NCT04851808

Chronic Respiratory Disease Burden in Bangladesh

Status unknown Last updated 20 April 2021

What this trial tests

trial in Chronic Respiratory Disease in 981 participants. Status unknown.

Timeline

1 February 2021

Primary endpoint
31 May 2021

30 September 2021

Quick facts

Lead sponsor	Child Health Research Foundation, Bangladesh
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	981
Start date	1 February 2021
Primary completion	31 May 2021
Estimated completion	30 September 2021
Sites	1 location across Bangladesh

Conditions studied

• Chronic Respiratory Disease — all drugs for Chronic Respiratory Disease →
• COPD — all drugs for COPD →

Sponsor

Child Health Research Foundation, Bangladesh

Who can join

18 and older, any sex, with Chronic Respiratory Disease or COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.