NCT06453382

Brief Summary

Globally, non-communicable diseases (NCDs) are the leading cause of both mortality and morbidity. This intervention study aims to prevent and manage NCDs by adopting the World Health Organization's (WHO) comprehensive 'whole-of-government' and 'whole-of-society' approach. Although the Bangladesh government has devised a Multisectoral Action Plan (MAP) for NCD prevention and control, there's a need to operationalize these approaches at the sub-district level. This requires establishing a framework, implementing it, and assessing its effectiveness. To accomplish the study's objectives, the investigators will initially identify key stakeholders involved in NCD-related work or potentially able to contribute. Subsequently, investigators will qualitatively explore their potential involvement in NCD prevention and control, including their current roles and responsibilities, and how they could further contribute. Workshops will be conducted with these stakeholders to develop a tailored intervention model for NCD prevention and control at the sub-district level, utilizing the 'whole-of-government' and 'whole-of-society' approach. Following this, the sub-district specific model will be implemented, and the process will be documented. Finally, an evaluation will be conducted to assess the effectiveness of the sub-district specific model in achieving NCD-specific outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

September 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.7 years

First QC Date

May 14, 2024

Last Update Submit

June 8, 2024

Conditions

Keywords

Non-communicable diseaseHypertensionDiabetesChronic respiratory diseaseWhole of governmentWhole of society

Outcome Measures

Primary Outcomes (7)

  • Number of trained healthcare providers in government healthcare facility in sub-district changes

    We will perform a baseline service availability and readiness assessment of the healthcare facility using a tool adapted from WHO's harmonized health facility assessment tool. After that, at the end line, we again perform service availability and readiness assessments of those particular healthcare facilities.

    2 years

  • Number of equipment/logistics in government healthcare facility in sub-district changes

    We will perform a baseline service availability and readiness assessment of the healthcare facility using a tool adapted from WHO's harmonized health facility assessment tool. After that, at the end line, we again perform service availability and readiness assessments of those particular healthcare facilities.

    2 years

  • Change in the proportion of physical activity, tobacco consumption, fruits and vegetable consumption among adolescents and adults

    We will conduct baseline and end line community survey of adolescent and adult participants. From there, we will measure the change of the proportions of the NCD risk factors.

    2 years

  • Prevalence of NCDs reduced among the adults (>/= 18 years)

    We will conduct baseline and end line community survey of adolescent and adult participants. From there, we will measure the change of the proportions of the NCD risk factors.

    2 years

  • Proportion of adherence to medication and lifestyle modification measures change among the people with NCDs

    We will conduct baseline and end line community survey of adolescent and adult participants. From there, we will measure the change of the proportions of the NCD risk factors.

    2 years

  • The proportion of people with control of hypertension, lung function, and blood sugar increased

    We will conduct baseline and end line community survey of adolescent and adult participants. From there, we will measure the change of the proportions of the NCD risk factors.

    2 years

  • The proportion of adults screened for cancer, diabetes, mental health disorders, hypertension and chronic respiratory diseases increased

    We will conduct baseline and end line community survey of adolescent and adult participants. From there, we will measure the change of the proportions of the NCD risk factors.

    2 years

Study Arms (1)

'Whole of government' and 'whole of society' approach

EXPERIMENTAL

Sub-district level potential human resources engagement to control and prevent NCDs

Behavioral: Behavioural change modification, Screening, NCD related knowledge practice and attitude

Interventions

The investigators will provide periodic training regarding the control and prevention of NCDs to the stakeholders. The investigators will provide WHO-Package of Essential Non-Communicable Diseases (PEN) protocol training to the stakeholders involved in healthcare service delivery. The investigators will equip the government healthcare facilities with the equipment needed for the screening of NCDs. For the stakeholders who are not directly involved with healthcare service delivery, the investigators will train them about the 5 NCDs (diabetes, hypertension, chronic respiratory disease, cancer, and mental illness) and the 5 NCD risk factors (unhealthy diet, inadequate physical activity, tobacco cessation, alcohol cessation, and air pollution). The investigators will also share information, education, and communication (IEC) materials with the stakeholders, and then they will share the information with the community.

'Whole of government' and 'whole of society' approach

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Work within the area of study site

You may not qualify if:

  • Do not work within the area of study site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BRAC James P Grant School of Public Health

Dhaka, 1213, Bangladesh

Location

MeSH Terms

Conditions

HypertensionDiabetes MellitusAsthmaPulmonary Disease, Chronic ObstructiveNoncommunicable Diseases

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Malay K Mridha, PhD

    BRAC James P Grant School of Public Health, BRAC University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

June 11, 2024

Study Start

September 1, 2022

Primary Completion

May 31, 2024

Study Completion

August 31, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Data will be available upon request to the central contact person

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations