HypertensionNCT01560806
Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level
A study testing Commune Hypertension Management in people with Hypertension and Cardiovascular Risk Factor, run by Vietnam National Heart Institute at 1 site in Vietnam.
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). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Risk Factor, Lifestyle
- What is being tested?
- Commune Hypertension Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult people above 25
Who cannot join
- People deny to join the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quasi-experimental Intervention Study on Hypertension Management Combined With Comprehensive Healthy Lifestyle Promotion at Commune Level
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
Read the 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.
- Conditions
- Hypertension, Cardiovascular Risk Factor, Lifestyle
- Being tested
- Commune Hypertension Management
- Keywords
- hypertension, cardiovascular risk factor, lifestyle
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commune Hypertension ManagementOther
Also called Commune-based 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
| Study group | Role | What they receive |
|---|---|---|
| Conventional Healthcare services | No intervention | 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 |
| Commune Hypertension Management | Experimental | People with high blood pressure were managed in commune-based hypertension management programme Receives: Other: Commune Hypertension Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and after 3-year
Secondary outcomes (2)
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
Measured: Baseline and after 3-year
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
Measured: Baseline and after 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National Heart Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Son T. Pham, MD, Principal investigator, Vietnam National Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560806
- Sponsor's protocol ID
- VNHI-07-001
- Status last verified
- Mar 2012
- First submitted
- 19 Mar 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quasi-experimental Intervention Study on Hypertension Management Combined With Comprehensive Healthy Lifestyle Promotion at Commune Level
- ClinicalTrials.gov ID
- NCT01560806
- Acronym / sponsor ID
- VNHI-07-001
- Conditions
- Hypertension, Cardiovascular Risk Factor, Lifestyle
- Keywords
- hypertension, cardiovascular risk factor, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Vietnam National Heart InstituteOther government
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Healthcare services | No intervention | –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 |
| Commune Hypertension Management | Experimental | Other: Commune Hypertension ManagementPeople with high blood pressure were managed in commune-based hypertension management programme |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult people above 25
Key exclusion criteria (1 listed)
- People deny to join the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commune Hypertension ManagementAlso: Commune-based Hypertension ManagementPeople 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 | Commune Hypertension Management |
Primary outcome
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
2 secondary outcomes
Changes in prevalences of behavioral cardiovascular risk factors in intervention commune
Time frame: Baseline and after 3-year
Changes in average blood pressure in the population in intervention commune
Time frame: Baseline and after 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Son T. Pham, MD principal investigator
Vietnam National Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commune Hypertension Management in people with Hypertension and Cardiovascular Risk Factor, run by Vietnam National Heart Institute at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of people with high blood pressure receiving treatment and being controlled in intervention commune (time frame: Baseline and after 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.