Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

January 30, 2018 updated by: Professor Tazeen Jafar, Duke-NUS Graduate Medical School

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Structured multicomponent intervention (MCI)
Other: Structured Multicomponent Intervention (MCI)
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
No Intervention: Usual Care
Control group receive usual care in the polyclinics

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke-NUS Graduate Medical School

Collaborators

SingHealth Polyclinics

Investigators

  • Principal Investigator: Dr Tazeen Jafar, MD, MPH, Duke-NUS Graduate Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2017

Primary Completion (Anticipated)

March 15, 2020

Study Completion (Anticipated)

March 15, 2020

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRC/CSA-SI/0005/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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