HypertensionNCT04307875
Hypertension and Diabetes Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh
An observational study of Hypertension and Diabetes Mellitus, run by University Hospital Freiburg.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Post Traumatic Stress Disorder
- What is being tested?
- Blood pressure measurement (sphygmomanometer), Blood glucose measurement and psychometric tests
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Residing in one of the selected households (Camp 1E or Shamlapur municipality)
- Age ≥18 years
Who cannot join
- Inability to provide written informed consent
- Participant's unwillingness to participate
Trial locations and contacts
No sites are listed yet.
Alexander Supady, Dr. med. MPH contact
About this study
Official title: Hypertension and Diabetes Mellitus Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh
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.
Read the 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.
- Being tested
- Blood pressure measurement (sphygmomanometer), Blood glucose measurement, psychometric tests
- Keywords
- Rohingya refugees, Bangladesh, refugee camp
- Medical subject headings
- Hypertension, Diabetes Mellitus, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurement (sphygmomanometer)Diagnostic test
measuring blood pressure with standard sphygmomanometer
Blood glucose measurementDiagnostic test
measuring blood glucose using standard measurement devices
psychometric testsOther
WHODAS 2.0, PHQ-9, CAPS-5
| Study group | Role | What they receive |
|---|---|---|
| Rohingya refugee camp population | A sample of 1500 randomly selected individuals aged 18 years and above living in the Rohingya refugee camp 1E. Receives: Diagnostic Test: Blood pressure measurement (sphygmomanometer); Diagnostic Test: Blood glucose measurement; Other: psychometric tests | |
| Shamlapur refugee hosting community population | A sample of 1500 randomly selected individuals aged 18 years and above living in the refugee hosting community Shamlapur neighbouring the Rohingya refugee camps. Receives: Diagnostic Test: Blood pressure measurement (sphygmomanometer); Diagnostic Test: Blood glucose measurement; Other: psychometric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hypertension
Assessment of the prevalence of hypertension in the study groups
Measured: 04-06/2020
Secondary outcomes (9)
Prevalence of diabetes mellitus
Assessment of the prevalence of increased levels of fasting glucose in the study groups
Measured: 04-06/2020
Mean systolic BP
Mean systolic BP among adults aged 18 years and older.
Measured: 04-06/2020
Mean fasting plasma glucose
Mean fasting plasma glucose among adults aged 18 years and older.
Measured: 04-06/2020
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).
Measured: 04-06/2020
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).
Measured: 04-06/2020
Overweight and obesity
The proportion of adults aged ≥ 18 years being overweight (25 < BMI < 30) and obese (BMI > 30).
Measured: 04-06/2020
WHODAS 2.0
Health and disability status within the study population as assessed by the WHO Disability Assessment Schedule (WHODAS 2.0).
Measured: 04-06/2020
PHQ-9
The proportion of adults aged ≥ 18 years with symptoms of depression assessed by the Patient Health Questionnaire (PHQ-9).
Measured: 04-06/2020
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).
Measured: 04-06/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Oct 2021 (estimated)
- Primary completion15 May 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Gono Bishwabidyalay, Gonoshasthaya Kendra
- Responsible party
- Principal investigator, Dr. Alexander Supady, University Hospital Freiburg
- Investigators
- Kashem Shaikh, PhD, Principal investigator, Gono BishwabidyalayAlexander Supady, Dr. med. MPH, Principal investigator, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307875
- Sponsor's protocol ID
- coxs_2020
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension and Diabetes Mellitus Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh
- ClinicalTrials.gov ID
- NCT04307875
- Acronym / sponsor ID
- coxs_2020
- Keywords
- Rohingya refugees, Bangladesh, refugee camp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Heidelberg University, Gono Bishwabidyalay, Gonoshasthaya Kendra
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rohingya refugee camp population | – | Diagnostic Test: Blood pressure measurement (sphygmomanometer), Diagnostic Test: Blood glucose measurement, Other: psychometric testsA sample of 1500 randomly selected individuals aged 18 years and above living in the Rohingya refugee camp 1E. |
| Shamlapur refugee hosting community population | – | Diagnostic Test: Blood pressure measurement (sphygmomanometer), Diagnostic Test: Blood glucose measurement, Other: psychometric testsA sample of 1500 randomly selected individuals aged 18 years and above living in the refugee hosting community Shamlapur neighbouring the Rohingya refugee camps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Residing in one of the selected households (Camp 1E or Shamlapur municipality)
- Age ≥18 years
Key exclusion criteria (2 listed)
- Inability to provide written informed consent
- Participant's unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurement (sphygmomanometer)measuring blood pressure with standard sphygmomanometer | Diagnostic test | Rohingya refugee camp population, Shamlapur refugee hosting community population |
| Blood glucose measurementmeasuring blood glucose using standard measurement devices | Diagnostic test | Rohingya refugee camp population, Shamlapur refugee hosting community population |
| psychometric testsWHODAS 2.0, PHQ-9, CAPS-5 | Other | Rohingya refugee camp population, Shamlapur refugee hosting community population |
Primary outcome
Prevalence of hypertension
Time frame: 04-06/2020
Assessment of the prevalence of hypertension in the study groups
9 secondary outcomes
Prevalence of diabetes mellitus
Time frame: 04-06/2020
Mean systolic BP
Time frame: 04-06/2020
Mean fasting plasma glucose
Time frame: 04-06/2020
Successful BP treatment
Time frame: 04-06/2020
Successful diabetes treatment
Time frame: 04-06/2020
Overweight and obesity
Time frame: 04-06/2020
WHODAS 2.0
Time frame: 04-06/2020
PHQ-9
Time frame: 04-06/2020
CAPS-5
Time frame: 04-06/2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Supady, Dr. med. MPH contact
Kashem Shaikh, PhD principal investigator
Gono Bishwabidyalay
Alexander Supady, Dr. med. MPH principal investigator
University of Freiburg
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Diabetes Mellitus, run by University Hospital Freiburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Supady, Dr. med. MPH (+49761270 ext. 73790, alexander.supady@universitaets-herzzentrum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypertension (time frame: 04-06/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.