HypertensionNCT02972619
Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health
A study testing Structured Multicomponent Intervention (MCI) in people with Hypertension and Cardiovascular Disease, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Disease
- What is being tested?
- Structured Multicomponent Intervention (MCI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Jan 2017to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
SingHealth Polyclinics (SHP)
Singapore, 150167
Dr Ngaip Chuan Tan, tan.ngiap.chuan@singhealth.com.sg
About this study
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
Read more
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.
- Conditions
- Hypertension, Cardiovascular Disease
- Being tested
- Structured Multicomponent Intervention (MCI)
- Keywords
- Blood Pressure, Lipids, Cardiovascular, Health Services, Hypertension
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Structured multicomponent intervention (MCI) Receives: Other: Structured Multicomponent Intervention (MCI) |
| Usual Care | No intervention | Control group receive usual care in the polyclinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure from baseline to final follow-up at 24 months
Measured: Baseline to 2 years
Secondary outcomes (13)
Change in serum LDL from baseline to final follow-up at 24 months
Measured: Baseline to 2 years
Proportion of hypertensive individuals with BP controlled to target or > 5 mm Hg decrease in systolic BP
Measured: Baseline to 2 years
Proportion of hypertensive individuals with decrease in LDL cholesterol by >0.4 mmol/L (>15 mg/dl).
Measured: Baseline to 2 years
Composite outcome of death or hospital admission due to Coronary heart disease (CHD), heart failure, or stroke
Measured: 2years
Individual outcomes of all-cause mortality, Cardiovascular disease (CVD) deaths, and hospital admission due to CHD, heart failure, or stroke
Measured: 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
Measured: Baseline to 2 years
Change in albuminuria from baseline to follow-up at 24 months
Measured: Baseline to 2 years
Change in estimated CKD-EPI GFR from baseline to follow-up at 24 months
Measured: Baseline - 2 years
Change in cardiovascular disease (CVD) risk score
Measured: 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
Measured: Baseline to follow-up 2 years
Change in lifestyle (diet, physical activity based on self-report) or BMI between groups
Measured: Baseline to 2 years
Change in systolic blood pressure from baseline to 12 months
Measured: Baseline to 1 year
Change in serum LDL cholesterol from baseline to 12 months
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start15 Jan 2017
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- SingHealth Polyclinics
- Responsible party
- Principal investigator, Professor Tazeen Jafar, Duke-NUS Graduate Medical School
- Investigators
- Dr Tazeen Jafar, MD, MPH, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972619
- Sponsor's protocol ID
- NMRC/CSA-SI/0005/2015
- Status last verified
- Jan 2018
- First submitted
- 20 Nov 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38606776Jafar 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.
PubMed 35696440Porhcisaliyan 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.
PubMed 34301679Allen 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.
PubMed 33468225Jafar 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.
PubMed 29540213
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Trial in Singapore Polyclinics
- ClinicalTrials.gov ID
- NCT02972619
- Acronym / sponsor ID
- NMRC/CSA-SI/0005/2015
- Conditions
- Hypertension, Cardiovascular Disease
- Keywords
- Blood Pressure, Lipids, Cardiovascular, Health Services, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- SingHealth Polyclinics
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Structured Multicomponent Intervention (MCI)Structured multicomponent intervention (MCI) |
| Usual Care | No intervention | –Control group receive usual care in the polyclinics |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Intervention |
Primary outcome
Change in Systolic Blood Pressure from baseline to final follow-up at 24 months
Time frame: Baseline to 2 years
13 secondary outcomes
Change in serum LDL from baseline to final follow-up at 24 months
Time frame: 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
Proportion of hypertensive individuals with decrease in LDL cholesterol by >0.4 mmol/L (>15 mg/dl).
Time frame: Baseline to 2 years
Composite outcome of death or hospital admission due to Coronary heart disease (CHD), heart failure, or stroke
Time frame: 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
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
Change in albuminuria from baseline to follow-up at 24 months
Time frame: Baseline to 2 years
Change in estimated CKD-EPI GFR from baseline to follow-up at 24 months
Time frame: Baseline - 2 years
Change in cardiovascular disease (CVD) risk score
Time frame: 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
Change in lifestyle (diet, physical activity based on self-report) or BMI between groups
Time frame: Baseline to 2 years
Change in systolic blood pressure from baseline to 12 months
Time frame: Baseline to 1 year
Change in serum LDL cholesterol from baseline to 12 months
Time frame: Baseline to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 38606776Chay 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.
- Derived from this study: PubMed 35696440Jafar 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.
- Derived from this study: PubMed 34301679Porhcisaliyan 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.
- Derived from this study: PubMed 33468225Allen 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.
- Derived from this study: PubMed 29540213Jafar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Tazeen Jafar, MD, MPH principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Multicomponent Intervention (MCI) in people with Hypertension and Cardiovascular Disease, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Tazeen Jafar, MD (+6566012582, tazeen.jafar@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure from baseline to final follow-up at 24 months (time frame: Baseline to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972619, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.