Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level
Primary Purpose
Hypertension, Cardiovascular Risk Factor, Lifestyle
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Commune Hypertension Management
Sponsored by

About this trial
This is an interventional health services research trial for Hypertension focused on measuring hypertension, cardiovascular risk factor, lifestyle
Eligibility Criteria
Inclusion Criteria:
- Adult people above 25
Exclusion Criteria:
- People deny to join the study
Sites / Locations
- Vietnam National Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional Healthcare services
Commune Hypertension Management
Arm Description
People with high blood pressure detected during screening survey or opportunistically during study period will be referred to receive the conventional health care services for hypertension at district hospital or local commune health station
People with high blood pressure were managed in commune-based hypertension management programme
Outcomes
Primary Outcome Measures
Proportion of people with high blood pressure receiving treatment and being controlled in intervention commune
Changes in proportion of treated and controlled hypertension after 3-years intervention compared to baseline
Secondary Outcome Measures
Changes in prevalences of behavioral cardiovascular risk factors in intervention commune
Changes in prevalence of behavioral cardiovascular risk factors after 3-years intervention compared to baseline
Changes in average blood pressure in the population in intervention commune
Changes in average systolic and diastolic blood pressure in the studied population after 3-year intervention
Full Information
NCT ID
NCT01560806
First Posted
March 19, 2012
Last Updated
March 20, 2012
Sponsor
Vietnam National Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT01560806
Brief Title
Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level
Official Title
Quasi-experimental Intervention Study on Hypertension Management Combined With Comprehensive Healthy Lifestyle Promotion at Commune Level
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vietnam National Heart Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A quasi-experimental study design was chosen to compare the model of hypertension management at commune-level with conventional management for people with high blood pressure in two communes (one for intervention versus one for reference).
A intervention model included the commune-based programme on hypertension management combined with comprehensive health promotion campaigns
Detailed Description
A quasi-experimental study design was chosen: two communes were purposively selected from Ba-Vi setting: Phu-Phuong for reference and Phu-Cuong for intervention communes A hypertension management programme and the nested comprehensive health promotion campaigns were implemented simultaneously in Phu-Cuong while nothing performed in Phu-Phuong except for local conventional healthcare services.
The health promotion campaigns aimed at smoking cessation, reduction of alcohol consumption, encourage of unsalted diet and physical activity, all of which targeted to every local inhabitants.
The hypertension management programme focused on monthly check-ups, drug delivery and individual lifestyle consultation, all of which targeted to hypertensives only.
Baseline cross-sectional survey was used to assess cardiovascular pattern in local community before intervention and recruit people with high blood pressure for the management programme in intervention commune Repeated cross-sectional surveys were used to evaluate the impacts of health promotion.
Cohort study on hypertensives was used to evaluate the impacts of the management programme.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Risk Factor, Lifestyle
Keywords
hypertension, cardiovascular risk factor, lifestyle
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Healthcare services
Arm Type
No Intervention
Arm Description
People with high blood pressure detected during screening survey or opportunistically during study period will be referred to receive the conventional health care services for hypertension at district hospital or local commune health station
Arm Title
Commune Hypertension Management
Arm Type
Experimental
Arm Description
People with high blood pressure were managed in commune-based hypertension management programme
Intervention Type
Other
Intervention Name(s)
Commune Hypertension Management
Other Intervention Name(s)
Commune-based Hypertension Management
Intervention Description
People with high blood pressure will be invited to join the management programme, with monthly check-up, delivery of multi anti-hypertensive drugs and lifestyle consultation.
Antihypertensive drugs delivered to local patients included (1) low-dose hypothiazide diuresis, (2) calcium channel blocker and (3) ACEI
Primary Outcome Measure Information:
Title
Proportion of people with high blood pressure receiving treatment and being controlled in intervention commune
Description
Changes in proportion of treated and controlled hypertension after 3-years intervention compared to baseline
Time Frame
Baseline and after 3-year
Secondary Outcome Measure Information:
Title
Changes in prevalences of behavioral cardiovascular risk factors in intervention commune
Description
Changes in prevalence of behavioral cardiovascular risk factors after 3-years intervention compared to baseline
Time Frame
Baseline and after 3-year
Title
Changes in average blood pressure in the population in intervention commune
Description
Changes in average systolic and diastolic blood pressure in the studied population after 3-year intervention
Time Frame
Baseline and after 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult people above 25
Exclusion Criteria:
People deny to join the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Son T. Pham, MD
Organizational Affiliation
Vietnam National Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vietnam National Heart Institute
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
12. IPD Sharing Statement
Links:
URL
http://www.huyetap.vn
Description
Information involved in the National Targeted Programme on Hypertension Prevention and Control
Learn more about this trial
Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level
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