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AzTrials

Respiratory DiseaseNCT03230968

Use of a Respiratory Care Model in Population Older Than 15 Years in Orizaba, Veracruz Mexico

A study testing Integral Action Program for Respiration in people with Respiratory Disease, run by Instituto Nacional de Salud Publica, Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Disease
What is being tested?
Integral Action Program for Respiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
649 participants
Where
No sites listed yet
Study dates
Mar 2013to Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • People older than 15 years of age that go to one of the health clinics seeking medical attention for any cause.
  • Residency in the study site.

Who cannot join

  • None

About this study

Official title: Reduction in Morbidity, Complications and Mortality Caused by Respiratory Diseases Using a Personalized Integral Model of Care.

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.

Read the detailed description

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).

Being tested
Integral Action Program for Respiration
Keywords
Practical Approach to Lung Health, Respiratory diseases, Mexico
Medical subject headings
Respiration Disorders, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integral Action Program for RespirationBehavioural

Study groups in NCT03230968
Study groupRoleWhat they receive
Phase 1 without interventionNo interventionIn 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.
Phase 2 with interventionActive comparatorWe 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.
Receives: Behavioral: Integral Action Program for Respiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of prescribed drugs acquired in the pharmacy of the health center as stated in the questionnaire

    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)

    Measured: One month after physician consultation

  2. Accordance of prescribed treatment (based on questionnaire) with proposed guidelines

    For each respiratory disease patient we evaluated if he/she had received treatment in compliance to AIRE guidelines

    Measured: One month after physician consultation

  3. Clinical outcome of each participant based on follow up questionnaire

    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.

    Measured: One month after physician consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2017
  2. Study startMar 2013
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
649 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03230968
Sponsor's protocol ID
CI:1026
Other IDs
SALUD-2010-01-140645
Status last verified
Jul 2017
First submitted
20 Jul 2017
Last updated
28 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Integral Action Program for Respiration in people with Respiratory Disease, run by Instituto Nacional de Salud Publica, Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.

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