Defining Causes of Deaths in South and Southeast Asia

NCT04595656 | Completed

• 1 other identifier: HCR20007
• Study Type: observational
• Target: 3,413
• Locations: 5 countries
• Sites: 5

Brief Summary

Brief Summary: Mortality data are important in low and middle-income countries to assess the population health status and trends. Mortality statistics in the populations of Bangladesh, Myanmar and Lao PDR are considered as generally limited and a recent assessment of vital registration systems of those countries reported a poor performance of the death registration system. Majority of deaths occur at home in rural area of those countries without cause of death assigned. To address this problem, the investigators will use verbal autopsy (VA) method developed by WHO to ascertain the cause of a death based on an interview with a family member or caregiver of deceased person to obtain information about causes of death in study rural communities. Death related to a specific cause will be defined by ICD-10 codes and described as primary, secondary or underlying COD. The study is planned to conduct in approximately 390 rural village communities covered by Southeast Asia clinical trial network (SEACTN) network in proposed 3 countries. The study findings will help establish a better understanding in signs, symptoms, medical history and circumstances preceding death; prioritize future interventions for early and effective diagnostics and treatment for diseases and how to keep mortality surveillance ongoing in study rural settings. This study is funded by Welcome Trust. Welcome Trust grant reference number is \[215604/Z/19/Z\].

Conditions

Cause of Mortality; Cause of Child Death; Cause of Maternal Death; Cause of Adult Death; Cause of Neonatal Death

Keywords

Death; fatal outcome; interview; mortality; pathologic process

Outcome Measures

Primary Outcomes (1)

• ~2,000 deaths classified according to ICD-10 classification

  Classification of causes of deaths by verbal autopsy methods in rural areas of South and Southeast Asia: Based on information from the VA interview, the study physicians will identify possible causes of death. Death related to a specific cause will be defined by ICD-10 codes and described as primary, secondary or underlying COD.

  18-20 months recruitment

Secondary Outcomes (5)

• Age standardized mortality rate, gender specific CODs

  18-20 months of recruitment period

• Spatiotemporal mortality by causes

  18-20 months of recruitment period

• Numbers of deaths with acute febrile illness history, to inform potential diagnostic, treatment, and referral interventions

  18-20 months of recruitment period

• Proportion of deaths with acute febrile illness history.

  18-20 months of recruitment period

• Number of causes of death reported from VA and other available sources (local treatment records, diagnoses from other SEACTN components)

  18-20 months of recruitment period

Interventions

verbal autopsy interview OTHER

The study involves filling of verbal autopsies for deaths in SEACTN villages. This is an observational study being conducted as a substudy of rural febrile project of SEACTN program.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The respondent should be a close family member or a caregiver or a person who closely attended to the deceased during the illness (e.g. the mother in the case of an infant death, the spouse in case of an adult death, the son/daughter in the case of deaths among the elderly and an adult female relative in case of maternal deaths); and the respondent's educational status and communication skills. If needed, another household member or neighbor can help the primary respondents for specific details.

You may qualify if:

• All adult participants whose family member's death occurred in SEACTN villages within 12 months.

You may not qualify if:

• Participants whose family member's death occurred outside of SEACTN villages or deaths more than 12months
• Respondents who are not providing informed consent

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (5)

Building Resources Across Communities (BRAC)

Dhaka, Bangladesh

Location

villages in Thai-Myanmar border

Myawady, Kayin State, Burma

Location

Action for Health Development (AHEAD)

Battambang, Cambodia

Location

Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)

Vientiane, Laos

Location

Chiangrai Clinical Research Unit (CCRU)

Chiang Rai, Thailand

Location

Related Links

• Publication Results

MeSH Terms

Conditions

Death; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 20, 2020
• Study Start: September 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 18, 2026

Record last verified: 2026-01

Locations

TH (1); CA (1); LA (1); BU (1); BA (1)