Control of Blood Pressure and Risk Attenuation-rural Bangladesh, Pakistan, Sri Lanka, Feasibility Study

Hypertension Clinical Trial

— COBRA-BPS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341651
• Other study ID #: MR/L004224/1
• Status: Completed
• Phase: N/A
• First received: December 28, 2014
• Last updated: November 19, 2015
• Start date: August 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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. (10)Moreover, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Age= 40 years

2. Residing in the selected clusters

3. Hypertension defined either as:

1. persistently elevated BP (systolic BP =140 mm Hg or diastolic BP =90 mm Hg) from each set of 2 readings from 2 separate days

2. maintained on anti-hypertensive medications

4. Informed consent

Exclusion Criteria:

1. Bed-ridden individuals too ill to commute to the clinic

2. Individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)

3. Individuals that are mentally compromised and unable to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Multicomponent intervention
Multicomponent intervention is a combination of the following 1) community health worker (CHW)- led blood pressure (BP) screening and referral to provider, plus 2) home health education (HHE) adapted to the local diet by trained CHW plus 3) trained primary health center mid-level providers (MLP) and physicians using evidence-based treatment algorithm of BP lowering in all and lipid lowering for high risk, plus 4) process-based incentives

Locations

Country	Name	City	State
Bangladesh	Centre for Control of Chronic Diseases icddr,b	Dhaka	Mohakhali
Pakistan	Aga Khan University Hospital	Karachi
Sri Lanka	University of Kelaniya	Ragama

Sponsors (4)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	Aga Khan University, International Centre for Diarrhoeal Disease Research, Bangladesh, University of Kelaniya

Countries where clinical trial is conducted

Bangladesh,  Pakistan,  Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retention rate	proportion of hypertensive individuals followed up at 3 months in 3 countries	3 months	No
Secondary	Fidelity measure- Proportion of providers trained	proportion of targeted providers trained in 3 countries	3 months	No
Secondary	Fidelity measure- home health education sessions delivered	Proportion of planned home health education sessions delivered in 3 countries	3 months	No
Secondary	fidelity measure 3- physician management checklist collected	proportion of expected physician management checklist collected	3 months	No
Secondary	Baseline to follow-up change in systolic blood pressure level	within clusters intra-class correlation (95% CI) pre- to post- intervention change in systolic	3 months	No