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Chronic Obstructive Pulmonary Disease (COPD)MARES2NCT07093021

Mitigating Chronic Respiratory Disease Through the Lens of Multimorbidity

An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by University College, London at 2 sites in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

The investigators aim to evaluate whether it is feasible for healthcare professionals to implement a case-finding tool to identify individuals at high risk for chronic respiratory diseases (CRDs) during routine care for non-communicable diseases (NCDs) in primary healthcare services in Brazil. Read more about this study

Who is it for?
Ages 30 years and older
How many people
1,000 participants
Where
2 sitesBrazil
Study dates
Aug 2025to Dec 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 1. HCPs providing NCD care in PHC services in Brazil. 2. Patients attending for NCD care in PHC services in Brazil.

Who may be able to join

  • HCP: providing care to people with NCDs in PHC settings in Brazil. PATIENTS: attending for NCD care at a PHC setting in Brazil.

Who cannot join

  • HCP: not received training to deliver COLA-6.
  • PATIENTS:
  • not provided informed consent
  • clinically unstable in the past month
  • current pregnancy
  • active tuberculosis or being on treatment for tuberculosis
  • cognitive impairment that would prevent understanding of the case-finding tool
  • contra-indications to lung function testing.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil2 sites
  • Multiple primary care sites

    São Carlos, São Paulo

    Viviane Castello, (+5516) 99992 4777, vivianecastello@ufscar.br

  • Multiple primary care sites

    São Paulo, São Paulo

    Viviane Castello, (+5516) 99992 4777, vivianecastello@ufscar.br

Other trials in Brazil

About this study

Official title: Feasibility of Implementing the COLA-6 Case-Finding Tool to Identify Chronic Respiratory Disease in Primary Health Care in Brazil

The investigators aim to evaluate whether it is feasible for healthcare professionals to implement a case-finding tool to identify individuals at high risk for chronic respiratory diseases (CRDs) during routine care for non-communicable diseases (NCDs) in primary healthcare services in Brazil.

The investigators will complete a cross-sectional observational study involving 20 healthcare professionals (physicians, physiotherapists, community health agents, and nurses) from five primary healthcare services who will apply the COLA-6 tool during routine NCD care. A total sample of 1,000 patients is expected. Qualitative interviews will be conducted with healthcare professionals to explore barriers and facilitators to implementing COLA-6 in clinical practice.

Read the detailed description

The investigators will assess the feasibility of healthcare professionals implementing the COLA-6 case-finding tool to identify individuals at high-risk of chronic respiratory diseases (CRDs) in primary health care (PHC) settings for non-communicable disease (NCD) care in Brazil. CRDs include asthma and chronic obstructive pulmonary disease (COPD). The COLA-6 ("COPD in Low- and Middle-Income Countries Assessment") is a validated and simple case-finding strategy designed to identify individuals at risk for CRDs in low- and middle-income country (LMIC) settings.

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.

The study will include two main participant groups:

(1) individuals with one or more NCDs who receive care from PHC services, and (2) healthcare professionals (HCPs) working in these settings.

HCPs will be recruited from BHUs and FHUs in São Carlos and São Paulo.

Eligible patients with NCDs will be identified by HCPs during routine appointments for NCDs (e.g., hypertension, diabetes, etc.). All participants will provide written informed consent.

The study comprises two phases:

Phase 1 - Implementation of COLA-6:

Application of the COLA-6 tool: After receiving prior training from the research team, HCPs at the BHUs and FHUs will identify potentially eligible individuals with NCDs who attend PHC services and will administer the COLA-6 tool as part of their routine care. Participants identified as being at high risk for CRDs based on the COLA-6 results will receive a leaflet with basic guidance on accessing diagnostic and treatment services for respiratory conditions.

Fidelity Monitoring: Selected administration of the COLA-6 tool by each HCP will be observed by the research team to ensure adherence to protocol.

Phase 2 - Evaluation of Implementation:

Upon completion of the 50 COLA-6 applications, HCPs will participate in qualitative interviews conducted by the research team to explore the barriers and facilitators to implementation in routine PHC settings.

Interviews will be audio-recorded, transcribed verbatim, and anonymized prior to analysis. The questions will address feasibility aspects such as the time required to complete the questionnaire, difficulties encountered, clarity of the questions, uncertainties during integration of the tool into the work routine, and patient receptiveness.

The research team will work in five BHU/FHUs, with five HCPs at each unit, each administering COLA-6 to fifty patients.

Patients identified as being at high risk for CRDs will be asked if they can be contacted for future research.

Descriptive statistics will be used to characterize patient and professional samples. Quantitative analysis of fidelity data will report categorical variables as frequencies (percentages). 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.

Keywords
case-finding, chronic obstructive pulmonary disease, asthma, multi-morbidity
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Barriers and facilitators to implementing the COLA-6 case-finding tool.

    Barriers and facilitators to implementing the COLA-6 case-finding tool, assessed at qualitative interviews.

    Measured: At study completion: qualitative interviews will be completed after each HCP has completed 50 uses of COLA-6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07093021
Sponsor's protocol ID
6981600 (UCL Worktribe)
Other IDs
NIHR 303125
Acronym
MARES2
Status last verified
Jul 2025
First submitted
18 Jul 2025
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We have no plans to share individual responses from qualitative interviews.

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