<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/NCT02213809</url>
  </required_header>
  <id_info>
    <org_study_id>2013/232-31/5</org_study_id>
    <nct_id>NCT02213809</nct_id>
  </id_info>
  <brief_title>Case Method Education on COPD to General Practitioners</brief_title>
  <acronym>PRIMAIR</acronym>
  <official_title>Effect of Case Method Education to General Practitioners on Their Knowledge on COPD and on the Health of Their Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dalarna County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most&#xD;
      patients with COPD are discovered and treated in primary health care. Co-morbidity with heart&#xD;
      disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to&#xD;
      diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most&#xD;
      important factor for decelerating the progress of COPD. In addition, medication and&#xD;
      rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown&#xD;
      poor quality of primary health care provided to patients with COPD.&#xD;
&#xD;
      As general practitioners often deal with multiple medical problems and patients' motivation&#xD;
      when diagnosing and treating COPD we hypothesize that case method education (see description&#xD;
      under &quot;intervention&quot;) in COPD has better effect than traditional education (see description&#xD;
      under &quot;intervention&quot;).This study aims to examine the effect of case method education on (1)&#xD;
      learning in COPD among general practitioners and on (2) health in their patients with COPD.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be&#xD;
      randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs)&#xD;
      in COPD for their general practitioners. The educations will be held during two times (two&#xD;
      hours each) within a time range of three months, covering examination and treatment of&#xD;
      patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random&#xD;
      sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will&#xD;
      fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as&#xD;
      well as questions about medication, exacerbations and other chronic diseases. The&#xD;
      questionnaire will be sent to the patients 1-2 months before the education and 18 months&#xD;
      after the education. Differences in assessments in the questionnaire before and after the&#xD;
      education will be compared between the patients listed at the PHCCs that have received case&#xD;
      method education vs. traditional education. In addition, general practitioners&#xD;
      (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12&#xD;
      months after the education, covering the learning outcomes in order to study differences in&#xD;
      learning between the two intervention groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2014</start_date>
  <completion_date type="Actual">December 12, 2018</completion_date>
  <primary_completion_date type="Actual">December 12, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later.</measure>
    <time_frame>1-2 months before the intervention and 18 months after the intervention</time_frame>
    <description>The CCQ measures health status in patients with COPD and consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). All scores range from 0 to 6; (0 = no impairment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education.</measure>
    <time_frame>Immediately before the intervention and 12 months later.</time_frame>
    <description>The questionnaire covers examination and treatment of COPD and includes multiple choice questions as well as questions about attitudes that will be answered in free text.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference i patients' assessment of Lung Information Needs Questionnaire (LINQ) before the intervention and 18 months later.</measure>
    <time_frame>1-2 months before the intervention and 18 months after the intervention</time_frame>
    <description>LINQ measures patients perceptions about COPD and what information about COPD patients think that they have percieved from health care personnel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in patients' assessment of COPD Assessment Test (CAT) before the intervention and 18 months later.</measure>
    <time_frame>1-2 months before the intervention and 18 months after the intervention</time_frame>
    <description>The COPD Assessment Test (CAT) measures the impact of COPD on a person's life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">822</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Case method education in COPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two hours of case method education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers. The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional education in COPD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two hours of traditional education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers.The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Case method education in COPD</intervention_name>
    <description>In case method a rich narrative describing of a real-life situation (teaching case) is presented, in which the learning group must make a decision or solve a problem. The teaching case provide information, but neither analysis nor conclusions. The analytical work of explaining the relationships among events in the case, identifying options, evaluating choices and predicting the effects of actions is the work done by students during the discussion.</description>
    <arm_group_label>Case method education in COPD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Traditional education in COPD</intervention_name>
    <description>Traditional education in this study means that the teacher mainly speaks to the group. Although short cases may be used for illustration, the main focus is not that the group shall solve problems from a narrative case.</description>
    <arm_group_label>Traditional education in COPD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary Health Care Centers (PHCC): &gt;10.000 patients listed. &gt;70% permanent employed&#xD;
             general practitioners&#xD;
&#xD;
          -  Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the&#xD;
             latest spirometry completed since 2008.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Nager, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanna Sandelowsky, MD</last_name>
    <role>Study Director</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Family Medicine, NVS, Karolinska Institutet</name>
      <address>
        <city>Huddinge</city>
        <zip>141 83</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Anna Nager</investigator_full_name>
    <investigator_title>Senior lecturer and general practitioner</investigator_title>
  </responsible_party>
  <!-- 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/NCT02213809
org study id: 2013/232-31/5
nct id: NCT02213809
lead sponsor: 
collaborator: 
has dmc: No
Background:

      COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most
      patients with COPD are discovered and treated in primary health care. Co-morbidity with heart
      disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to
      diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most
      important factor for decelerating the progress of COPD. In addition, medication and
      rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown
      poor quality of primary health care provided to patients with COPD.

      As general practitioners often deal with multiple medical problems and patients' motivation
      when diagnosing and treating COPD we hypothesize that case method education (see description
      under "intervention") in COPD has better effect than traditional education (see description
      under "intervention").This study aims to examine the effect of case method education on (1)
      learning in COPD among general practitioners and on (2) health in their patients with COPD.

      Method:

      Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be
      randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs)
      in COPD for their general practitioners. The educations will be held during two times (two
      hours each) within a time range of three months, covering examination and treatment of
      patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random
      sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will
      fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as
      well as questions about medication, exacerbations and other chronic diseases. The
      questionnaire will be sent to the patients 1-2 months before the education and 18 months
      after the education. Differences in assessments in the questionnaire before and after the
      education will be compared between the patients listed at the PHCCs that have received case
      method education vs. traditional education. In addition, general practitioners
      (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12
      months after the education, covering the learning outcomes in order to study differences in
      learning between the two intervention groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later.
time frame: 1-2 months before the intervention and 18 months after the intervention
description: The CCQ measures health status in patients with COPD and consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). All scores range from 0 to 6; (0 = no impairment).
measure: Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education.
time frame: Immediately before the intervention and 12 months later.
description: The questionnaire covers examination and treatment of COPD and includes multiple choice questions as well as questions about attitudes that will be answered in free text.
measure: Difference i patients' assessment of Lung Information Needs Questionnaire (LINQ) before the intervention and 18 months later.
time frame: 1-2 months before the intervention and 18 months after the intervention
description: LINQ measures patients perceptions about COPD and what information about COPD patients think that they have percieved from health care personnel.
measure: Difference in patients' assessment of COPD Assessment Test (CAT) before the intervention and 18 months later.
time frame: 1-2 months before the intervention and 18 months after the intervention
description: The COPD Assessment Test (CAT) measures the impact of COPD on a person's life.
arm group label: Case method education in COPD
arm group type: Experimental
description: Two hours of case method education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers. The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education.
arm group label: Traditional education in COPD
arm group type: Active Comparator
description: Two hours of traditional education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers.The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education.
intervention type: Behavioral
intervention name: Case method education in COPD
description: In case method a rich narrative describing of a real-life situation (teaching case) is presented, in which the learning group must make a decision or solve a problem. The teaching case provide information, but neither analysis nor conclusions. The analytical work of explaining the relationships among events in the case, identifying options, evaluating choices and predicting the effects of actions is the work done by students during the discussion.
arm group label: Case method education in COPD
intervention type: Behavioral
intervention name: Traditional education in COPD
description: Traditional education in this study means that the teacher mainly speaks to the group. Although short cases may be used for illustration, the main focus is not that the group shall solve problems from a narrative case.
arm group label: Traditional education in COPD
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Anna Nager, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Hanna Sandelowsky, MD
role: Study Director
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Anna Nager
investigator title: Senior lecturer and general practitioner