INSPIRE Respiratory Health Program in Botucatu, São Paulo, Brazil

NCT06673225 | Recruiting DMC

• 1 other identifier: Inspire2024
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Community Health Services; Respiratory Disease; Tobacco Smoking

Keywords

Primary care; Health promotion; Pulmonary function tests; Nicotine addiction; Smoking cessation

Outcome Measures

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

  One year

Secondary Outcomes (1)

• Program implementation costs

  One year

Study Arms (1)

Single group

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

Other: Analysis of results

Interventions

Analysis of results 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.

Single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, 18618687, Brazil

RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Tobacco Smoking; Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Study Officials

• Suzana E Tanni, MD-PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzana E Tanni, MD-PhD

CONTACT

+55143811-6033; suzanapneumo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: November 4, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)