Actively Recruiting

Age: 18Years +
All Genders
ID06673225

Evaluation of the Implementation of the INSPIRE Respiratory Health Program: Integration of Early Diagnosis and Emergency Response for Respiratory Diseases in Botucatu, São Paulo, Brazil

Led by UPECLIN HC FM Botucatu Unesp · Updated on 2024-11-04

2000

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

Sponsors

U

UPECLIN HC FM Botucatu Unesp

Lead Sponsor

C

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the INSPIRE Respiratory Health Program in the municipality of Botucatu, São Paulo, Brazil. This observational study aims to assess the program's implementation for early diagnosis, coordination, monitoring, and treatment of respiratory diseases. It focuses on individuals aged 18 or older with respiratory symptoms or a history of active or passive smoking. The study intends to identify vulnerable groups facing difficulties accessing respiratory care and to develop strategies for better treatment and tobacco control. Participants with respiratory symptoms, smoking history, or passive exposure will be invited for multiprofessional evaluations including pulmonary function tests, body composition analysis, muscle strength assessments, and low-dose chest CT scans for those over 40 with significant tobacco exposure. Evaluations and treatment follow-ups will occur annually, with data collected from primary to tertiary healthcare units in Botucatu. Screening includes spirometry and thoracic imaging, followed by physician assessment for specific treatments or additional exams. During the five-year longitudinal study, participants will be contacted yearly to monitor respiratory health, record disease progression, and acute exacerbations. Data on socioeconomic factors, nutrition, frailty, tobacco exposure, and mental health will be collected. Statistical analyses will compare incidence rates and clinical characteristics among groups. Data confidentiality and quality control are ensured through coded electronic databases and continuous monitoring. The primary outcome measures changes in respiratory disease incidence within one year after program implementation.

CONDITIONS

Brief Title

INSPIRE Respiratory Health Program in Botucatu, São Paulo, Brazil

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age equal to or greater than 18 years old
  • Presence of respiratory symptoms
  • History of active or passive smoking
  • Signing of informed consent form
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Initial evaluation with follow-up assessments annually for up to 5 years

Participants undergo multiprofessional evaluations including imaging, laboratory tests, spirometry, and clinical assessments to screen for respiratory diseases and determine the need for further treatment or exams.

1 initial visit and annual visits for up to 5 years

Long-term Monitoring

Duration - Up to 5 years

Participants are re-evaluated annually to record acute exacerbations, assess disease progression, and monitor respiratory health through spirometry and thoracic imaging.

Annual visits for up to 5 years

Trial Site Locations

Total: 1 location

1

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil, 18618687

Actively Recruiting

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Research Team

S

Suzana E Tanni, MD-PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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