NCT07093021

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.

Trial Health

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Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Aug 2025

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

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Study Timeline

Key milestones and dates

Study Progress58%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

July 18, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 18, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

case-findingchronic obstructive pulmonary diseaseasthmamulti-morbidity

Outcome Measures

Primary Outcomes (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.

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

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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.

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

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 18, 2025

First Posted

July 30, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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

Locations