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Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560806
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vietnam National Heart Institute
  Purpose

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


Condition Intervention
Hypertension Cardiovascular Risk Factor Lifestyle Other: Commune Hypertension Management

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Quasi-experimental Intervention Study on Hypertension Management Combined With Comprehensive Healthy Lifestyle Promotion at Commune Level

Further study details as provided by Vietnam National Heart Institute:

Primary Outcome Measures:
  • Proportion of people with high blood pressure receiving treatment and being controlled in intervention commune [ Time Frame: Baseline and after 3-year ]
    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 [ Time Frame: Baseline and after 3-year ]
    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 [ Time Frame: Baseline and after 3 years ]
    Changes in average systolic and diastolic blood pressure in the studied population after 3-year intervention


Enrollment: 2400
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional Healthcare services
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
Experimental: Commune Hypertension Management
People with high blood pressure were managed in commune-based hypertension management programme
Other: Commune Hypertension Management

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

Other Name: Commune-based Hypertension Management

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult people above 25

Exclusion Criteria:

  • People deny to join the study
  Contacts and Locations
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): NCT01560806


Locations
Vietnam
Vietnam National Heart Institute
Hanoi, Vietnam, 10000
Sponsors and Collaborators
Vietnam National Heart Institute
Investigators
Principal Investigator: Son T. Pham, MD Vietnam National Heart Institute
  More Information

Additional Information:
Responsible Party: Vietnam National Heart Institute
ClinicalTrials.gov Identifier: NCT01560806     History of Changes
Other Study ID Numbers: VNHI-07-001
First Submitted: March 19, 2012
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by Vietnam National Heart Institute:
hypertension
cardiovascular risk factor
lifestyle

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases