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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02330224 |
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Date of registration:
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28/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health
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Scientific title:
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Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Pilot Trial in SingHealth Polyclinics, Singapore |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02330224 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Ngiap Chuan Tan, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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SingHealth Polyclinics, Research |
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Name:
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Tazeen H Jafar, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke-NUS Graduate Medical School, Singapore |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Cardiovascular Diseases
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Intervention(s)
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Other: Hypertension Management Intervention
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Primary Outcome(s)
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Change in Systolic Blood Pressure from baseline to final follow-up at 3 months
[Time Frame: Baseline, month 3]
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Secondary Outcome(s)
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Proportion of planned orientation sessions delivered
[Time Frame: Baseline]
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Percent of data (laboratory and medication) retrieved from the polyclinic electronic database
[Time Frame: At month 3]
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Proportion of blood pressure readings obtained at final follow-up
[Time Frame: At month 3]
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Proportion of participants recruited
[Time Frame: Baseline]
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Percent uptake of motivational interviewing sessions
[Time Frame: 3 months]
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Secondary ID(s)
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2013/663/E
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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