ClinicalTrials.gg
Status unknownNCT04307875Updated Apr 28, 2021

Hypertension and Diabetes Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh

An observational study in Hypertension, Diabetes Mellitus and Post Traumatic Stress Disorder, sponsored by University Hospital Freiburg. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by University Hospital Freiburg · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hypertension
  • Diabetes Mellitus
  • Post Traumatic Stress Disorder
  • Depressive Symptoms

Keywords

  • Rohingya refugees
  • Bangladesh
  • refugee camp
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 210 across 1,392 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University Hospital Freiburg is the lead sponsor of 94 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to provide written informed consent
  • Participant's unwillingness to participate
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Rohingya refugee camp population

    A sample of 1500 randomly selected individuals aged 18 years and above living in the Rohingya refugee camp 1E.

    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.

    Diagnostic Test: Blood pressure measurement (sphygmomanometer) · Diagnostic Test: Blood glucose measurement · Other: psychometric tests

Interventions

  • Diagnostic testBlood pressure measurement (sphygmomanometer)

    measuring blood pressure with standard sphygmomanometer

  • Diagnostic testBlood glucose measurement

    measuring blood glucose using standard measurement devices

  • Otherpsychometric tests

    WHODAS 2.0, PHQ-9, CAPS-5

06

What researchers measure

Primary outcomes

  1. Prevalence of hypertension

    Assessment of the prevalence of hypertension in the study groups

    Time frame: 04-06/2020

Secondary outcomes

  1. Prevalence of diabetes mellitus

    Assessment of the prevalence of increased levels of fasting glucose in the study groups

    Time frame: 04-06/2020

  2. Mean systolic BP

    Mean systolic BP among adults aged 18 years and older.

    Time frame: 04-06/2020

  3. Mean fasting plasma glucose

    Mean fasting plasma glucose among adults aged 18 years and older.

    Time frame: 04-06/2020

  4. 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).

    Time frame: 04-06/2020

  5. 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).

    Time frame: 04-06/2020

  6. Overweight and obesity

    The proportion of adults aged ≥ 18 years being overweight (25 \< BMI \< 30) and obese (BMI \> 30).

    Time frame: 04-06/2020

  7. WHODAS 2.0

    Health and disability status within the study population as assessed by the WHO Disability Assessment Schedule (WHODAS 2.0).

    Time frame: 04-06/2020

  8. PHQ-9

    The proportion of adults aged ≥ 18 years with symptoms of depression assessed by the Patient Health Questionnaire (PHQ-9).

    Time frame: 04-06/2020

  9. 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).

    Time frame: 04-06/2020

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2021; primary completion for May 2022, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2020
First posted
Mar 13, 2020
StartEst.
Oct 1, 2021
Primary completionEst.
May 15, 2022
CompletionEst.
Sep 30, 2022
Last update
Apr 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04307875
Lead sponsor
University Hospital Freiburg
Collaborators
Heidelberg University, Gono Bishwabidyalay, Gonoshasthaya Kendra
Responsible party
Dr. Alexander Supady (Principal Investigator, Attending Physician, University Hospital Freiburg) — Principal investigator
First posted
Mar 13, 2020
Start date
Oct 1, 2021 (estimated)
Primary completion
May 15, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Apr 28, 2021

Study contacts

Alexander Supady, Dr. med. MPH
Contact
alexander.supady@universitaets-herzzentrum.de
+49761270 ext. 73790
Kashem Shaikh, PhD
principal investigator · Gono Bishwabidyalay
Alexander Supady, Dr. med. MPH
principal investigator · University of Freiburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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