HypertensionNCT06453382
Development and Testing of a Sub-district Specific Model of 'Whole-of-government', and 'Whole-of-society' Approaches for the Prevention and Control of Non-communicable Diseases in a Sub-district of Bangladesh
A study testing Behavioural change modification, Screening, NCD related knowledge practice and attitude in people with Hypertension and Diabetes, run by BRAC University at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes, Asthma
- What is being tested?
- Behavioural change modification, Screening, NCD related knowledge practice and attitude
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Sep 2022to 31 Aug 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Work within the area of study site
Who cannot join
- Do not work within the area of study site
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- Aims: To generate evidence of 'whole-of-government' and 'whole-of-society' approach for non-communicable diseases (NCD) prevention and control in Bangladesh
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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)
- Being tested
- Behavioural change modification, Screening, NCD related knowledge practice and attitude
- Keywords
- Non-communicable disease, Hypertension, Diabetes, Chronic respiratory disease, Whole of government, Whole of society
- Medical subject headings
- Hypertension, Diabetes Mellitus, Asthma, Pulmonary Disease, Chronic Obstructive, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural change modification, Screening, NCD related knowledge practice and attitudeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 'Whole of government' and 'whole of society' approach | Experimental | Sub-district level potential human resources engagement to control and prevent NCDs Receives: Behavioral: Behavioural change modification, Screening, NCD related knowledge practice and attitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BRAC University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malay K Mridha, PhD, Principal investigator, BRAC James P Grant School of Public Health, BRAC University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453382
- Sponsor's protocol ID
- IRB-10 November'22-045
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon request to the central contact person
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Sub-district Specific Model of 'Whole-of-government', and 'Whole-of-society' Approaches for the Prevention and Control of Non-communicable Diseases in a Sub-district of Bangladesh
- ClinicalTrials.gov ID
- NCT06453382
- Acronym / sponsor ID
- IRB-10 November'22-045
- Keywords
- Non-communicable disease, Hypertension, Diabetes, Chronic respiratory disease, Whole of government, Whole of society
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- BRAC UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Jun 2024 (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.
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.
Detailed description
- Aims: To generate evidence of 'whole-of-government' and 'whole-of-society' approach for non-communicable diseases (NCD) prevention and control in Bangladesh
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'Whole of government' and 'whole of society' approach | Experimental | Behavioral: Behavioural change modification, Screening, NCD related knowledge practice and attitudeSub-district level potential human resources engagement to control and prevent NCDs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Work within the area of study site
Key exclusion criteria (1 listed)
- Do not work within the area of study site
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 |
|---|---|---|
| Behavioural change modification, Screening, NCD related knowledge practice and attitudeThe 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. | Behavioural | 'Whole of government' and 'whole of society' approach |
Primary outcome
Number of trained healthcare providers in government healthcare facility in sub-district changes
Time frame: 2 years
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.
Number of equipment/logistics in government healthcare facility in sub-district changes
Time frame: 2 years
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.
Change in the proportion of physical activity, tobacco consumption, fruits and vegetable consumption among adolescents and adults
Time frame: 2 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.
Prevalence of NCDs reduced among the adults (>/= 18 years)
Time frame: 2 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.
Proportion of adherence to medication and lifestyle modification measures change among the people with NCDs
Time frame: 2 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.
The proportion of people with control of hypertension, lung function, and blood sugar increased
Time frame: 2 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.
The proportion of adults screened for cancer, diabetes, mental health disorders, hypertension and chronic respiratory diseases increased
Time frame: 2 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Yes. Data will be available upon request to the central contact person
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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.
Malay K Mridha, PhD principal investigator
BRAC James P Grant School of Public Health, BRAC University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural change modification, Screening, NCD related knowledge practice and attitude in people with Hypertension and Diabetes, run by BRAC University at 1 site in Bangladesh.
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 1 inclusion and 1 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of trained healthcare providers in government healthcare facility in sub-district changes (time frame: 2 years). The study lists 7 primary outcomes in all. 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 11 Jun 2024.