Chronic Respiratory Disease Burden in Bangladesh

NCT04851808 | Unknown DMC

• 1 other identifier: CHRF002
• Study Type: observational
• Target: 981
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Respiratory Disease; COPD

Keywords

Chronic Respiratory Disease; Spirometry; COPD Surveillance; Developing Countries

Outcome Measures

Primary Outcomes (1)

• Chronic Respiratory Diseases

  * 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

  Aged 18 and above at the time of enrollment

Secondary Outcomes (6)

• 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

• Lung Function evaluation through FEV1/FVC ratio

  Aged 18 and above at the time of enrollment

• Height of the participant

  Aged 18 and above at the time of enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Child Health Research Foundation, Bangladesh: lead
• University of Edinburgh: collaborator
• KEM Hospital Research Centre: collaborator

Study Sites (1)

Child Health Research Foundation

Dhaka, 1207, Bangladesh

RECRUITING

Related Publications (2)

• Braman SS. The global burden of asthma. Chest. 2006 Jul;130(1 Suppl):4S-12S. doi: 10.1378/chest.130.1_suppl.4S.

  PMID: 16840363 RESULT

• Lopez-Campos JL, Tan W, Soriano JB. Global burden of COPD. Respirology. 2016 Jan;21(1):14-23. doi: 10.1111/resp.12660. Epub 2015 Oct 23.

  PMID: 26494423 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aziz Sheikh, BSc, MBBS, MSc, MD, FRCGP,FRCP

  Usher Institute, University of Edinburgh

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Samir K Saha, PhD, FRCPath

CONTACT

0088029104211; samir@chrfbd.org

Mohammad S Islam, MSPH

CONTACT

0088029104211; shahidul@chrfbd.org

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 20, 2021
• Study Start: February 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)