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Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

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ClinicalTrials.gov Identifier: NCT02972619
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
SingHealth Polyclinics
Information provided by (Responsible Party):
Professor Tazeen Jafar, Duke-NUS Graduate Medical School

Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Disease Other: Structured Multicomponent Intervention (MCI) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Trial in Singapore Polyclinics
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

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



Primary Outcome Measures :
  1. Change in Systolic Blood Pressure from baseline to final follow-up at 24 months [ Time Frame: Baseline to 2 years ]

Secondary Outcome Measures :
  1. Change in serum LDL from baseline to final follow-up at 24 months [ Time Frame: Baseline to 2 years ]
  2. Proportion of hypertensive individuals with BP controlled to target or > 5 mm Hg decrease in systolic BP [ Time Frame: Baseline to 2 years ]
  3. Proportion of hypertensive individuals with decrease in LDL cholesterol by >0.4 mmol/L (>15 mg/dl). [ Time Frame: Baseline to 2 years ]
  4. Composite outcome of death or hospital admission due to Coronary heart disease (CHD), heart failure, or stroke [ Time Frame: 2years ]
  5. Individual outcomes of all-cause mortality, Cardiovascular disease (CVD) deaths, and hospital admission due to CHD, heart failure, or stroke [ Time Frame: 2 years ]
  6. 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 ]
  7. Change in albuminuria from baseline to follow-up at 24 months [ Time Frame: Baseline to 2 years ]
  8. Change in estimated CKD-EPI GFR from baseline to follow-up at 24 months [ Time Frame: Baseline - 2 years ]
  9. Change in cardiovascular disease (CVD) risk score [ Time Frame: Baseline - 2 years ]
  10. 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 ]
  11. Change in lifestyle (diet, physical activity based on self-report) or BMI between groups [ Time Frame: Baseline to 2 years ]
  12. Change in systolic blood pressure from baseline to 12 months [ Time Frame: Baseline to 1 year ]
  13. Change in serum LDL cholesterol from baseline to 12 months [ Time Frame: Baseline to 1 year ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972619


Contacts
Contact: Dr Tazeen Jafar, MD +6566012582 tazeen.jafar@duke-nus.edu.sg

Locations
Singapore
SingHealth Polyclinics (SHP) Recruiting
Singapore, Singapore, 150167
Contact: Dr Ngaip Chuan Tan       tan.ngiap.chuan@singhealth.com.sg   
Sponsors and Collaborators
Duke-NUS Graduate Medical School
SingHealth Polyclinics
Investigators
Principal Investigator: Dr Tazeen Jafar, MD, MPH Duke-NUS Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Tazeen Jafar, Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT02972619     History of Changes
Other Study ID Numbers: NMRC/CSA-SI/0005/2015
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Professor Tazeen Jafar, Duke-NUS Graduate Medical School:
Blood Pressure
Lipids
Cardiovascular
Health Services
Hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases