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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
Sponsor:
Collaborators:
University of Edinburgh
KEM Hospital Research Centre
Information provided by (Responsible Party):
Child Health Research Foundation, Bangladesh

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 981 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. Height of the participant [ Time Frame: Aged 18 and above at the time of enrollment ]
    Height of the participant in meters

  6. Weight of the participant [ Time Frame: Aged 18 and above at the time of enrollment ]
    Weight of the Participant in kg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult population above the age of 18 residing within the catchment of demographic surveillance system and resident of the Mirzapur upazilla will be taken as sample cohort for this research. The participants will be recruited from Mirzapur, a rural Upazila (sub-district) of Tangail district in Bangladesh; located 65 km north of Dhaka.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 )

Information from the National Library of Medicine

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


Contacts
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Contact: Samir K Saha, PhD, FRCPath 0088029104211 ext 171 samir@chrfbd.org
Contact: Mohammad S Islam, MSPH 0088029104211 ext 171 shahidul@chrfbd.org

Locations
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Bangladesh
Child Health Research Foundation Recruiting
Dhaka, Bangladesh, 1207
Contact: Mohammad S Islam, MSPH    01787698256    msohag10@gmail.com   
Sponsors and Collaborators
Child Health Research Foundation, Bangladesh
University of Edinburgh
KEM Hospital Research Centre
Investigators
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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
Publications of Results:
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Responsible Party: Child Health Research Foundation, Bangladesh
ClinicalTrials.gov Identifier: NCT04851808    
Other Study ID Numbers: CHRF002
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The personal information will be codified and the linkage data will not share with any other organization

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Child Health Research Foundation, Bangladesh:
Chronic Respiratory Disease
Spirometry
COPD Surveillance
Developing Countries
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases