Clinical trial NCT06673225: INSPIRE Respiratory Health Program in Botucatu, São Paulo, Brazil
Official title: Evaluation of the Implementation of the INSPIRE Respiratory Health Program: Integration of Early Diagnosis and Emergency Response for Respiratory Diseases in the City of Botucatu, São Paulo, Brazil
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Community Health Services
Respiratory Disease
Tobacco Smoking
Keywords: Primary care
Health promotion
Pulmonary function tests
Nicotine addiction
Smoking cessation
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2024-11-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a history of smoking and/or passive exposure and/or respiratory symptoms residing in the city of Botucatu, state of São Paulo, Brazil.

Brief summary: The goal of this observational study is to evaluate the implementation of the INSPIRE program and to plan actions for the preparation, coordination, monitoring, diagnosis, and treatment of respiratory diseases in the municipality of Botucatu. Methods: Individuals with respiratory symptoms from the municipality of Botucatu, aged 18 or older, will be invited to participate in the study, and socioeconomic data, as well as information on sex, gender, race, nutritional risk, frailty, tobacco exposure, and its derivatives, will be collected. For those with exposure, screening and treatment for respiratory diseases will be offered through assessment of pulmonary function, body composition, respiratory and peripheral muscle strength. Additionally, individuals over 40 years old with tobacco exposure equal to or greater than 30 pack-years will be offered low-dose chest CT screening for lung cancer. Expected results: To identify and assess vulnerable groups that face difficulties in accessing respiratory healthcare, as well as implement specific strategies for the treatment of respiratory diseases and tobacco control for these groups. To ensure equitable access to respiratory health for the entire population at risk due to smoking. Moreover, through proactive and reactive risk reduction actions implemented by the program, to intervene in distinct groups and other regions.

Detailed description: The project focuses on evaluating the management in the implementation of the INSPIRE respiratory health program, being applied in the health network of the municipality of Botucatu with the active co-participation of municipal managers and the local population, aiming to achieve all the proposed results. This thorough evaluation will be conducted through a longitudinal cohort study, with patient follow-up over five years. All evaluated subjects will be contacted annually to contribute to effective management and positive outcomes in respiratory health. The primary care networks (basic health and family health networks), secondary care, including urgent care and emergency units, and tertiary health care in Botucatu (tertiary hospital in the municipality of Botucatu) will participate.

The local media and primary health care unit will be informed of the monthly dates on which individuals with a history of smoking and/or passive exposure and/or respiratory symptoms can be referred for a multiprofessional evaluation. This referral can be made during a consultation or by spontaneous demand at the primary health care unit, which in turn will refer for specialized evaluation.

Statistical analyses will be divided into three main packages: disease incidence, clinical evaluation, and AI algorithms. Positive cases occurring during the evaluation period will be considered for disease incidence. For incidence calculation, the time to diagnosis for each participant will be considered in a measure expressed in person-years. Poisson regression models will be applied to estimate the relative risk for incidence among all possible groups to compare sociodemographic and other characteristics. Adjustments for possible confounding factors may be necessary and will be decided later. The second package includes the comparison between clinical characteristics and body composition. Positively and negatively screened individuals will be compared using appropriate statistical tests. Continuous variables will be tested for symmetry, and appropriate tests will be conducted (t-test or Wilcoxon; ANOVA or Mann-Whitney; parametric or non-parametric regression models). Fisher's exact tests and Chi-square (heterogeneity or trends) will be used for categorical variables.

Each participant will have their coding, preventing the identification of patients. Medical data will be kept confidential and securely stored. To ensure data quality, all researchers will be trained before the start of the study, contact with the coordinator will be allowed to clarify study protocol-related doubts, coded electronic databases will be used, which will be monitored by an external team to the study and will draw patient codes that will be monitored and their data certified. Discrepant data will automatically question the veracity of the data to reduce data inconsistency. Data will be continuously monitored to identify and correct inconsistencies. The data capture program will be REDCap, in which the developer will be solely responsible for database modifications after approval by the scientific committee.

Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 18 years old;
* Respiratory symptoms
* History of active or passive smoking
* Signing of informed consent form

Exclusion Criteria:

* Difficulty understanding the issues addressed
* Inability to contact by phone
* Non-signing or withdrawal of informed consent

Primary outcomes:
measure: Evaluation of changes in respiratory disease incidence following the implementation of the INSPIRE Program in Botucatu
timeFrame: One year
Secondary outcomes:
measure: Program implementation costs
timeFrame: One year
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu
state: São Paulo
Study officials:
affiliation: São Paulo State University (UNESP), Medical School, Botucatu
name: Suzana E Tanni, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: