Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06453382 |
| Other study ID # |
IRB-10 November'22-045 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
BRAC University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. Aims:
To generate evidence of 'whole-of-government' and 'whole-of-society' approach for
non-communicable diseases (NCD) prevention and control in Bangladesh
2. General objective:
The general objective of the research is to develop and test an sub-district-specific
multi-sectoral model of 'whole-of-government' and 'whole-of-society' approach for NCD
prevention and control in Birganj sub-district of Dinajpur district.
3. Specific Objectives:
- Identify government, non-government (NGO), and civil-society organizations (CSO)
relevant to the prevention and control of NCDs
- Define the roles and responsibilities of the government, NGO, and CSOs pertinent to
the prevention and control of NCDs
- Develop an sub-district specific intervention model of 'whole-of-government' and
'whole-of-society' approach for NCD prevention and control
- Implement the sub-district specific model and carry out a process documentation
- Evaluate the sub-district specific model with regard to NCD specific outcomes
4. Rationale In 2018, the Government of Bangladesh launched a multisectoral action plan
(MAP) in alignment with the World Health Organization (WHO) Global Action Plan for the
prevention and control of NCD. The core elements of this MAP for prevention and control
of NCD is 'whole-of-government' and 'whole-of-society' approach, universal health
coverage, cultural relevance, reduction of inequity, and life-course approach. The MAP
outlined four action areas: i. advocacy, leadership, and partnership, ii. health
promotion and risk reduction, iii. health system strengthening for early detection and
management of NCDs and their risk factors, and iv. surveillance, monitoring and
evaluation, and research. The MAP also provides guidelines for multi-sectoral
coordination mechanisms for the implementation of the action areas. In the MAP, the
guidelines for the formulation of sub-district level multisectoral committee and
functions of the committees have been described. However, to implement the
'whole-of-government' and the 'whole-of-society' approaches at the sub-district level,
there is a need to develop a model, implement the model and evaluate the effectiveness
of the model. Accordingly, in this study, the investigators propose developing a
sub-district specific 'whole-of-government' and 'whole-of-society' model to prevent and
control NCD and evaluate the model's effectiveness.
5. Methodology (Brief):
As NCD is a broad area, investigators will follow the WHO 5 by 5 framework (five
diseases and five risk factors) as a guide for implementing the research. Accordingly,
the focus of our research will be five risk factors: i. Tobacco consumption, ii. Alcohol
consumption, iii. Unhealthy diet, iv. Physical inactivity, and v. Air pollution, and
five diseases: i. Cardiovascular diseases, ii. Diabetes, iii. Cancers, iv. Chronic
respiratory diseases, and iv. Mental Health Disorders.
The study will be implemented in Birganj, an sub-district of Dinajpur district. As per
the 2011 census, Birganj sub-district has 317252 (159612 male and 157641 female)
population. In the sub-district, firstly, the investigators will identify the current
government, NGO, and CSOs and their possible roles for NCD prevention and control using
a landscape analysis. In the second step, in collaboration with the Directorate General
of Health Services, the investigators will define the NCD prevention and control roles
and responsibilities of the identified organizations. In the third step, investigators
will arrange workshops and meetings with the representatives from the organizations
(government: local government and sub-district administration, health, police,
education, women affairs, social affair, agriculture, fisheries, livestock, engineering;
NGOs, and civil society organizations (CSOs) and develop an sub-district specific model
of 'whole-of-government' and 'whole-of-society' approach for NCD prevention and control.
In collaboration with the government, NGO and CSO, and under direction from the
non-communicable diseases control (NCDC) of the Directorate General of Health Services
(DGHS), the investigators will implement the model for one year and evaluate the
effectiveness of the model on the indicators of both supply side, and demand side. On
the supply side, investigators will evaluate whether the involved organizations
developed an understanding of the whole-of-government' and 'whole-of-society' approach
and the service delivery and readiness of each of them improved or not. On the demand
side, the investigators will evaluate the changes in the NCD risk factors among the
adults and the adolescents, changes in the adherence to medication and lifestyle
measures among the people with NCDs, the changes in the proportion of population
screened for the five NCDs, and five risk factors mentioned above, and the changes in
the proportion of people with control over blood pressure, blood sugar, total
cholesterol, and lungs function. In this research, the investigators will administer
both qualitative and quantitative methodology. The evaluation of the model will be done
primarily through quantitative methods using a pre-post design. There will be a process
documentation component to document barriers and facilitators of the implementation so
that this model can be scaled up in other settings.
6. Ethical clearance: Ethical clearance for this study will be obtained from the
Institutional Review Board (IRB) of Bangladesh Rehabilitation Assistance Committee
(BRAC) James P Grant School of Public Health, BRAC University. Informed written consent
will be taken from each participant. Participation will be voluntary, and the
participants will have the right to withdraw at any time of the study.
7. Impact of the study in future research: Through this research, the investigators will
develop and test an sub-district specific model of 'whole-of-society' and
'whole-of-government' approach for prevention and control of NCD. If the model is
successful, there will be further research on the improvement and scalability of the
model.
8. Impact of the study at national level:
If the sub-district specific model of 'whole-of-society' and 'whole-of-government' approach
for prevention and control developed and tested through this study shows results, the model
can be scaled-up in other sub-districts of Bangladesh. In the long run, this research will
help the government of Bangladesh achieve the NCD related targets of the multi-sectoral
action plan, global action plan and the sustainable development goal (SDG) and relevant
targets (Goal 3, target 3.4, 3.5, 3.6, 3.8, 3.9, 3.A, and 3.C)
