Ignite Creation Date:
2024-05-06 @ 3:40 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02341651
Status:
COMPLETED
Last Update Posted:
2015-11-23
First Post:
2014-12-28
Brief Title:
Control of Blood Pressure and Risk Attenuation-rural Bangladesh Pakistan Sri Lanka Feasibility Study
Sponsor:
Duke-NUS Graduate Medical School
Organization:
Duke-NUS Graduate Medical School
Study Overview
Official Title:
Feasibility Study for a Cluster Randomized Trial on Integrated Primary Care Strategies to Reduce High Blood Pressure Control of Blood Pressure and Risk Attenuation-rural Bangladesh Pakistan Sri Lanka Feasibility Study
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COBRA-BPS
Brief Summary:
High blood pressure BP is the leading attributable risk for cardiovascular disease CVD In rural South Asia hypertension remains to be a significant public health issue with sub-optimal rates of case finding and management A trial to investigate integrated primary care strategies to control hypertension is planned Packaged interventions for the planned full-scale study are varying combinations of 1 home health education HHE by trained community health workers CHW 2 trained government primary health centre mid-level providers MLP led care and 3 trained private practitioners The goal of the full-scale study is to test which combination of the above interventions is the most effective in lowering blood pressure among adults with hypertension in rural communities In addition the full-scale study aims to quantify the incremental cost- effectiveness of each approach in terms of cost per projected cardiovascular disease CVD disability adjusted life-years DALYs averted
Detailed Description:
The rationale for conducting the feasibility study in 3 proposed South Asian countries is strong The South Asian countries are in a unique stage of epidemiological transition with a double burden of communicable and NCDs the latter increasing rapidly 2 These countries also share cultural habits and social structure with an extended family system and have largely similar population characteristics and health seeking behaviours 10Moreover the rural health system in all South Asian countries relies on cadres community health workers At the same time there are some differences Bangladesh and Pakistan have a high proportion of people living in extreme poverty purchasing power parity US 125day 496 and 226 respectively compared to Sri Lanka 14 which has relatively better development indicators in terms of life expectancy and literacy rates World Bank 2010 However age-standardized death rates from non-communicable diseases NCDs are uniformly high in all 3 countries The feasibility will allow direct comparison of some of these population individual and health systems characteristics among countries relevant for hypertension care Thus data from the feasibility will inform the future design of the trial
In order to optimize the trial design of the full study a mixed-methods feasibility study with quasi-experimental pre- and post- evaluation of triple approach with all 3 components of intervention survey of pharmacies and focus group discussions and individual in-depth interviews to better inform the strategies for the full-scale trial in rural settings in Bangladesh Pakistan and Sri Lanka
In order to optimize the trial design of the full study a mixed-methods feasibility study with quasi-experimental pre- and post- evaluation of triple approach with all 3 components of intervention survey of pharmacies and focus group discussions and individual in-depth interviews to better inform the strategies for the full-scale trial in rural settings in Bangladesh Pakistan and Sri Lanka
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None