Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

NCT02330224 | Completed DMC

• 1 other identifier: 2013/663/E
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

High blood pressure (BP) is a serious public health problem responsible for heart attack, stroke and kidney failure. One in four adults in Singapore has hypertension. We propose a pilot study in 2 polyclinics in Singapore, 1 deliver a structured multi-component intervention and another usual care. A total of 100 adults with uncontrolled high blood pressure will be followed for 3 months. The intervention includes 1) algorithm-driven antihypertensive treatment for all patients using fixed-dose combination and lipid lowering for high risk patients, 2) motivational conversation for high risk patients; and 3) telephone based follow-ups of all patients by a team of physician supervised nurse practitioners and nurses. The change in BP will be compared between intervention and control groups. The structured care including the above mentioned components is likely to be more effective than usual care in lowering BP levels of patients with uncontrolled high blood pressure. Such a program is also likely to be more cost effective in terms of money spent for improving quality of patients' life. The findings of the pilot will inform the design of a larger cluster randomized trial in eight polyclinics in Singapore. If the main study is successful, the findings will be informative for policymakers to roll out intervention in all polyclinics and primary care centers across Singapore, and other countries with similar healthcare infrastructure.

Conditions

Hypertension; Cardiovascular Diseases

Keywords

Blood pressure; Lipids; Cardiovascular; Health services; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure from baseline to final follow-up at 3 months

  Baseline, month 3

Secondary Outcomes (5)

• Proportion of planned orientation sessions delivered

  Baseline

• Percent uptake of motivational interviewing sessions

  3 months

• Percent of data (laboratory and medication) retrieved from the polyclinic electronic database

  At month 3

• Proportion of blood pressure readings obtained at final follow-up

  At month 3

• Proportion of participants recruited

  Baseline

Study Arms (2)

Hypertension Management Intervention

EXPERIMENTAL

Multifaceted hypertension management intervention

Other: Hypertension Management Intervention

Usual Care

NO INTERVENTION

Control group

Interventions

Hypertension Management Intervention OTHER

The multifaceted intervention consists of three main components: 1. Structured treatment algorithm with fixed dose antihypertensives for high cardiovascular disease risk patients 2. Motivational conversation by nurses and nurse practitioners for high risk patients at baseline 3. Telephone based follow-up for all patients by nurses

Hypertension Management Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Singapore citizen and Permanent Resident
• Individuals visiting the recruiting polyclinic at least twice during the last 1 year
• Individuals with with previously diagnosed hypertension and uncontrolled blood pressure (Systolic BP 140 mmHg and above and diastolic BP 90 mmHg)

You may not qualify if:

• Individuals with active systemic illness including fever
• Individuals with recent hospitalization (i.e. during last 4 months),
• Individuals with clinically unstable heart failure (i.e. Ejection fraction \<20% or complaint of shortness of breath at rest)
• Individuals with advanced kidney disease (i.e. estimated Chronic kidney disease (CKD) -Epi glomerular filtration rate \<40 ml/min/1.73m2 or nephrotic range proteinuria (i.e. 3g/d or more))
• Individuals with known advanced liver disease (i.e. Child-Pugh Stage C)
• Individuals with pregnancy
• Individuals with any other major debilitating disease or
• Individuals with mental illness that precludes validity of informed consent

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead

Study Sites (2)

SingHealth Polyclinics, Geylang

Singapore, 389707, Singapore

Location

SingHealth Polyclinics, Tampines

Singapore, 529203, Singapore

Location

Related Publications (1)

• Jafar TH, Tan NC, Allen JC, Pradhan SS, Goh P, Tavajoh S, Keng FM, Chan J. Management of hypertension and multiple risk factors to enhance cardiovascular health - a feasibility study in Singapore polyclinics. BMC Health Serv Res. 2016 Jul 8;16:229. doi: 10.1186/s12913-016-1491-6.

  PMID: 27391818 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Tazeen H Jafar, MD, MPH

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

• Ngiap Chuan Tan, MBBS

  SingHealth Polyclinics, Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: December 28, 2014
• First Posted: January 1, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 1, 2015

Record last verified: 2014-12

Locations

SG (2)