Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02972619
• Other study ID #: NMRC/CSA-SI/0005/2015
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2016
• Last updated: January 30, 2018
• Start date: January 15, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: January 2018
• Source: Duke-NUS Graduate Medical School
• Contact: Dr Tazeen Jafar, MD
• Phone: +6566012582
• Email: tazeen.jafar[@]duke-nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Singapore	SingHealth Polyclinics (SHP)	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	SingHealth Polyclinics

Country where clinical trial is conducted

Singapore, 

Outcome

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