INSPIRE Respiratory Health Program in Botucatu, São Paulo, Brazil

NCT ID: NCT06673225

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2029-12-01

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.

Conditions

Community Health Services; Respiratory Disease; Tobacco Smoking

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single group

History of smoking and/or passive exposure and/or respiratory symptoms.

Analysis of results

Intervention Type: OTHER

Analysis of previous imaging and/or laboratory tests, vital signs, body composition, pulmonary function, peripheral muscle strength, calf circumference, nutritional risk, quality of life, frailty level, and anxiety and depression. Screening for respiratory diseases, including chronic obstructive pulmonary disease (COPD), lung cancer, tuberculosis, and other lung lesions, is based on spirometry and thoracic radiological images after the health professional's examination. After the multiprofessional procedures, patients will be evaluated by a physician to start specific treatment and/or perform complementary exams if necessary. Every year, they will be re-evaluated to record acute exacerbations of chronic respiratory diseases and assess disease progression through spirometry and thoracic radiological images.

Interventions

Analysis of results

Analysis of previous imaging and/or laboratory tests, vital signs, body composition, pulmonary function, peripheral muscle strength, calf circumference, nutritional risk, quality of life, frailty level, and anxiety and depression. Screening for respiratory diseases, including chronic obstructive pulmonary disease (COPD), lung cancer, tuberculosis, and other lung lesions, is based on spirometry and thoracic radiological images after the health professional's examination. After the multiprofessional procedures, patients will be evaluated by a physician to start specific treatment and/or perform complementary exams if necessary. Every year, they will be re-evaluated to record acute exacerbations of chronic respiratory diseases and assess disease progression through spirometry and thoracic radiological images.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzana E Tanni, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

São Paulo State University (UNESP), Medical School, Botucatu

Locations

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Suzana E Tanni, MD-PhD

Role: CONTACT

suzanapneumo@gmail.com

+55143811-6033

Facility Contacts

Suzana E Tanni, MD-PhD

Role: primary

Other Identifiers

Inspire2024

Identifier Type: -

Identifier Source: org_study_id