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NCT01560806 Clinical Trial

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

Hypertension Clinical Trial

Official title:
Quasi-experimental Intervention Study on Hypertension Management Combined With Comprehensive Healthy Lifestyle Promotion at Commune Level

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01560806
Other study ID # VNHI-07-001
Secondary ID
Status Completed
Phase N/A
First received March 19, 2012
Last updated March 20, 2012
Start date December 2006
Est. completion date December 2009

Study information
Verified date March 2012
Source Vietnam National Heart Institute
Contact n/a
Is FDA regulated No
Health authority Vietnam: Ministry of Health
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 2400
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 25 Years and older
Eligibility Inclusion Criteria:

- Adult people above 25

Exclusion Criteria:

- People deny to join the study

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Vietnam Vietnam National Heart Institute Hanoi

Sponsors (1)
Lead Sponsor Collaborator
Vietnam National Heart Institute

Country where clinical trial is conducted

Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Baseline and after 3-year No
Secondary 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 Baseline and after 3-year No
Secondary 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 Baseline and after 3 years No
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