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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04307875
Other study ID # coxs_2020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date September 30, 2022

Study information

Verified date April 2021
Source University Hospital Freiburg
Contact Alexander Supady, Dr. med. MPH
Phone +49761270
Email alexander.supady@universitaets-herzzentrum.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date September 30, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Blood pressure measurement (sphygmomanometer)
measuring blood pressure with standard sphygmomanometer
Blood glucose measurement
measuring blood glucose using standard measurement devices
Other:
psychometric tests
WHODAS 2.0, PHQ-9, CAPS-5

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
University Hospital Freiburg Gono Bishwabidyalay, Gonoshasthaya Kendra, Heidelberg University

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of hypertension Assessment of the prevalence of hypertension in the study groups 04-06/2020
Secondary Prevalence of diabetes mellitus Assessment of the prevalence of increased levels of fasting glucose in the study groups 04-06/2020
Secondary Mean systolic BP Mean systolic BP among adults aged 18 years and older. 04-06/2020
Secondary Mean fasting plasma glucose Mean fasting plasma glucose among adults aged 18 years and older. 04-06/2020
Secondary Successful BP treatment The proportion of adults aged = 18 years with hypertension who have a normal BP (systolic BP <140mmHg and a diastolic BP <90mmHg). 04-06/2020
Secondary Successful diabetes treatment The proportion of adults aged = 18 years with diabetes or pre-diabetes who have a HbA1c less than 7.0%. HbA1c will only be assessed in a small subgroup of participants (n = 100). 04-06/2020
Secondary Overweight and obesity The proportion of adults aged = 18 years being overweight (25 < BMI < 30) and obese (BMI > 30). 04-06/2020
Secondary WHODAS 2.0 Health and disability status within the study population as assessed by the WHO Disability Assessment Schedule (WHODAS 2.0). 04-06/2020
Secondary PHQ-9 The proportion of adults aged = 18 years with symptoms of depression assessed by the Patient Health Questionnaire (PHQ-9). 04-06/2020
Secondary CAPS-5 The proportion of adults aged = 18 years with symptoms of post-traumatic stress disorder assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 will only be done in a small subgroup of randomly selected participants (n = 100). 04-06/2020
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