Mitigating Chronic Respiratory Disease Through the Lens of Multimorbidity (MARES3)
NCT ID: NCT07134855
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
473 participants
OBSERVATIONAL
2025-09-01
2028-07-31
Brief Summary
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The investigators will re-assess people diagnosed with abnormal spirometry in the MARES1 study (NCT07050823) or identified as being at high-risk for CRDs in the MARES2 study (NCT07093021). The estimated sample size is 309 from MARES1 and 164 from MARES2 for a total sample size of 473.
Qualitative interviews will be conducted with a diverse subsample of 30 participants to explore their experience accessing CRD diagnosis and treatment, including barriers and facilitators, while all participants will undergo basic data collection and spirometry.
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Detailed Description
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The study will be carried out in PHC services, including Basic Health Units (BHUs) and Family Health Units (FHUs), located in the municipalities of São Carlos and São Paulo, both in the state of São Paulo, Brazil.
Individuals are being followed up after participation in MARES1 study (NCT07050823) and MARES2 study (NCT07093021), and had been originally recruited from PHC services, including BHUs and FHUs, located in the municipalities of São Carlos and São Paulo, Brazil. People were recruited if they were attending a PHC service for care of a NCD.
At the research visit, all participants will be asked about access to care. In addition, all participants will have application of the CAAT questionnaire, and the ACQ-7 questionnaire for those with asthma, and all participants will have measurement of pre- and post-bronchodilator spirometry and Fraction of Exhaled Nitric Oxide (FeNO).
A semi-structured interviews will be conducted with a sample of 30 patients diagnosed with abnormal spirometry results: 10 with COPD, 10 with asthma, and 10 with PRISm or restriction. These face-to-face interviews will use open-ended questions, be audio-recorded, transcribed, and anonymized before analysis. Participants will be randomly selected to ensure diversity in gender, age, socioeconomic status, and employment background. The interview will explore how participants accessed healthcare services for diagnostic confirmation and treatment, and how this process affected their health status. Topics will include barriers and facilitators, how doubts were clarified, the type of education they received regarding the disease, diagnosis, and treatment, and whether any changes occurred in their lifestyle or routine following diagnosis or treatment.
The qualitative analysis of the interviews will follow Braun and Clarke, which consists of six phases: 1) Familiarization with the data set; 2) Coding; 3) Generation of initial themes; 4) Development and review of themes; 5) Refinement, definition and naming of themes; and 6) Writing. Descriptive statistics will be used to describe responses to questionnaires and lung function testing, including changes from the values recorded at recruitment to MARES1 and MARES2.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
ALL
No
Sponsors
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Universidade Federal de Sao Carlos
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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John R Hurst, PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Renata G Mendes, DFisio
Role: PRINCIPAL_INVESTIGATOR
Federal University of Sao Carlos (UFScar), Brasil
Locations
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Multiple primary care sites
São Carlos, São Paulo, Brazil
Multiple primary care sites
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NIHR 303125
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UCL Worktribe 6981600
Identifier Type: -
Identifier Source: org_study_id
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