Estimating the Burden of Chronic Respiratory Diseases (CRD) in Bangladesh Using the 4 Country Chronic Respiratory (4CCORD) Study Tools
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 981
- 试验地点
- 1
- 主要终点
- Chronic Respiratory Diseases
研究概览
简要总结
Chronic Respiratory Disease (CRD), particularly asthma and chronic obstructive pulmonary disorders (COPD) are leading causes of mortality and reduced quality of life due to its wide-reported association with other multi-morbidities.There is limited knowledge on the burden of CRD in the rural communities in Bangladesh due to poor awareness on the impact of CRD on quality of life and unavailability of diagnostic facilities due to weaker primary healthcare settings. The study aims to estimate the CRD burden in Bangladesh in a large representative population to draw the attention of policy makers to the creation of social awareness and improvement of primary healthcare infrastructure for respiratory disease in Bangladesh.
The study is a prospective observational one in nature. The study will be implemented in Mirzapur, a rural sub-district of Tangail district in Bangladesh within the period of February to May 2021. A total of 981 participants will be enrolled from the study. Verbal consent will be taken initially. Participants who are assessed to be COVID-19 negative will be invited for a visit to the mobile clinic following national health guidelines to perform the spirometry. The study team will provide an information sheet (written in local language) that describes the study aim and objectives with potential risk benefits to the participants. All participants will be enrolled through written consent and satisfactory response to the patient information sheet.
The Research Assistant (RA) will collect the relevant metadata such as demographics, information on risk factors, screening questionnaires relevant to asthma and COPD, reported health status and symptoms related to CRD etc. from the participant after obtaining the written consent. Data quality will be ensured by the Field Research Supervisor through checking all the collected information. The enrolled participants will undergo spirometry for the evaluation of their lung function. Spirometry will be collected by trained personnel and will be quality checked by an expert panel at CHRF. Repeated collection will take place in the event if the test results do not pass quality checking. Participant will also be invited to the study clinic within the next 10 days after assessment for any further clinical assessment that is deemed necessary by the study physician. The collected data and spirometry reports will be reviewed to evaluate the CRD patient in terms of their disease. The study will analyse the rate of CRD burden stratified by age, sex, and income group. The productivity loss will be measured in terms of work hours lost due to CRDs.
详细描述
BACKGROUND Chronic respiratory diseases (CRD), particularly asthma and chronic obstructive pulmonary disease (COPD) are leading causes of mortality and associated with multi-morbidity, leading to reduced productivity worldwide[1, 2]. We have limited data on the prevalence of CRD in Bangladesh, especially from the rural communities, where poor awareness and care-seeking behaviour, is compounded by the unavailability of diagnostic facilities and presence of weak primary health infrastructures. Determining the burden of CRD in these settings is thus challenging.
The RESPIRE 4-Country Chronic Respiratory Disease (4CCORD) pilot study, revealed a high prevalence of asthma (7%) and COPD (8%) in Bangladesh including many who were unaware of having mild airway obstruction and thus susceptible to CRD in future (unpublished data). Early diagnosis of these diseases could facilitate better primary prevention (abstaining from the exposure to harmful risk factors) and management to prevent deterioration.
The 4CCORD study aimed to validate the research tools and methodologies to detect the CRD cases at the community level. This study collected information from only 100 participants, thus lacked power drawing inference on the burden of CRD in the Bangladeshi population. With the support of RESPIRE and utilising the Child Health Research Foundation (CHRF) existing infrastructure, we want to survey an adequate sample to estimate the CRD burden in Bangladesh confidently. These data will help to draw the attention of the policymakers to these important diseases and create social awareness of CRD in Bangladesh.
STUDY AIM and OBJECTIVES To reduce the mortality and morbidity associated with CRD in Bangladesh by providing data on the health and economic burden of these diseases.
OBJECTIVES PRIMARY OBJECTIVE
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and above
- •Adults residing in the study area with an intention to stay within the auspices of the sites until the completion of the study
- •Adults who have consented to take part in the study
排除标准
- •Children or adolescents aged less than 18 years
- •Adults either outside of the study area or have no intention to stay within the study area
- •Adults unable to provide informed consent (e.g. severe cognitive impairment, recent (within one month) myocardial infarction, unstable cardiovascular status, aneurysms (abnormal dilatation of blood vessels), hemoptysis (blood in the cough), pneumothorax (abnormal trapping of air in the walls surrounding the lungs), recent eye, thoracic or abdominal surgery and facial palsy (paralysis of the face muscles))
- •Adults unable to complete the study questionnaires in their own language (trained study researchers will be involved to supervise completion and read the questions as necessary )
结局指标
主要结局
Chronic Respiratory Diseases
时间窗: Aged 18 and above at the time of enrollment
* Wheeze, Cough, Chest tightness and shortness of breath (at least one) present on most days for the last six months OR * Respiratory attacks having symptoms lasting than four weeks and occurring at least two times over the last two or more years
次要结局
- Maximum forced expiratory air volume in one second (FEV1)(Aged 18 and above at the time of enrollment)
- Forced Vital Capacity (FVC)(Aged 18 and above at the time of enrollment)
- Work Productivity due to Asthma and COPD(Aged 18 and above at the time of enrollment)
- Height of the participant(Aged 18 and above at the time of enrollment)
- Lung Function evaluation through FEV1/FVC ratio(Aged 18 and above at the time of enrollment)
- Weight of the participant(Aged 18 and above at the time of enrollment)