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