Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04595656 |
| Other study ID # |
HCR20007 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
October 31, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
University of Oxford |
| Contact |
Tom J Peto |
| Phone |
+66-802-187-460 |
| Email |
Tom[@]tropmedres.ac |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The SEACTN (South and Southeast Asian Community-based Trials Network) is a part of a
portfolio of programmes under the Wellcome Innovations Flagship 'Innovations for Impact in
Resource-limited Settings'. The flagship plan is to build the SEACTN infrastructure in
approximately 520 villages across three South and Southeast Asian countries (Bangladesh, Lao
PDR and Myanmar) to capture over 100,000 episodes and outcomes of rural febrile illness in
these remote and underserved communities. Mortality statistics in the populations covered by
SEACTN are considered as generally limited and unreliable and a recent assessment of vital
registration systems of these 3 countries showed a poor performance of the death registration
system. To support the goal of the flagship SEACTN program in defining the morbidity and
mortality burden of febrile illness and to strengthen the mortality data (causes of deaths
information) in study areas, the VA component is integrated as a part of project activities.
It will identify not only potential causes of deaths with a history of febrile illnesses, but
also all other CODs which occur in SEACTN network communities. The findings will also uncover
large gaps and challenges that impede delivery of primary health services in rural area of
the countries.
This observational multicountry study aims to conduct verbal autopsies in approximately 390
rural village communities in the SEACTN network in 5 countries; Bangladesh (in Cox's Bazar
and Bandarban districts), Lao PDR (in Phalanxay, Phin and Atsaphanthong districts in the
Province of Savannakhet), Thailand (Muang district of Chiang Rai province), Cambodia
(Battambang and Pailin provinces)and Thai-Myanmar border area (Kayin state, Myanmar). The
study populations are restricted to varying degrees from accessing adequate health services
due to geographical and financial factors. Since VA interviews will be carried out for all
deaths, the study will be able to point out capacity gaps in providing essential health
services at different levels of the health system as well as barriers in receiving healthcare
services. About 2,000 deaths or VA interviews are expected to be carried out over a 2-year
study period.
Study procedure: The death cases in villages will be notified by village health workers
(VHWs) or community health workers (CHWs) and also be checked through health facilities
records. The study respondent should be a close family member or a caregiver or a person who
closely attended to the deceased during the illness. VA instrument Questionnaires WHO 2016
version of validated electronic VA questionnaires will be used and there are three separate
VA forms for specific age groups: perinatal and neonatal mortality (death of a child under 4
weeks), child mortality (aged 4 weeks to 11 years), adult mortality (aged 12 years and over)
including maternal mortality. VA cause of death list The WHO VA cause of death list is used
to classify disease. The COD list is based on the international classification of diseases
(ICD-10) coding system.
The training of interviewers will be via online and face to face training sessions. The
training materials from research collaborators (University of Toronto, Canada) will be used
and adapted in local context. There will also be web based intensive courses for physicians
for coding and CoD certification. A VA needs an optimum recall period for high quality of
information. To keep the recall period as short as possible and to get reliable information,
field team will aim to visit the villages at 3-6 months intervals and conduct interviews with
the respondents of deceased persons to collect the information. The interview will take
approximately 30 to 45 minutes to complete using electronic format of questionnaires
installed in CommCare apps of SEACTN tablets after getting informed consent. Audio recordings
will be done to make sure for accurate records of the interviews and to complete the
narrative text section of the form. The investigators will also record the location of the
villages by GPS in order to define causes of deaths with a map.
For quality control of the interview process, 10 percent of interviews will be observed and
checked by field supervisors while conducting interviews. For quality control of coding and,
assessing the COD, two physicians will independently review the outcome of an interview, will
provide coding and formulate a COD. The COD identified by each physician will be recorded in
the database and if there is any disagreement, a third senior physician would be brought in
to adjudicate the result and sought for a solution.
