Chronic Respiratory Disease Burden in Bangladesh
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|ClinicalTrials.gov Identifier: NCT04851808|
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
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.
|Condition or disease|
|Chronic Respiratory Disease COPD|
|Study Type :||Observational|
|Estimated Enrollment :||981 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Estimating the Burden of Chronic Respiratory Diseases (CRD) in Bangladesh Using the 4 Country Chronic Respiratory (4CCORD) Study Tools|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||September 30, 2021|
- Chronic Respiratory Diseases [ Time Frame: 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
- Maximum forced expiratory air volume in one second (FEV1) [ Time Frame: Aged 18 and above at the time of enrollment ]Lung Function of the Enrolled Participants shall be recorded. Maximum forced expiratory air volume in one second will be reported
- Forced Vital Capacity (FVC) [ Time Frame: Aged 18 and above at the time of enrollment ]Lung Function of the Enrolled Participants shall be recorded. Forced vital capacity of the lung will be reported
- Work Productivity due to Asthma and COPD [ Time Frame: Aged 18 and above at the time of enrollment ]The loss of work productivity in hours shall be measured for both Asthma and COPD
- Lung Function evaluation through FEV1/FVC ratio [ Time Frame: Aged 18 and above at the time of enrollment ]The lung function shall be measured. The ratio of maximum forced expiratory volume in one second (FEV1) and forced vital capacity shall be recorded.
- Height of the participant [ Time Frame: Aged 18 and above at the time of enrollment ]Height of the participant in meters
- Weight of the participant [ Time Frame: Aged 18 and above at the time of enrollment ]Weight of the Participant in kg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851808
|Contact: Samir K Saha, PhD, FRCPath||0088029104211 ext firstname.lastname@example.org|
|Contact: Mohammad S Islam, MSPH||0088029104211 ext email@example.com|
|Child Health Research Foundation||Recruiting|
|Dhaka, Bangladesh, 1207|
|Contact: Mohammad S Islam, MSPH 01787698256 firstname.lastname@example.org|
|Principal Investigator:||Aziz Sheikh, BSc, MBBS, MSc, MD, FRCGP,FRCP||Usher Institute, University of Edinburgh|
|Study Chair:||Hilary Pinnock, MB, ChB, MRCGP, MD||Usher Institute, University of Edinburgh|
|Study Chair:||Ee M Khoo, MBBS, FBSCH, MRCGP, FAMM, MD||University of Malaya: Kuala Lumpur, Wilayah Persekutuan, MY|
|Study Chair:||Sanjay Juvekar, MSc PhD||KEM University Hospital Pune, India|