COPD-PTB Screening Trial in Henan, China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACF strategy.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), TB - Tuberculosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Epidemiological Status and Intervention Technologies for COPD and Pulmonary Tuberculosis Comorbidity in Primary Care Settings in Henan Province, China
Overview
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
- Other ACF strategy
An ACF strategy integrating computer-aided diagnosis and GeneXpert MTB/RIF testing.
Primary outcome measures
- The prevalence of bacteriologically confirmed PTB [Time frame: the third year]
Secondary outcome measures (1)
- Diagnosis delay time [Time frame: Up to 36 months]
Eligibility criteria
Inclusion criteria
- aged 18 years or older;
- residence in the local area for at least six months;
- providing written informed consent to participate in the study.
Exclusion criteria
- inability to provide informed consent or complete the questionnaire;
- contraindications to CT scanning;
- current pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07706972 · 2025-244