NCT04307875

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

March 11, 2020

Last Update Submit

April 27, 2021

Conditions

Keywords

Rohingya refugeesBangladeshrefugee camp

Outcome Measures

Primary Outcomes (1)

  • Prevalence of hypertension

    Assessment of the prevalence of hypertension in the study groups

    04-06/2020

Secondary Outcomes (9)

  • Prevalence of diabetes mellitus

    04-06/2020

  • Mean systolic BP

    04-06/2020

  • Mean fasting plasma glucose

    04-06/2020

  • Successful BP treatment

    04-06/2020

  • Successful diabetes treatment

    04-06/2020

  • +4 more secondary outcomes

Study Arms (2)

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 measurementOther: 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 measurementOther: psychometric tests

Interventions

measuring blood pressure with standard sphygmomanometer

Rohingya refugee camp populationShamlapur refugee hosting community population

measuring blood glucose using standard measurement devices

Rohingya refugee camp populationShamlapur refugee hosting community population

WHODAS 2.0, PHQ-9, CAPS-5

Rohingya refugee camp populationShamlapur refugee hosting community population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDiabetes MellitusStress Disorders, Post-TraumaticDepression

Interventions

Blood Pressure DeterminationPsychometrics

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical ExaminationPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Kashem Shaikh, PhD

    Gono Bishwabidyalay

    PRINCIPAL INVESTIGATOR
  • Alexander Supady, Dr. med. MPH

    University of Freiburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Supady, Dr. med. MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Attending Physician

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

October 1, 2021

Primary Completion

May 15, 2022

Study Completion

September 30, 2022

Last Updated

April 28, 2021

Record last verified: 2021-04