INSPIRE Respiratory Health Program in Botucatu, São Paulo, Brazil

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUPECLIN HC FM Botucatu Unesp

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age equal to or greater than 18 years old;

Respiratory symptoms

History of active or passive smoking

Signing of informed consent form

Disqualifiers

Difficulty understanding the issues addressed

Inability to contact by phone

Non-signing or withdrawal of informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Analysis of results

    Other intervention

    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.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Single group1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of changes in respiratory disease incidence following the implementation of the INSPIRE Program in Botucatu

This primary outcome assesses the program's effectiveness in public health by directly measuring changes in the incidence of respiratory diseases within the target population

Time frame
One year

Secondary outcomes

1

Program implementation costs

This measure estimates the total costs associated with implementing the program. It includes all expenditures related to program activities and administration.

Time frame
One year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UPECLIN HC FM Botucatu Unesp

Lead sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborator