Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

Study Overview
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Brief Summary
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Background: Hypertension is a serious public health problem responsible for significant mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30 years or older suffer from hypertension. Nearly half of these patients have uncontrolled hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims to evaluate the effectiveness, cost effectiveness and impact on medication adherence of a well-structured program using multicomponent intervention for hypertension control aimed at overall cardiovascular risk reduction among individuals with hypertension attending the polyclinics in Singapore, compared to existing services. Such a program is expected to be cost-effective in terms of improving hypertensive individuals' outcomes, and to be potentially scalable and sustainable. Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized to intervention or usual care (4 each) and followed up for 2 years post randomization Intervention: The structured multicomponent primary care program comprises of: 1) algorithm-driven antihypertensive treatment for all hypertensive individuals and using fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive individuals, 2) motivational conversation for high-risk hypertensive individuals, 3) Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on FDC antihypertensive medication Usual care: The participants attending polyclinics randomized to usual care will continue to receive treatment from the health providers according to existing practices. The hypertensive individuals will also continue to pay for the services (physician or nurse consultation) as per their existing model of reimbursement. Participants: A total of 1000 participants will be recruited, 125 from each of the 8 polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by randomization group). Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary outcome will be the change in systolic blood pressure from baseline to 2 years. Primary Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction from baseline to end of follow-up at two years post randomization; 2) incremental cost per projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline to final follow-up at two-year post. The impact of effect on adherence to antihypertensive and lipid medication will be measured using data on adherence obtained from polyclinic pharmacy records and clinic notes. An average of percent adherence to antihypertensive and lipid lowering will be computed as a composite score. The change in percent composite adherence to antihypertensive and lipid medications from baseline to follow up will be compared between the intervention and control groups.

Official Title
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Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Trial in Singapore Polyclinics

Conditions
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Hypertension, Cardiovascular Disease

Intervention / Treatment
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* Other: Structured Multicomponent Intervention (MCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years or older Singapore citizens or Permanent Residents Visiting the recruiting polyclinic at least twice during the last 1 year Individuals with a diagnosis of hypertension (systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg on two or more prior visits; physician diagnosed hypertension, or on antihypertensive medications) and uncontrolled blood pressure (systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg) Exclusion Criteria: Active systemic illness including fever, recent hospitalization (i.e. during last 4 months), Clinically unstable heart failure or advanced kidney disease {estimated CKD-Epi glomerular filtration rate (GFR) <40 ml/min/1.73m2 or nephrotic range proteinuria (i.e. 3g/d or more)}, Known liver disease, Pregnancy or breastfeeding Any other major debilitating disease or mental illness that precludes validity of informed consent

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Structured multicomponent intervention (MCI) | Other: Structured Multicomponent Intervention (MCI)<br>* Multicomponent Intervention (MCI) includes 1) algorithm-driven antihypertensive treatment for all hypertensive individuals using fixed-dose combination (FDC) and lipid lowering for high risk hypertensive individuals, 2) motivational conversation for high-risk hypertensive individuals and 3) telephone based follow-ups of all hypertensive individuals by a team of physician supervised nurse, and 4) discounts on FDC antihypertensive medications<br>|
| No Intervention: Usual Care<br>Control group receive usual care in the polyclinics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure from baseline to final follow-up at 24 months |  | Baseline to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum LDL from baseline to final follow-up at 24 months |  | Baseline to 2 years | 
| Proportion of hypertensive individuals with BP controlled to target or > 5 mm Hg decrease in systolic BP |  | Baseline to 2 years | 
| Proportion of hypertensive individuals with decrease in LDL cholesterol by >0.4 mmol/L (>15 mg/dl). |  | Baseline to 2 years | 
| Composite outcome of death or hospital admission due to Coronary heart disease (CHD), heart failure, or stroke |  | 2years | 
| Individual outcomes of all-cause mortality, Cardiovascular disease (CVD) deaths, and hospital admission due to CHD, heart failure, or stroke |  | 2 years | 
| Decrease of > 0.5 percent in glycated hemoglobin or change in proportion of hypertensive individuals with glycated hemoglobin <7% in hypertensive individuals with diabetes |  | Baseline to 2 years | 
| Change in albuminuria from baseline to follow-up at 24 months |  | Baseline to 2 years | 
| Change in estimated CKD-EPI GFR from baseline to follow-up at 24 months |  | Baseline - 2 years | 
| Change in cardiovascular disease (CVD) risk score |  | Baseline - 2 years | 
| Individual outcomes of change in a) diastolic BP and b) total cholesterol from baseline to end of follow-up at 24 months |  | Baseline to follow-up 2 years | 
| Change in lifestyle (diet, physical activity based on self-report) or BMI between groups |  | Baseline to 2 years | 
| Change in systolic blood pressure from baseline to 12 months |  | Baseline to 1 year | 
| Change in serum LDL cholesterol from baseline to 12 months |  | Baseline to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipids, Blood Pressure, Cardiovascular, Health Services, Hypertension