1) measurements response from asthma patients&#xD;
&#xD;
      Secondary Objective: Outcome Measure :&#xD;
&#xD;
      Similar objectives on deferent life-stage group of asthma patients. Similar analysis by&#xD;
      different life-stage group of patients (18- 30, 31-45,45-60, 60+)&#xD;
&#xD;
      Statistical methods&#xD;
&#xD;
        -  All results will be described. In general, the descriptive statistics (number, mean, and&#xD;
           median, standard deviation, minimum and maximum) will be presented for continuous&#xD;
           variables. The frequency and percentage of subjects at each level or category will be&#xD;
           presented for categorical variables. Where appropriate, 95% confidence intervals will be&#xD;
           constructed.&#xD;
&#xD;
        -  Risk factor analysis will be performed using univariate and multivariate regression&#xD;
           model to explore the relationship between risk factors and the compliance level. In&#xD;
           addition to multivariate analysis using all variables, a step-wise variable selection&#xD;
           can be used. The level of both variable inclusion and exclusion will be set as 0.15. The&#xD;
           important variable (s) can be forced in the model if applicable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">January 20, 2018</completion_date>
  <primary_completion_date type="Actual">January 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MARS-A scale</measure>
    <time_frame>Mar.2017-Dec,2017</time_frame>
    <description>MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk factors (determinants explored from stage 1) measurements response from asthma patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MARS-A scale of group patients age in 18- 30, age in 31-45, age in 45-60, age above 60</measure>
    <time_frame>Mar.2017-Dec,2017</time_frame>
    <description>MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk facto rs measurements response from asthma patients</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">350</enrollment>
  <condition>Asthma, Allergic</condition>
  <arm_group>
    <arm_group_label>Asthmatic patient</arm_group_label>
    <description>Asthma patients aged &gt;18 in out-patient clinic of the first affiliated hospital of Xi'an Jiaotong university from November 2016 to January 2018 were investigated. A two-stage study was applied which was non-assumptive deep dive qualitative scoping to investigate the determinants of poor compliance in stage 1 asthma patients, and developed new questionnaire for cross sectional survey in stage 2 to obtain more accurate information about the critical issues on asthma management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>No Intervention</description>
    <arm_group_label>Asthmatic patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stage 1: Asthmatic patients with in adequate asthma control (defined by GINA partly or&#xD;
        un-control due to inhaled treatment compliance (physician judgement) Stage 2: Asthmatic&#xD;
        patient who visit the outpatient clinic will be interviewed by investigator.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criterias:&#xD;
&#xD;
          1. Age ≥18 years old&#xD;
&#xD;
          2. Living in the city same as the study site for a minimum period of two years&#xD;
&#xD;
          3. Having China city residence medical insurance&#xD;
&#xD;
          4. A history of at least one year of diagnosed asthma who should be on ICS or ICS/LABA&#xD;
             inhalation treatment based on the criteria established by GINA.&#xD;
&#xD;
          5. Patients On inhaled ICS or ICS/LABA treatment regard less of compliance level in the&#xD;
             past 6 months&#xD;
&#xD;
          6. Subjects who are willing to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with active cardio or pulmonary disease such as bronchiectasis, COPD, cystic&#xD;
             fibrosis, pulmonary tuberculosis, lung cancer, severe heart disease, etc.; other&#xD;
             disorder such as HIV/AIDS, etc; or therapy that according to the physician could&#xD;
             interfere with the aim of the study.&#xD;
&#xD;
          2. Patients with mental or neurological diseases, or due to alcohol or other drug abuse,&#xD;
             that may be incapable to understand and answer the question honestly, or unwilling to&#xD;
             do so.&#xD;
&#xD;
          3. Other conditions judged by investigator as unsuitable for this study&#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_official>
    <last_name>Manxiang Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital Xi'an Jiaotong University</investigator_affiliation>
    <investigator_full_name>Li Manxiang</investigator_full_name>
    <investigator_title>Director, Respiratory department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02990117
org study id: ESR-16-12138
nct id: NCT02990117
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The introduction of inhaled medication as the primary treatment for asthma has led to
      substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still
      common and represents a considerable burden to patients and society [3, 4]. An important
      reason for poor asthma control and consequently, increased healthcare expenditure is
      suboptimal adherence to the prescribed regimen [5-7].

      Real-world market research study in hospitals across China reported that physicians perceived
      that only 23% of patients were fully compliant with their medication regime (77%
      non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal
      document]. The physician reported rate of full adherence was lower than the patient-reported
      rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of
      physicians) when treating an asthma.[8]

      However

      There is some evidence on the drivers of patient behaviour around low adherence but more
      depth research is needed

      There is little evidence on variation of determinants of asthma inhaled treatment across
      different age of group

      Our research aims to address above data gap Mean while this research can guide the
      development of new module on Red Scarf patient education program.
Study site(s) and number of subjects planned 8 level-3 hospitals across West China will
      participate in this study. 40 not well controlled asthma patients will participate the
      structured interview in stage1 and a total number of 300 patients are expected to participate
      cross sectional survey in stage 2.

      Study period Estimated Time CSP approved Oct. 2016 First subject in Jan. 2017 Last subject in
      Aug. 2017 Database lock Dec. 2017 CSR Mar. 2017

      Study design It is study including 2 stage, stage 1 of structured patient interview by
      investigators, Stage 2 of a multi-center, cross-sectional survey. 40 eligible asthma patients
      and/or their family supporter will be invited to participate in a one-time face to face
      structured interview in stage 1. Around 350 eligible asthma patients will be invited to
      participate in cross sectional survey which all Information and relevant data of their
      compliance to inhaled treatment therapy and response to measurement of compliance risk
      factors (determinants explored from stage 1) will be collected according to CRF, and inputted
      into an on-line electronic questionnaire data capture (EDC) system by site investigator(s),
      and valid data will be taken into statistical analyses.

      Target subject population Stage 1: Asthmatic patients with in adequate asthma control
      (defined by GINA partly or un-control due to inhaled treatment compliance (physician
      judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by
      investigator.

      Objectives

      Stage 1:

      Primary Objective: Outcome Measure:

      Non- Assumptive Deep Dive Qualitative Scoping to investigate determinants of poor adherence
      to ICS treatment through structured interview & taskforce workshop Decide key measures for
      phase2 survey through steering committee group review. Categorized "risk factors" (patient
      behavior/belief, social status, medical care availability etc.) which very likely led to poor
      patient adherence on inhaled treatment adherence in partly or uncontrolled asthma patients

        1. Therapy related factors

        2. Patient related factors

        3. Provider related factors

        4. Disease related factors

        5. Practice and system related factors

      Questionnaire with measures for asthma patient adherence determinants in survey on stage 2

      Stage 2:

      Primary Objective: Outcome Measure:

      To investigate the relationship different risk factors (determinants explored from stage 1)
      and treatment adherence to further identify top 5 determinants most closely relative to
      inhalation treatment adherence

      Decide key measures for phase2 survey through steering committee group review. Asthma patient
      compliance level on Inhaled treatment (ICS or ICS/LABA) by using validated MARS-A scale
      questionnaire below.

      Risk factors (determinants explored from stage 1) measurements response from asthma patients

      Secondary Objective: Outcome Measure :

      Similar objectives on deferent life-stage group of asthma patients. Similar analysis by
      different life-stage group of patients (18- 30, 31-45,45-60, 60+)

      Statistical methods

        -  All results will be described. In general, the descriptive statistics (number, mean, and
           median, standard deviation, minimum and maximum) will be presented for continuous
           variables. The frequency and percentage of subjects at each level or category will be
           presented for categorical variables. Where appropriate, 95% confidence intervals will be
           constructed.

        -  Risk factor analysis will be performed using univariate and multivariate regression
           model to explore the relationship between risk factors and the compliance level. In
           addition to multivariate analysis using all variables, a step-wise variable selection
           can be used. The level of both variable inclusion and exclusion will be set as 0.15. The
           important variable (s) can be forced in the model if applicable.
observational model: Other
time perspective: Cross-Sectional
measure: MARS-A scale
time frame: Mar.2017-Dec,2017
description: MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk factors (determinants explored from stage 1) measurements response from asthma patients
measure: MARS-A scale of group patients age in 18- 30, age in 31-45, age in 45-60, age above 60
time frame: Mar.2017-Dec,2017
description: MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk facto rs measurements response from asthma patients
arm group label: Asthmatic patient
description: Asthma patients aged >18 in out-patient clinic of the first affiliated hospital of Xi'an Jiaotong university from November 2016 to January 2018 were investigated. A two-stage study was applied which was non-assumptive deep dive qualitative scoping to investigate the determinants of poor compliance in stage 1 asthma patients, and developed new questionnaire for cross sectional survey in stage 2 to obtain more accurate information about the critical issues on asthma management.
intervention type: Other
intervention name: No Intervention
description: No Intervention
arm group label: Asthmatic patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manxiang Li, PhD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital Xi'an Jiaotong University
investigator full name: Li Manxiang
investigator title: Director, Respiratory department
mesh term: Asthma
sharing ipd: Undecided