<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/NCT03230968</url>
  </required_header>
  <id_info>
    <org_study_id>CI:1026</org_study_id>
    <secondary_id>SALUD-2010-01-140645</secondary_id>
    <nct_id>NCT03230968</nct_id>
  </id_info>
  <brief_title>Use of a Respiratory Care Model in Population Older Than 15 Years in Orizaba, Veracruz Mexico</brief_title>
  <official_title>Reduction in Morbidity, Complications and Mortality Caused by Respiratory Diseases Using a Personalized Integral Model of Care.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Salud Publica, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Nacional de Enfermedades Respiratorias</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Salud Publica, Mexico</source>
  <oversight_info>
    <has_dmc>No</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>
      Background. Mexico is lacking guidelines that provide an integral approach for the prevention&#xD;
      and control of respiratory diseases in adults. The World Health Organization (WHO) proposed a&#xD;
      &quot;Practical Approach to Lung Health&quot; (PAL) using generic guidelines to be used in primary&#xD;
      health care settings for diagnosis and treatment of respiratory diseases. These guidelines&#xD;
      were adapted to the Mexican context as AIRE campaign by the Instituto Nacional de&#xD;
      Enfermedades Respiratorias, Mexico. Objective. To evaluate the feasibility and effectiveness&#xD;
      of implementing a model of care for respiratory diseases in adults based on AIRE guidelines,.&#xD;
      Materials and methods. Prospective quasi-experimental pre-post study. During 03-08/2013&#xD;
      (phase 1), investigators recruited consenting subjects older than 15 years of age seeking&#xD;
      medical care in primary care centers in Orizaba, Veracruz. Researchers investigated&#xD;
      sociodemographic, epidemiological and clinical information before consultation. On patients&#xD;
      who had been diagnosed with respiratory disease by a physician, researchers investigated&#xD;
      prescribed treatment on leaving the physician´s office. A month later conducted a home visit&#xD;
      to investigate clinical outcome. During 09/2014 we trained doctors from the participating&#xD;
      health centers in &quot;AIRE&quot; guidelines. From 10/2014 to 03/2015 (phase 2) researchers again&#xD;
      surveyed all consenting subjects older than 15 years of age who received health services in&#xD;
      the same health centers following the same procedures as in phase 1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design was that of a prospective quasi-experimental pre-post study. A pre-survey and a&#xD;
      follow-up survey were used.Investigators selected 4 health centers in the Sanitary&#xD;
      Jurisdiction in Orizaba, Veracruz, two located in rural areas (Potrerillo and Tlilapan) and&#xD;
      two located in urban areas (Río Blanco and Orizaba). The pre-survey (phase1) was conducted on&#xD;
      all consenting individuals older than 15 years seeking health services in selected health&#xD;
      centers. Before the physician consultation, researchers investigated sociodemographic,&#xD;
      epidemiologic, clinical characteristics and reason for seeking health services. Immediately&#xD;
      after consultation, researchers asked the patient his/her diagnoses. Investigators confirmed&#xD;
      all diagnoses with treating physicians. If the patient had been diagnosed with respiratory&#xD;
      disease, researchers collected information on prescribed treatment, and classified the type&#xD;
      of respiratory disease and comorbidities based on the 10th International Classification of&#xD;
      Diseases (ICD-10). Researchers conducted a home visit one month after the consultation to&#xD;
      determine clinical evolution, occurrence of referral to a specialist, if the patient had&#xD;
      obtained prescribed drugs at the health center or at a private drugstore and if the patients&#xD;
      had been hospitalized.&#xD;
&#xD;
      During September 2014 researchers trained health personnel from the participating health&#xD;
      centers on implementation of the proposed model based on the AIRE guidelines previously&#xD;
      approved by the AIRE committee of the INER. The AIRE guidelines have been adapted from WHO&#xD;
      &quot;Practical Approach to Lung Health&quot; and include management of asthma, acute respiratory&#xD;
      infections (ARI, that comprises acute bronchitis and pneumonia), chronic obstructive&#xD;
      pulmonary disease (COPD), infections of the upper respiratory airways, and preventive&#xD;
      measures for smoking, tuberculosis and breathing disorders during sleep.&#xD;
&#xD;
      The model was presented to the authorities of the participating health services and of the&#xD;
      local hospital (Regional Hospital in Río Blanco (HRRB, its acronym in Spanish) as well as to&#xD;
      health personnel involved in treatment of respiratory diseases, to promote their&#xD;
      participation, counseling and support for the referral and counter-referral of patients.&#xD;
&#xD;
      The implementation of the guidelines included: 1) availability of the guidelines for the&#xD;
      management of respiratory diseases in primary care &quot;AIRE&quot;, that were revised and modified&#xD;
      based on the analysis of the first phase of the study. Physicians providing primary care in&#xD;
      the health centers and at the local hospital revised the guidelines to ensure that language&#xD;
      was understandable. 2) Distribution of educational materials to health personnel including&#xD;
      printed and electronic versions of AIRE guidelines, algorithm for management of acute and&#xD;
      severe respiratory disease, and operational and good clinical practices manuals; 3) Training&#xD;
      at the INER of the pulmonologist of the local hospital on AIRE guidelines and certification&#xD;
      in spirometry. 4) Development of two workshops for 97 physicians and nurses of the&#xD;
      participating health centers on AIRE Guidelines, oximetry tests, spirometry, referral and&#xD;
      counter-referral of patients and clinical cases with the participation of specialized&#xD;
      physicians from the INER, HRRB and the Instituto Nacional de Salud Pública (INSP); 5)&#xD;
      Creation of a respiratory health network between primary care facilities, hospital and public&#xD;
      health offices.&#xD;
&#xD;
      Researchers considered that patients participated in one of the two phases according to the&#xD;
      period in which they sought health services.&#xD;
&#xD;
      Researchers defined a patient with a respiratory disease as any patient who after&#xD;
      consultation with a physician was diagnosed with a respiratory disease according to the&#xD;
      ICD-10. The medical diagnosis was obtained from the patient and confirmed with the treating&#xD;
      physician and classified according to ICD-10. Respiratory diseases were classified in the&#xD;
      following categories: emphysema, asthma and bronchitis, allergic rhinitis, lung cancer,&#xD;
      chronic bronchitis, COPD and TB. Researchers also used a second categorization as follows:&#xD;
      viral infections, bacterial infections and chronic diseases following the national clinical&#xD;
      practice guidelines . Comorbidities were classified in the following categories: diabetes,&#xD;
      hypertension, HIV and heart disease. The reason for seeking medical attention was classified&#xD;
      into 20 categories. Researchers defined timeliness in requesting of health services measuring&#xD;
      the interval from the onset of symptoms to request of physician consultation both as a&#xD;
      continuous variable and as a dichotomic variable using as cut off &gt;3 days. Researchers&#xD;
      obtained the physician prescription and classified prescribed drugs as antibiotics,&#xD;
      corticosteroids, cough suppressants, expectorants, bronchodilators, analgesics and&#xD;
      antihistamines. Researchers also grouped cough suppressants, expectorants, analgesics and&#xD;
      antihistamines in one category.&#xD;
&#xD;
      Researchers categorized age in 3 groups: 15 to 44 years, 45 to 59 years and &gt;60 years. The&#xD;
      variable &quot;type of floor&quot; was classified in two categories (hard floor/earth floor) according&#xD;
      to the material of the floor.&#xD;
&#xD;
      Smoking was categorized as whether the patient was a current smoker or not. Alcohol&#xD;
      consumption was dichotomized in more or equal or less than 14 alcoholic drinks per week. Use&#xD;
      of drugs was categorized as to whether the patient reported using drugs during the study&#xD;
      period. Researchers considered a patient was exposed to dust or smoke if he/she had worked&#xD;
      for more than a year in a place with dust, smoke or vapors. Researchers considered&#xD;
      occupational exposure to asbestos if the patient had worked for more than a year in a place&#xD;
      with asbestos. Biomass exposure was categorized as whether the patient was currently exposed&#xD;
      or not.&#xD;
&#xD;
      Researchers compared sociodemographic, epidemiologic and clinical characteristics of patients&#xD;
      demanding physician consultation and of patients who were diagnosed with respiratory disease&#xD;
      according to study period. In the bivariate analysis researchers used U of Mann Whitney test&#xD;
      for continuous variables that didn't follow a normal distribution, chi-squared of Pearson&#xD;
      test for dichotomous variables and binomial test for categorical variables.&#xD;
&#xD;
      Researchers compared by bivariate analyses the following outcomes according to study phase:&#xD;
      1) Acquisition of prescribed drugs in the pharmacy of the health center; 2) Treatment based&#xD;
      on guidelines; 3) Clinical outcome; 4) Referral to a specialist. Using multivariate&#xD;
      unconditional logistic regression, we built three models to investigate the association&#xD;
      between phase of the study and 1) Acquisition of prescribed drugs in the pharmacy of the&#xD;
      health center; 2) Treatment based on guidelines; 3) Clinical outcome. Variables with p &lt; 0.20&#xD;
      in the bivariate analysis and biological plausibility were included in multivariate models.&#xD;
      Multivariate models were built considering patients as clusters given that each patient could&#xD;
      have had more than one drug prescription. Researchers estimated the odds ratio (OR) and 95&#xD;
      per cent confidence intervals (95% CI), and identified the covariates that were independently&#xD;
      associated with each outcome.&#xD;
&#xD;
      All statistical analyses were performed using the statistical package STATA V13.3 (StataCorp&#xD;
      LP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of prescribed drugs acquired in the pharmacy of the health center as stated in the questionnaire</measure>
    <time_frame>One month after physician consultation</time_frame>
    <description>The variable was categorized in: health center (all the prescribed medication was obtained from the pharmacy in the health center), and other pharmacy and/or health center (all or a part of prescribed medication was obtained in private establishments)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accordance of prescribed treatment (based on questionnaire) with proposed guidelines</measure>
    <time_frame>One month after physician consultation</time_frame>
    <description>For each respiratory disease patient we evaluated if he/she had received treatment in compliance to AIRE guidelines</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical outcome of each participant based on follow up questionnaire</measure>
    <time_frame>One month after physician consultation</time_frame>
    <description>Clinical outcome was classified as follows: cure (disappearance of signs and symptoms and patient described as &quot;healthy&quot;), improvement (improvement of signs and symptoms), drop out (the patient stopped taking prescribed medications despite continuing signs and symptoms), still on treatment or death.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">649</enrollment>
  <condition>Respiratory Disease</condition>
  <arm_group>
    <arm_group_label>Phase 1 without intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In selected heath centers we interviewed all consenting patients older than 15 years. Before the physician consultation, we investigated sociodemographic, epidemiologic, clinical characteristics and reason for seeking health services. Immediately after consultation, we asked the patient his/her diagnoses. We confirmed all diagnoses with treating physicians. If the patient had been diagnosed with respiratory disease, we collected information on prescribed treatment, and classified the type of respiratory disease and comorbidities based on the 10th International Classification of Diseases (ICD-10). Patients were given follow up one month later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 with intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We trained health personnel from the participating health centers on implementation of the proposed model based on the AIRE guidelines previously approved by the AIRE committee of the National Institute for Respiratory Diseases. The AIRE guidelines have been adapted from WHO &quot;Practical Approach to Lung Health&quot;. Once the model was in action we interviewed all consenting patients older than 15 years as in phase 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integral Action Program for Respiration</intervention_name>
    <arm_group_label>Phase 2 with intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People older than 15 years of age that go to one of the health clinics seeking medical&#xD;
             attention for any cause.&#xD;
&#xD;
        Residency in the study site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Ferreira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Salud Pública</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Salud Publica, Mexico</investigator_affiliation>
    <investigator_full_name>Edith Elizabeth Ferreira Guerrero</investigator_full_name>
    <investigator_title>Epidemiologist</investigator_title>
  </responsible_party>
  <keyword>Practical Approach to Lung Health</keyword>
  <keyword>Respiratory diseases</keyword>
  <keyword>Mexico</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</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/NCT03230968
org study id: CI:1026
secondary id: SALUD-2010-01-140645
nct id: NCT03230968
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background. Mexico is lacking guidelines that provide an integral approach for the prevention
      and control of respiratory diseases in adults. The World Health Organization (WHO) proposed a
      "Practical Approach to Lung Health" (PAL) using generic guidelines to be used in primary
      health care settings for diagnosis and treatment of respiratory diseases. These guidelines
      were adapted to the Mexican context as AIRE campaign by the Instituto Nacional de
      Enfermedades Respiratorias, Mexico. Objective. To evaluate the feasibility and effectiveness
      of implementing a model of care for respiratory diseases in adults based on AIRE guidelines,.
      Materials and methods. Prospective quasi-experimental pre-post study. During 03-08/2013
      (phase 1), investigators recruited consenting subjects older than 15 years of age seeking
      medical care in primary care centers in Orizaba, Veracruz. Researchers investigated
      sociodemographic, epidemiological and clinical information before consultation. On patients
      who had been diagnosed with respiratory disease by a physician, researchers investigated
      prescribed treatment on leaving the physician´s office. A month later conducted a home visit
      to investigate clinical outcome. During 09/2014 we trained doctors from the participating
      health centers in "AIRE" guidelines. From 10/2014 to 03/2015 (phase 2) researchers again
      surveyed all consenting subjects older than 15 years of age who received health services in
      the same health centers following the same procedures as in phase 1.
The design was that of a prospective quasi-experimental pre-post study. A pre-survey and a
      follow-up survey were used.Investigators selected 4 health centers in the Sanitary
      Jurisdiction in Orizaba, Veracruz, two located in rural areas (Potrerillo and Tlilapan) and
      two located in urban areas (Río Blanco and Orizaba). The pre-survey (phase1) was conducted on
      all consenting individuals older than 15 years seeking health services in selected health
      centers. Before the physician consultation, researchers investigated sociodemographic,
      epidemiologic, clinical characteristics and reason for seeking health services. Immediately
      after consultation, researchers asked the patient his/her diagnoses. Investigators confirmed
      all diagnoses with treating physicians. If the patient had been diagnosed with respiratory
      disease, researchers collected information on prescribed treatment, and classified the type
      of respiratory disease and comorbidities based on the 10th International Classification of
      Diseases (ICD-10). Researchers conducted a home visit one month after the consultation to
      determine clinical evolution, occurrence of referral to a specialist, if the patient had
      obtained prescribed drugs at the health center or at a private drugstore and if the patients
      had been hospitalized.

      During September 2014 researchers trained health personnel from the participating health
      centers on implementation of the proposed model based on the AIRE guidelines previously
      approved by the AIRE committee of the INER. The AIRE guidelines have been adapted from WHO
      "Practical Approach to Lung Health" and include management of asthma, acute respiratory
      infections (ARI, that comprises acute bronchitis and pneumonia), chronic obstructive
      pulmonary disease (COPD), infections of the upper respiratory airways, and preventive
      measures for smoking, tuberculosis and breathing disorders during sleep.

      The model was presented to the authorities of the participating health services and of the
      local hospital (Regional Hospital in Río Blanco (HRRB, its acronym in Spanish) as well as to
      health personnel involved in treatment of respiratory diseases, to promote their
      participation, counseling and support for the referral and counter-referral of patients.

      The implementation of the guidelines included: 1) availability of the guidelines for the
      management of respiratory diseases in primary care "AIRE", that were revised and modified
      based on the analysis of the first phase of the study. Physicians providing primary care in
      the health centers and at the local hospital revised the guidelines to ensure that language
      was understandable. 2) Distribution of educational materials to health personnel including
      printed and electronic versions of AIRE guidelines, algorithm for management of acute and
      severe respiratory disease, and operational and good clinical practices manuals; 3) Training
      at the INER of the pulmonologist of the local hospital on AIRE guidelines and certification
      in spirometry. 4) Development of two workshops for 97 physicians and nurses of the
      participating health centers on AIRE Guidelines, oximetry tests, spirometry, referral and
      counter-referral of patients and clinical cases with the participation of specialized
      physicians from the INER, HRRB and the Instituto Nacional de Salud Pública (INSP); 5)
      Creation of a respiratory health network between primary care facilities, hospital and public
      health offices.

      Researchers considered that patients participated in one of the two phases according to the
      period in which they sought health services.

      Researchers defined a patient with a respiratory disease as any patient who after
      consultation with a physician was diagnosed with a respiratory disease according to the
      ICD-10. The medical diagnosis was obtained from the patient and confirmed with the treating
      physician and classified according to ICD-10. Respiratory diseases were classified in the
      following categories: emphysema, asthma and bronchitis, allergic rhinitis, lung cancer,
      chronic bronchitis, COPD and TB. Researchers also used a second categorization as follows:
      viral infections, bacterial infections and chronic diseases following the national clinical
      practice guidelines . Comorbidities were classified in the following categories: diabetes,
      hypertension, HIV and heart disease. The reason for seeking medical attention was classified
      into 20 categories. Researchers defined timeliness in requesting of health services measuring
      the interval from the onset of symptoms to request of physician consultation both as a
      continuous variable and as a dichotomic variable using as cut off >3 days. Researchers
      obtained the physician prescription and classified prescribed drugs as antibiotics,
      corticosteroids, cough suppressants, expectorants, bronchodilators, analgesics and
      antihistamines. Researchers also grouped cough suppressants, expectorants, analgesics and
      antihistamines in one category.

      Researchers categorized age in 3 groups: 15 to 44 years, 45 to 59 years and >60 years. The
      variable "type of floor" was classified in two categories (hard floor/earth floor) according
      to the material of the floor.

      Smoking was categorized as whether the patient was a current smoker or not. Alcohol
      consumption was dichotomized in more or equal or less than 14 alcoholic drinks per week. Use
      of drugs was categorized as to whether the patient reported using drugs during the study
      period. Researchers considered a patient was exposed to dust or smoke if he/she had worked
      for more than a year in a place with dust, smoke or vapors. Researchers considered
      occupational exposure to asbestos if the patient had worked for more than a year in a place
      with asbestos. Biomass exposure was categorized as whether the patient was currently exposed
      or not.

      Researchers compared sociodemographic, epidemiologic and clinical characteristics of patients
      demanding physician consultation and of patients who were diagnosed with respiratory disease
      according to study period. In the bivariate analysis researchers used U of Mann Whitney test
      for continuous variables that didn't follow a normal distribution, chi-squared of Pearson
      test for dichotomous variables and binomial test for categorical variables.

      Researchers compared by bivariate analyses the following outcomes according to study phase:
      1) Acquisition of prescribed drugs in the pharmacy of the health center; 2) Treatment based
      on guidelines; 3) Clinical outcome; 4) Referral to a specialist. Using multivariate
      unconditional logistic regression, we built three models to investigate the association
      between phase of the study and 1) Acquisition of prescribed drugs in the pharmacy of the
      health center; 2) Treatment based on guidelines; 3) Clinical outcome. Variables with p < 0.20
      in the bivariate analysis and biological plausibility were included in multivariate models.
      Multivariate models were built considering patients as clusters given that each patient could
      have had more than one drug prescription. Researchers estimated the odds ratio (OR) and 95
      per cent confidence intervals (95% CI), and identified the covariates that were independently
      associated with each outcome.

      All statistical analyses were performed using the statistical package STATA V13.3 (StataCorp
      LP).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Number of prescribed drugs acquired in the pharmacy of the health center as stated in the questionnaire
time frame: One month after physician consultation
description: The variable was categorized in: health center (all the prescribed medication was obtained from the pharmacy in the health center), and other pharmacy and/or health center (all or a part of prescribed medication was obtained in private establishments)
measure: Accordance of prescribed treatment (based on questionnaire) with proposed guidelines
time frame: One month after physician consultation
description: For each respiratory disease patient we evaluated if he/she had received treatment in compliance to AIRE guidelines
measure: Clinical outcome of each participant based on follow up questionnaire
time frame: One month after physician consultation
description: Clinical outcome was classified as follows: cure (disappearance of signs and symptoms and patient described as "healthy"), improvement (improvement of signs and symptoms), drop out (the patient stopped taking prescribed medications despite continuing signs and symptoms), still on treatment or death.
arm group label: Phase 1 without intervention
arm group type: No Intervention
description: In selected heath centers we interviewed all consenting patients older than 15 years. Before the physician consultation, we investigated sociodemographic, epidemiologic, clinical characteristics and reason for seeking health services. Immediately after consultation, we asked the patient his/her diagnoses. We confirmed all diagnoses with treating physicians. If the patient had been diagnosed with respiratory disease, we collected information on prescribed treatment, and classified the type of respiratory disease and comorbidities based on the 10th International Classification of Diseases (ICD-10). Patients were given follow up one month later.
arm group label: Phase 2 with intervention
arm group type: Active Comparator
description: We trained health personnel from the participating health centers on implementation of the proposed model based on the AIRE guidelines previously approved by the AIRE committee of the National Institute for Respiratory Diseases. The AIRE guidelines have been adapted from WHO "Practical Approach to Lung Health". Once the model was in action we interviewed all consenting patients older than 15 years as in phase 1.
intervention type: Behavioral
intervention name: Integral Action Program for Respiration
arm group label: Phase 2 with intervention
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth Ferreira, MD
role: Principal Investigator
affiliation: Instituto Nacional de Salud Pública
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Salud Publica, Mexico
investigator full name: Edith Elizabeth Ferreira Guerrero
investigator title: Epidemiologist
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: No