NCT07134855

Brief Summary

The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
473

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Jul 2028

First Submitted

Initial submission to the registry

July 30, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

July 30, 2025

Last Update Submit

August 14, 2025

Conditions

Keywords

chronic obstructive pulmonary diseaseasthmamulti-morbidity

Outcome Measures

Primary Outcomes (1)

  • Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil.

    Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil, assessed at qualitative interviews.

    A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).

Secondary Outcomes (4)

  • Spirometry

    A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).

  • Disease Control Questionnaire

    A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).

  • FeNO

    A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).

  • Disease Control Questionnaire

    A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with a non-communicable disease and found to be at high risk for, or newly diagnosed with a chronic respiratory disease

You may qualify if:

  • Participated in MARES1 and MARES2, which recruited people with non-communicable diseases attending primary healthcare services in Brazil, identified as being at high-risk for, or confirmed as having chronic respiratory diseases.

You may not qualify if:

  • No consent to take part in MARES3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Multiple primary care sites

São Carlos, São Paulo, Brazil

Location

Multiple primary care sites

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Mendes RG, Leonardi NT, Castello-Simoes V, Kawakami DMO, Souza JVR, Schafauser-Segundo NS, Simoes RP, Pinto FG, Araujo GHG, da Silva MMC, Moriguchi CS, Franco FJBZ, Pires Di Lorenzo VA, Jordan R, Martins S, Siddharthan T, Al Sharmah S, Barber J, Hurst JR. Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol. BMJ Open. 2026 Jan 16;16(1):e109950. doi: 10.1136/bmjopen-2025-109950.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • John R Hurst, PhD FRCP

    University College London Hospitals

    PRINCIPAL INVESTIGATOR
  • Renata G Mendes, DFisio

    Federal University of Sao Carlos (UFScar), Brasil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 21, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

We have no plans to share individual responses from qualitative interviews.

Locations