ACTRN12620000649910已完成4 期
A two-by-two factorial cluster randomised controlled trial evaluating the effectiveness of a stepped treatment algorithm for treating obstructive lung disease, and a behavioural intervention to reduce the prevalence of smoking among smokers in district health facilities in Vietnam.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,095
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion criteria for the chronic respiratory disease (CRD) component:
- •(a) Patients 12 years old and over, presenting to district health facilities; AND:
- •(b) Presents with at least one of cough, dyspnoea, wheeze or chest tightness, AND
- •(c) A history of at least one prior episode of respiratory symptoms requiring assessment by a health care facility (clinic, private doctor, pharmacy or hospital) in the past 24 months; AND
- •(d) Intends to be resident in the Province for the next 12 months
- •(e) Patients have a method of being contacted during follow-up (e.g. a personal telephone, or telephone of a relative) and
- •(f) Meets the definition for asthma or COPD, as defined by:
- •(i) Probable asthma: Score of three or more YES” responses (out of a total of 9) on the Asthma questionnaire) , OR
- •(ii) Airflow limitation: either pre-bronchodilator FEV1/FVC ratio < 70% OR (contraindicated or cannot be performed) Peak Expiratory Flow (PEF) <80% predicted at time of presentation;
- •Inclusion criteria for the smoking cessation (SC) component:
- •(a) Patients attending the selected health facility AND
- •(b) Aged 12 years and over; AND
- •(c) A current smoker (either occasional or daily); AND
- •(d) Intends to be resident in the Province for the next 12 months; AND
- •(e) Patients have a method of being contacted during follow-up (e.g. a personal telephone, or telephone of a relative)
排除标准
- •Exclusion criteria for screening:
- •(a)Patient cannot provide consent (e.g. due to confusion or dementia)
- •(b)The patient has respiratory failure (e.g. hypoxaemia requiring supplemental oxygen)
- •(c)The patient is haemodynamically unstable
- •(d)Patient currently has active tuberculosis
- •(e)The patient has a history of bronchiectasis, defined as daily cough and production of purulent sputum for at least 6 months.
- •(f)Patient has one of the following serious health conditions: aortic aneurysm, current cancer, an illness with a prognosis of <1 year
- •(g)Allergic to budesonide or formoterol
- •(h)Patient is currently pregnant
- •(i) Patients will not be enrolled if a probable alternative diagnosis explains the respiratory symptoms.
- •Exclusion criteria for the SC component:
- •(a) Unable to give informed consent, with difficulty with communication or severe mental illness.
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