NCT02972619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

November 20, 2016

Last Update Submit

January 30, 2018

Conditions

HypertensionCardiovascular Disease

Keywords

Blood PressureLipidsCardiovascularHealth ServicesHypertension

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure from baseline to final follow-up at 24 months

    Baseline to 2 years

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Structured multicomponent intervention (MCI)

Other: Structured Multicomponent Intervention (MCI)

Usual Care

NO INTERVENTION

Control group receive usual care in the polyclinics

Interventions

Structured Multicomponent Intervention (MCI)OTHER

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

Intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SingHealth Polyclinics (SHP)

Singapore, 150167, Singapore

RECRUITING

Related Publications (5)

  • Chay J, Jafar TH, Su RJ, Shirore RM, Tan NC, Finkelstein EA. Cost-Effectiveness of a Multicomponent Primary Care Intervention for Hypertension. J Am Heart Assoc. 2024 Apr 16;13(8):e033631. doi: 10.1161/JAHA.123.033631. Epub 2024 Apr 12.

    PMID: 38606776DERIVED

  • Jafar TH, Tan NC, Shirore RM, Allen JC, Finkelstein EA, Hwang SW, Koong AYL, Moey PKS, Kang GC, Goh CWT, Subramanian RC, Thiagarajah AG, Ramakrishnan C, Lim CW, Liu J; for SingHypertension Study Group. Integration of a multicomponent intervention for hypertension into primary healthcare services in Singapore-A cluster randomized controlled trial. PLoS Med. 2022 Jun 13;19(6):e1004026. doi: 10.1371/journal.pmed.1004026. eCollection 2022 Jun.

    PMID: 35696440DERIVED

  • Porhcisaliyan VD, Wang Y, Tan NC, Jafar TH. Socioeconomic status and ethnic variation associated with type 2 diabetes mellitus in patients with uncontrolled hypertension in Singapore. BMJ Open Diabetes Res Care. 2021 Jul;9(1):e002064. doi: 10.1136/bmjdrc-2020-002064.

    PMID: 34301679DERIVED

  • Allen JC Jr, Halaand B, Shirore RM, Jafar TH; for SingHypertension Study Group. Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial. Trials. 2021 Jan 19;22(1):66. doi: 10.1186/s13063-020-05016-4.

    PMID: 33468225DERIVED

  • Jafar TH, Tan NC, Allen JC, Finkelstein EA, Goh P, Moey P, Quah JHM, Hwang SW, Bahadin J, Thiagarajah AG, Chan J, Kang G, Koong A. Management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: The SingHypertension cluster randomized trial. Trials. 2018 Mar 14;19(1):180. doi: 10.1186/s13063-018-2559-x.

    PMID: 29540213DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Dr Tazeen Jafar, MD, MPH

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Tazeen Jafar, MD

CONTACT

+6566012582tazeen.jafar@duke-nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2016

First Posted

November 23, 2016

Study Start

January 15, 2017

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)