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.
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
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Preserved Ratio Impaired Spirometry
- How many people
- 1,000 participants
- Where
- 2 sitesBrazil
- Study dates
- Aug 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
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.
- First posted30 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Responsible party
- Sponsor
- Investigators
- John R Hurst, PhD FRCP, Principal investigator, University College London HospitalsRenata G Mendes, DFisio, Principal investigator, Federal University of Sao Carlos (UFScar), Brasil
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing the COLA-6 Case-Finding Tool to Identify Chronic Respiratory Disease in Primary Health Care in Brazil
- ClinicalTrials.gov ID
- NCT07093021
- Acronym / sponsor ID
- MARES2 / 6981600 (UCL Worktribe)
- Keywords
- case-finding, chronic obstructive pulmonary disease, asthma, multi-morbidity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- HCP: providing care to people with NCDs in PHC settings in Brazil. PATIENTS: attending for NCD care at a PHC setting in Brazil.
Key exclusion criteria (8 listed)
- HCP: not received training to deliver COLA-6.
- not provided informed consent
- clinically unstable in the past month
- current pregnancy
- active tuberculosis or being on treatment for tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Barriers and facilitators to implementing the COLA-6 case-finding tool.
Time frame: At study completion: qualitative interviews will be completed after each HCP has completed 50 uses of COLA-6.
Barriers and facilitators to implementing the COLA-6 case-finding tool, assessed at qualitative interviews.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No. We have no plans to share individual responses from qualitative interviews.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John R Hurst, PhD FRCP principal investigator
University College London Hospitals
Renata G Mendes, DFisio principal investigator
Federal University of Sao Carlos (UFScar), Brasil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by University College, London at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane Castello ((+5516) 99992 4777, vivianecastello@ufscar.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers and facilitators to implementing the COLA-6 case-finding tool. (time frame: At study completion: qualitative interviews will be completed after each HCP has completed 50 uses of COLA-6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.