<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/NCT03762330</url>
  </required_header>
  <id_info>
    <org_study_id>P17/055</org_study_id>
    <nct_id>NCT03762330</nct_id>
  </id_info>
  <brief_title>Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in COPD Patients</brief_title>
  <official_title>Effect of a Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in People With Chronic Obstructive Pulmonary Disease(COPD). A Randomised Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut Catala de Salut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</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>
      This study evaluates the effect of of a structured self-management intervention plan in&#xD;
      patients with chronic obstructive pulmonary disease in primary care setting.Half of the&#xD;
      participants will receive the self-management plan while the other half will receive usual&#xD;
      care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with&#xD;
      an associated increased mortality and a high cost (consumption of health care resources and&#xD;
      loss of health related quality of life (HRQoL)). The comprehensive approach to this complex&#xD;
      disease, focusing self-care promotion, improves HRQoL and the patients&quot; clinical status, as&#xD;
      shown by several studies, although further investigation is needed to confirm these results&#xD;
      in the field of Primary Care (PC) and to formulate clear recommendations on the more&#xD;
      effective type of intervention.&#xD;
&#xD;
      Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention&#xD;
      plan in the setting of primary care, is more effective than usual treatment on the main&#xD;
      outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital&#xD;
      admissions, at 6, 12 and 24 months of follow-up.&#xD;
&#xD;
      Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care&#xD;
      and improve HRQoL in people with COPD in PC.&#xD;
&#xD;
      Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona.&#xD;
&#xD;
      Determinations: Specific standardized and validated questionnaires, as the St George's&#xD;
      Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive&#xD;
      statistics of the variables of the intervention and the control group to assess their&#xD;
      homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to&#xD;
      assess differences among intervention groups.&#xD;
&#xD;
      Expected results: A significant improvement in HRQoL attributable to the intervention&#xD;
      performed in patients with COPD Applicability and Relevance: To implement the intervention&#xD;
      plan in clinical practice and to standardize its content.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life St. George´s Respiratory Questionnaire (SGRQ)</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>St. George´s Respiratory Questionnaire (SGRQ).Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.&#xD;
Number of items: 50 items Number of domains &amp; categories : 2 parts (3 components). Part 1 : Symptoms component (frequency &amp; severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.&#xD;
Scaling of items Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale). Scores range from 0 to 100, with higher scores indicating more limitations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity of symptoms related to COPD</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>COPD Assessment Test (CAT) : It consists of 8 questions with 5 possible answers valued from 0 to 5 (values close to 0: better health status)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea score severity</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>Dyspnea severity assessed by the modified scale of the Medical Research Council (mMRC). Range 0-4 (none to maximum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index )</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>Index including BMI (Body mass index), Obstruction, Dyspnea, Exacerbations. with possible answers from 0-3, each item. Range: 0-9. Mild: 0-2 Moderate: 3-4 Severe ≥5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of COPD exacerbations</measure>
    <time_frame>at 6 ,12 and 24 months from baseline</time_frame>
    <description>Number of COPD exacerbations requiring a visit to primary care physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions due to COPD exacerbation</measure>
    <time_frame>at 6 ,12 and 24 months from baseline</time_frame>
    <description>Number of hospital admissions due to COPD exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Anxiety and depression scales</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>Goldberg's anxiety-depression scale (GADS): is an 18-item self-report symptom inventory that was developed by Goldberg and colleagues from 36 items in the Psychiatric Assessment Schedule. The GADS score is based on responses of 'yes' or 'no' to nine depression and nine anxiety items, asking how respondents have been feeling in the past month. Goldberg et al. (1988) considered patients with anxiety scores of 5 or more or with depression scores of 2 or more as having a 50% chance of a clinically important disturbance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced vital capacity (FVC)</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>Value of FVC measured with forced spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced expiratory volume at the first second (FEV1)</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>Value of FEV1 measured with forced spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of the Test of Adherence to Inhalers (TAI test)</measure>
    <time_frame>Change from baseline at 6 ,12 and 24 months</time_frame>
    <description>TAI test. Includes 10 questions self-completed by patient. Range of each questions; 1worse compliance and 5 best compliance. The total score of the 10 items gives a total from 1-50.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of long-acting beta-adrenergic bronchodilator in monotherapy</measure>
    <time_frame>At baseline and at 6 ,12 and 24 months</time_frame>
    <description>Use of long-acting beta-adrenergic bronchodilator in monotherapy (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of long-acting anticholinergic bronchodilator in monotherapy</measure>
    <time_frame>At baseline and at 6 ,12 and 24 months</time_frame>
    <description>Use of long-acting anticholinergic bronchodilator in monotherapy (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator</measure>
    <time_frame>At baseline and at 6 ,12 and 24 months</time_frame>
    <description>Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator</measure>
    <time_frame>At baseline and at 6 ,12 and 24 months</time_frame>
    <description>Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of a triple therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator plus inhaled steroids</measure>
    <time_frame>At baseline and at 6 ,12 and 24 months</time_frame>
    <description>Use of a triple therapy of long-acting beta-adrenergic bronchodilator plus long-acting anticholinergic bronchodilator plus inhaled steroids (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids</measure>
    <time_frame>At baseline and at 6 ,12 and 24 months</time_frame>
    <description>Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Roflumilast</measure>
    <time_frame>At baseline and at 6 ,12 and 24 months</time_frame>
    <description>Use of Roflumilast (yes or no)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>COPD structured self-management plan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive usual care for COPD and in addition, a structured self-management education plan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>COPD participants receiving only usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COPD structured self-management plan.</intervention_name>
    <description>Education plan , including knowledge of the disease, healthy life habits, correct use of inhalers, skills to control symptoms and strategies to face the disease and exacerbations</description>
    <arm_group_label>COPD structured self-management plan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with at least one visit at the primary care physician during the past year&#xD;
&#xD;
          -  Patients with a diagnosis of moderate (FEV1 50% - 80%) or severe (FEV1 30% - 50%) COPD&#xD;
&#xD;
          -  Patients treated with inhaled bronchodilators and accepting to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to come to the primary care centre&#xD;
&#xD;
          -  Patients with cognitive impairment and/or a severe mental condition.&#xD;
&#xD;
          -  Patients with a diagnosis of asthma, tuberculosis or other chronic respiratory&#xD;
             disease.&#xD;
&#xD;
          -  Patients needing chronic oxygen therapy.&#xD;
&#xD;
          -  Patients with any terminal disease&#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>Maite Lopez Luque</last_name>
    <role>Principal Investigator</role>
    <affiliation>Servei Catala de la Salut</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maite Lopez Luque</last_name>
    <phone>93 326 89 01</phone>
    <email>tlopezl@gencat.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patricia Lloberes, Dr</last_name>
    <phone>+34 627906580</phone>
    <email>plloberes@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>EAP Montcada i Reixac</name>
      <address>
        <city>Barcelona</city>
        <zip>08110</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maite Lopez, Nurse</last_name>
      <phone>+24 93 3268901</phone>
      <email>tlopezl@gencat.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>self-management,</keyword>
  <keyword>structured plan</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03762330/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03762330
org study id: P17/055
nct id: NCT03762330
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of of a structured self-management intervention plan in
      patients with chronic obstructive pulmonary disease in primary care setting.Half of the
      participants will receive the self-management plan while the other half will receive usual
      care.
Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with
      an associated increased mortality and a high cost (consumption of health care resources and
      loss of health related quality of life (HRQoL)). The comprehensive approach to this complex
      disease, focusing self-care promotion, improves HRQoL and the patients" clinical status, as
      shown by several studies, although further investigation is needed to confirm these results
      in the field of Primary Care (PC) and to formulate clear recommendations on the more
      effective type of intervention.

      Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention
      plan in the setting of primary care, is more effective than usual treatment on the main
      outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital
      admissions, at 6, 12 and 24 months of follow-up.

      Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care
      and improve HRQoL in people with COPD in PC.

      Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona.

      Determinations: Specific standardized and validated questionnaires, as the St George's
      Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive
      statistics of the variables of the intervention and the control group to assess their
      homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to
      assess differences among intervention groups.

      Expected results: A significant improvement in HRQoL attributable to the intervention
      performed in patients with COPD Applicability and Relevance: To implement the intervention
      plan in clinical practice and to standardize its content.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Quality of life St. George´s Respiratory Questionnaire (SGRQ)
time frame: Change from baseline at 6 ,12 and 24 months
description: St. George´s Respiratory Questionnaire (SGRQ).Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
Number of items: 50 items Number of domains & categories : 2 parts (3 components). Part 1 : Symptoms component (frequency & severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.
Scaling of items Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale). Scores range from 0 to 100, with higher scores indicating more limitations.
measure: Intensity of symptoms related to COPD
time frame: Change from baseline at 6 ,12 and 24 months
description: COPD Assessment Test (CAT) : It consists of 8 questions with 5 possible answers valued from 0 to 5 (values close to 0: better health status)
measure: Dyspnea score severity
time frame: Change from baseline at 6 ,12 and 24 months
description: Dyspnea severity assessed by the modified scale of the Medical Research Council (mMRC). Range 0-4 (none to maximum)
measure: Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index )
time frame: Change from baseline at 6 ,12 and 24 months
description: Index including BMI (Body mass index), Obstruction, Dyspnea, Exacerbations. with possible answers from 0-3, each item. Range: 0-9. Mild: 0-2 Moderate: 3-4 Severe ≥5
measure: Number of COPD exacerbations
time frame: at 6 ,12 and 24 months from baseline
description: Number of COPD exacerbations requiring a visit to primary care physician
measure: Number of hospital admissions due to COPD exacerbation
time frame: at 6 ,12 and 24 months from baseline
description: Number of hospital admissions due to COPD exacerbation
measure: Changes in Anxiety and depression scales
time frame: Change from baseline at 6 ,12 and 24 months
description: Goldberg's anxiety-depression scale (GADS): is an 18-item self-report symptom inventory that was developed by Goldberg and colleagues from 36 items in the Psychiatric Assessment Schedule. The GADS score is based on responses of 'yes' or 'no' to nine depression and nine anxiety items, asking how respondents have been feeling in the past month. Goldberg et al. (1988) considered patients with anxiety scores of 5 or more or with depression scores of 2 or more as having a 50% chance of a clinically important disturbance
measure: Changes in forced vital capacity (FVC)
time frame: Change from baseline at 6 ,12 and 24 months
description: Value of FVC measured with forced spirometry
measure: Changes in forced expiratory volume at the first second (FEV1)
time frame: Change from baseline at 6 ,12 and 24 months
description: Value of FEV1 measured with forced spirometry
measure: Results of the Test of Adherence to Inhalers (TAI test)
time frame: Change from baseline at 6 ,12 and 24 months
description: TAI test. Includes 10 questions self-completed by patient. Range of each questions; 1worse compliance and 5 best compliance. The total score of the 10 items gives a total from 1-50.
measure: Use of long-acting beta-adrenergic bronchodilator in monotherapy
time frame: At baseline and at 6 ,12 and 24 months
description: Use of long-acting beta-adrenergic bronchodilator in monotherapy (yes or no)
measure: Use of long-acting anticholinergic bronchodilator in monotherapy
time frame: At baseline and at 6 ,12 and 24 months
description: Use of long-acting anticholinergic bronchodilator in monotherapy (yes or no)
measure: Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator
time frame: At baseline and at 6 ,12 and 24 months
description: Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator (yes or no)
measure: Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator
time frame: At baseline and at 6 ,12 and 24 months
description: Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator (yes or no)
measure: Use of a triple therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator plus inhaled steroids
time frame: At baseline and at 6 ,12 and 24 months
description: Use of a triple therapy of long-acting beta-adrenergic bronchodilator plus long-acting anticholinergic bronchodilator plus inhaled steroids (yes or no)
measure: Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids
time frame: At baseline and at 6 ,12 and 24 months
description: Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids (yes or no)
measure: Use of Roflumilast
time frame: At baseline and at 6 ,12 and 24 months
description: Use of Roflumilast (yes or no)
arm group label: COPD structured self-management plan
arm group type: Active Comparator
description: Participants will receive usual care for COPD and in addition, a structured self-management education plan.
arm group label: Usual care
arm group type: No Intervention
description: COPD participants receiving only usual care
intervention type: Behavioral
intervention name: COPD structured self-management plan.
description: Education plan , including knowledge of the disease, healthy life habits, correct use of inhalers, skills to control symptoms and strategies to face the disease and exacerbations
arm group label: COPD structured self-management plan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maite Lopez Luque
role: Principal Investigator
affiliation: Servei Catala de la Salut
last name: Maite Lopez Luque
phone: 93 326 89 01
email: tlopezl@gencat.cat
last name: Patricia Lloberes, Dr
phone: +34 627906580
email: plloberes@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
provided document: 