Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka

Hypertension Clinical Trial

— COBRA-BPS  

Official title:

Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02657746
• Other study ID #: MR/N006178/1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: March 2020

Study information

• Verified date: October 2019
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: 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. The goal of the full-scale study is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies on lowering blood pressure among adults with hypertension in rural communities in Bangladesh, Pakistan, and Sri Lanka.

Methods/Design: The mixed-methods, stratified cluster randomized controlled trial

Intervention: The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.

Usual care: Will comprise existing services in the community without any additional training.

Participants: The trial will be conducted on 2550 individuals aged 40 years or older with hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550 individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg) will be selected, 14 from each community, to investigate the effect of MCI on results from ambulatory BP monitoring.

Qualitative component: Stakeholders including policymakers, district managers, and community health workers, GPs, hypertensive individuals and family members in the identified clusters will be surveyed.

Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24 months post randomization. The cost effectiveness outcome is the incremental cost of MCI per unit reduction in BP over the two year time period and in terms of incremental cost per CVD DALYs averted.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2550
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Main study:

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 last 2 of 3 readings from 2 separate days

2. maintained on anti-hypertensive medications

4. Informed consent

Exclusion Criteria:

1. Permanently bed-ridden individuals too ill to commute to the clinic

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

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

Sub-study:

1) fulfill all criteria of main study and, 2) Persistently elevated systolic BP >160 mm Hg or diastolic BP >100 mm Hg from each set of 2 readings from 2 separate days

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Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• multi-component interventions
The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization.		Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization
Secondary	Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm		at 6-month intervals over 24 months
Secondary	Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke		24 months
Secondary	Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up		24 months
Secondary	Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score)		24 months
Secondary	Height and weight measurements:change in body mass index ( BMI)		24 months
Secondary	questionnaire:change dietary salt intake (urinary excretion)		24 months
Secondary	Questionnaire:change in prevalence of current smokers		24 months
Secondary	Questionnaire:incident diabetes		24 months
Secondary	Lipid panel: change in serum lipid levels		24 months
Secondary	questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score		24 months
Secondary	Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups).		24 months
Secondary	Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR)		24 months
Secondary	Urine albumin:Change in urine albumin		24 months
Secondary	24 hours mean diastolic BP	Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline	24 months
Secondary	Daytime SBP/DBP	secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline	24 months
Secondary	Night time SBP/DBP	Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline	24 months
Secondary	Dipping Pattern	Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline	24 months
Secondary	24 hour BP variability	Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline	24 months
Secondary	Questionnaire and EQ-5D-5L:Incremental cost per mm Hg BP reduction from baseline to end of follow-up at two years post randomization and incremental cost per projected cardiovascular disease ( CVD) disability adjusted life year (DALY) averted		information on healthcare cost will be collected at baseline and 24 months
Secondary	incremental cost per mm Hg BP reduction from baseline to end of follow-up at 2 years post-randomization and incremental cost per projected CVD disability-adjusted life year (DALY) averted		24 months