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Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

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ClinicalTrials.gov Identifier: NCT02330224
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
Professor Tazeen Jafar, Duke-NUS Graduate Medical School

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.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Other: Hypertension Management Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-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 Pilot Trial in SingHealth Polyclinics, Singapore
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypertension Management Intervention
Multifaceted hypertension management intervention
Other: Hypertension Management Intervention

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

No Intervention: Usual Care
Control group



Primary Outcome Measures :
  1. Change in Systolic Blood Pressure from baseline to final follow-up at 3 months [ Time Frame: Baseline, month 3 ]

Secondary Outcome Measures :
  1. Proportion of planned orientation sessions delivered [ Time Frame: Baseline ]
    Orientation training session for treatment algorithm and motivational counseling will be organized in multiple lunch-time sessions. The number of orientation sessions planned will be denominator and the number of sessions successfully delivered will be numerator. Target is 100%.

  2. Percent uptake of motivational interviewing sessions [ Time Frame: 3 months ]
  3. Percent of data (laboratory and medication) retrieved from the polyclinic electronic database [ Time Frame: At month 3 ]
    The total number of participants received the laboratory tests and prescribed medications will be denominators and the number of participants whose data are successfully retrieved from electronic database will be numerator. Target is 98% of data retrieved.

  4. Proportion of blood pressure readings obtained at final follow-up [ Time Frame: At month 3 ]
    Total number of participants enrolled will be denominator. Number of participants whose blood pressure readings are successfully obtained at final visit (3 months from baseline) will be numerator. Target is 80%.

  5. Proportion of participants recruited [ Time Frame: Baseline ]


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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 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)

Exclusion Criteria:

  • 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

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): NCT02330224


Locations
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Singapore
SingHealth Polyclinics, Geylang
Singapore, Singapore, 389707
SingHealth Polyclinics, Tampines
Singapore, Singapore, 529203
Sponsors and Collaborators
Duke-NUS Graduate Medical School
Investigators
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Principal Investigator: Tazeen H Jafar, MD, MPH Duke-NUS Graduate Medical School
Principal Investigator: Ngiap Chuan Tan, MBBS SingHealth Polyclinics, Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Tazeen Jafar, Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT02330224     History of Changes
Other Study ID Numbers: 2013/663/E
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: December 2014
Keywords provided by Professor Tazeen Jafar, Duke-NUS Graduate Medical School:
Blood pressure
Lipids
Cardiovascular
Health services
Hypertension
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases