Clinical trial NCT04307875: Hypertension and Diabetes Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh
Official title: Hypertension and Diabetes Mellitus Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Diabetes Mellitus
Post Traumatic Stress Disorder
Depressive Symptoms
Keywords: Rohingya refugees
Bangladesh
refugee camp
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: Gono Bishwabidyalay
name: Gonoshasthaya Kendra
First posted: 2020-03-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be a random household sample from Camp 1E at the Cox's Bazar refugee camp area in Bangladesh and a random household sample from the Bangladesh host community in Shamlapur. Camp 1E is located on the northern end of the Cox's Bazar refugee camp area near Ukhia in south-eastern Bangladesh. Shamlapur is a village on the shores of the golf of Bengal, located about 25 kilometers south of Camp 1E. The population of Camp 1E is 40,000, half of them children under 18 years of age. The average household size is 4 people.

Brief summary: Due to a massive outbreak of violence against the Rohingya minority residing in the Rakhine State of Myanmar in late 2017, several hundred thousand Rohingya fled the country and sought a shelter in Bangladesh. Currently, in the refugee settlement areas east of the city of Cox's Bazar, close to 1 million Rohingya refugees live in refugee camps close to the municipalities of Ukhia and Shamlapur.

According to previous examinations, there is a serious burden of non-communicable diseases in Bangladesh. But little is known about the health status and the epidemiology of non-communicable diseases in the Rohingya refugee population in Bangladesh. Most importantly, scientific evidence on non-communicable disease in humanitarian emergencies is rather limited.

The aim of this study is to close this gap and to systematically assess the burden of hypertension and diabetes within the Rohingya refugee population in refugee camps in Bangladesh and in the host community in the Chittagong province. This assessment will help to design and to introduce community-based intervention strategies aiming to improve the population health status and reduce the disease burden.

Detailed description: Cardiovascular diseases are the predominant cause of death globally and in most low- and middle-income countries (LMICs). More than 70% of all global deaths are due to non-communicable diseases, almost half of them are caused by cardiovascular diseases. Diabetes mellitus as a major cardiovascular risk factor accounts for more than 1.5 million global deaths annually (almost 3% of all global deaths). In Bangladesh, according to WHO estimates, 30% of all deaths are due to cardiovascular diseases and 3% are due to diabetes. A recent study on more than 12,338 respondents revealed a 30.1% prevalence of hypertension and a 4.9% prevalence of diabetes among adults aged 35 years and above in Bangladesh.

Due to a massive outbreak of violence against people of the Rohingya minority in the Rakhine state of Myanmar in late 2017 several hundred thousand Rohingya fled the country and sought a refuge in the Chittagong province in south-eastern Bangladesh. These seemingly organized and coordinated attacks have been preceded by massive discrimination and recurrent violence against the Rohingya minority for many decades. Presently, close to 1 million Rohingya refugees settle in the refugee camps in the Chittagong province close to the municipalities of Ukhia and Shamlapur.

Scientific evidence on care of non-communicable diseases (NCDs) in humanitarian emergencies is very limited. A recent systematic review identified only five scientific studies, published between 1980 and 2014 on non-communicable diseases in humanitarian crises. Although many humanitarian organizations from Bangladesh and from abroad organize and support the provision of health services within the refugee camps, systematic evidence on the health status of the Rohingya refugee population is scarce - this is particularly true for chronic and non-communicable diseases.

As in the host community in Bangladesh, there will be a relevant burden of NCDs within the Rohingya refugee population. Furthermore, since the Rohingya have been discriminated for many years and access to health services was restricted for them, many of the diseased will be undiagnosed and untreated and a relevant number of individuals will suffer from long-term complications of untreated disease.

Chittagong province is one of the poorest regions in Bangladesh. Access to primary health services in Bangladesh is limited for many people due to various barriers, affordability being a major reason. A recent observation conducted by Gonoshasthaya Kendra, a project partner in the here presented study, revealed that the distance between place of residence and the nearest health facility and transportation costs are a major obstacle for people in Shamlapur to seek medical care. Data from previous nationwide epidemiologic studies do not sufficiently consider socioeconomic gradients within the Bangladesh population and therefore do not provide substantial information on hypertension and diabetes disease burden in the Rohingya refugee population and the host communities around the refugee camps.

The aim of this study is to systematically assess the burden of hypertension and diabetes mellitus within the Rohingya refugee population in the refugee camps in Bangladesh and in the host community in Chittagong province. This basic epidemiological information is essential for the planning, resource allocation and management of prevention and treatment strategies and programs for the respective populations. Considering the increasing relevance and burden of non-communicable and cardiovascular diseases particularly in low- and middle-income countries, a solid epidemiological data base is a mandatory prerequisite to address this global public health challenge. Therefore, this assessment will help to design and to introduce community-based intervention strategies aiming to improve the population health status and reduce the disease burden.

Eligibility criteria: Inclusion Criteria:

* Residing in one of the selected households (Camp 1E or Shamlapur municipality)
* Age ≥18 years

Exclusion Criteria:

* Inability to provide written informed consent
* Participant's unwillingness to participate

Primary outcomes:
measure: Prevalence of hypertension
timeFrame: 04-06/2020
Secondary outcomes:
measure: Prevalence of diabetes mellitus
timeFrame: 04-06/2020
measure: Mean systolic BP
timeFrame: 04-06/2020
measure: Mean fasting plasma glucose
timeFrame: 04-06/2020
measure: Successful BP treatment
timeFrame: 04-06/2020
measure: Successful diabetes treatment
timeFrame: 04-06/2020
measure: Overweight and obesity
timeFrame: 04-06/2020
measure: WHODAS 2.0
timeFrame: 04-06/2020
measure: PHQ-9
timeFrame: 04-06/2020
measure: CAPS-5
timeFrame: 04-06/2020
Other outcomes:
Locations:
Study officials:
affiliation: Gono Bishwabidyalay
name: Kashem Shaikh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Freiburg
name: Alexander Supady, Dr. med. MPH
role: PRINCIPAL_INVESTIGATOR
References: