Mitigating Chronic Respiratory Disease Through the Lens of Multi-Morbidity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorUniversity College, London
About this trial
The investigators aim to make it easier to find people with undiagnosed long-term lung health problems (such as asthma, and chronic obstructive pulmonary disease, COPD, collectively called 'Chronic Respiratory Diseases', CRDs) living in Brasil.
Because people with undiagnosed CRDs often have other medical problems too, such as heart problems, high blood pressure and diabetes (collectively called 'Long Term Conditions', LTC), the investigators will look for undiagnosed CRD in people with LTC when they are attending appointments at local health centres in the cities of Sao Carlos and Sao Paulo.
To look for undiagnosed CRDs the investigators will use two questionnaire-based methods called 'COLA' and 'SBQ'. These are quick and simple to do. All participants will also have tests of their lung function completed including spirometry and Fractional Exhaled Nitric Oxide so that the investigators can make a definite diagnosis of CRDs. When the study is complete, the investigators will examine how well the COLA and SBQ questionnaires perform in identifying people with a definite diagnosis of CRD.
In total, the investigators aim to recruit 859 people.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
People attending primary care clinics in Brasil for treatment or monitoring of an existing non-respiratory long-term condition, for example cardiovascular disease, diabetes and hypertension.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of abnormal spirometry
The investigators will report the sensitivity, specificity, positive and negative predictive value for the ability of the 'COLA' case-finding questionnaire to identify people with abnormal post-bronchodilator spirometry.
Time frame
Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of abnormal spirometry will use the COLA and spirometry data from the single visit.Secondary outcomes
1
Discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of specific patterns of abnormal spirometry
The investigators will report the sensitivity, specificity, positive and negative predictive value for the ability of the 'COLA' case-finding questionnaire to identify people with asthma, COPD and PRISm separately.
Time frame
Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of asthma, COPD and PRISm will use the COLA and spirometry data from the single visit.2
Discriminative accuracy of the 'SBQ' (symptom based questionnaire) case-finding questionnaire for diagnosis of overall, and specific patterns of abnormal spirometry
The investigators will report the sensitivity, specificity, positive and negative predictive value for the ability of the 'SBQ' (symptom based questionnaire) case-finding questionnaire to identify people with abnormal spirometry, and asthma, COPD, and PRISm separately.
Time frame
Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'SBQ' case-finding questionnaire for diagnosis of abnormal spirometry will use the SBQ and spirometry data from the single visit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
Universidade Federal de Sao Carlos
Collaborator
Source ClinicalTrials.gov