Mitigating Chronic Respiratory Disease Through the Lens of Multimorbidity

NCT ID: NCT07093021

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-12-31

Brief 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.

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Asthma; Preserved Ratio Impaired Spirometry

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Multiple primary care sites

São Carlos, São Paulo, Brazil

Multiple primary care sites

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Viviane Castello

Role: CONTACT

vivianecastello@ufscar.br

(+5516) 99992 4777

Facility Contacts

Viviane Castello

Role: primary

vivianecastello@ufscar.br

(+5516) 99992 4777

Viviane Castello

Role: primary

vivianecastello@ufscar.br

(+5516) 99992 4777

Other Identifiers

NIHR 303125

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

6981600 (UCL Worktribe)

Identifier Type: -

Identifier Source: org_study_id