Control of Blood Pressure and Risk Attenuation- Bangladesh, Pakistan & Sri Lanka

Not Applicable

Conditions: Hypertension

Registration Number: SLCTR/2016/005

Lead Sponsor: Professor Tazeen Jafar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow up complete

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Age >40 years
2. Residing in the selected clusters in Puttalam District
3. Hypertension defined either as: a).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
b). Maintained on anti-hypertensive medications

Exclusion Criteria

1. Permanently bed-ridden individuals too ill to commute to the clinic
2. Pregnancy, individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure from baseline to final follow-up at two year post randomization (both measurements by independent data collectors who will be masked to randomization). <br><br>Primary cost-effectiveness measure<br><br>Incremental cost per mm Hg BP reduction from baseline to end of follow-up at two years post randomization and incremental cost per projected CVD disability adjusted life year (DALY) averted.<br> [At two years post randomization ]<br>

Secondary Outcome Measures

Name	Time	Method
BP controlled to target (SBP <140 mm Hg and DBP <90 mm Hg). <br>2. Composite outcome of death (all cause) <br>3. Hospital admission due to CHD, heart failure, or stroke <br>4. Change in antihypertensive medication adherence (Morisky score) <br>5. Change in BMI, dietary salt intake (urinary excretion) <br>6. Prevalence of current smokers, incident diabetes, serum lipid levels, and interheart CVD risk score from baseline to final follow-up at two year post randomization <br>7. Incidence of adverse outcomes (medication side effects, sick days absenteeism, low DALY between randomized groups)<br>8. Secondary cost-effectiveness measure: Incremental cost per DALY gained from baseline to end of follow-up.<br><br><br><br> [Two years post-randomization ]<br>