Chronic Obstructive Pulmonary Disease (COPD), TB - Tuberculosis
Conditions
Keywords
COPD, TB, active case-finding strategy
Brief summary
The goal of this trial is to evaluate the effectiveness of an active case-finding (ACF) strategy for detecting pulmonary tuberculosis (PTB) among patients with chronic obstructive pulmonary disease (COPD) in primary care settings in Henan Province, China. It will also assess the epidemiological status of COPD-PTB comorbidity in this population and evaluate the feasibility of the ACF strategy in real-world primary care settings. This is a stepped-wedge cluster randomized controlled trial. Specifically, the intervention group will receive the ACF strategy in Year 1, Year 2, and Year 3, while the control group will receive routine follow-up care in Year 1 and Year 2, and will transition to receive the ACF intervention in Year 3. All clusters will eventually receive the ACF intervention. The main questions it aims to answer are: Does the ACF strategy decrease the prevalence of PTB among COPD patients compared with routine passive case-finding? What are the current prevalence and epidemiological characteristics of COPD-PTB comorbidity in primary care settings in Henan Province? Participants will: Receive ACF screening during their routine COPD follow-up visits in the intervention phase. Continue their usual COPD care as prescribed by their healthcare providers. If diagnosed with PTB through ACF screening, participants will be referred to designated hospitals for treatment in accordance with the national standardized tuberculosis treatment protocol.
Interventions
OTHERACF strategy
An ACF strategy integrating computer-aided diagnosis and GeneXpert MTB/RIF testing.
Sponsors
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Intervention model description
In Year 1, Arm A receive the intervention while Arm B serves as control. In Year 2, Arm A continues with the intervention, Arm B remains control. In Year 3, both Arm A and Arm B receive the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. aged 18 years or older; 2. residence in the local area for at least six months; 3. providing written informed consent to participate in the study.
Exclusion criteria
1. inability to provide informed consent or complete the questionnaire; 2. contraindications to CT scanning; 3. current pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prevalence of bacteriologically confirmed PTB | the third year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis delay time | Up to 36 months | Diagnosis delay is defined as the number of days from the date of the first screening test (e.g., CAD-assisted chest imaging) or the first medical examination for respiratory symptoms (for passive case-finding) to the date of bacteriologically-confirmed PTB diagnosis (positive Xpert MTB/RIF result). |
Outcome results
None listed