HypertensionNCT01696318
Program for Cardiovascular Prevention and Randomized Clinical Trial
A study testing Support for the Family Health Team in people with Hypertension, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Support for the Family Health Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to May 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hypertension (> 140/90 mmHg)
- Age > 40 years
- Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro
Who cannot join
- Institutionalized individuals
- Patients with mental illness or disabling chronic illnesses
- Users of health services belonging to the supplementary health
- Individuals with life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
About this study
Official title: Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial
Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness.
- Conditions
- Hypertension
- Being tested
- Support for the Family Health Team
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support for the Family Health TeamBehavioural
Participation in physical educator, dietitian and pharmacist in primary health care
| Study group | Role | What they receive |
|---|---|---|
| Educational program | No intervention | Educational Program with Professional Physical Education, Pharmacist and Nutritionist |
| Educational program and individual care | Experimental | Educational program and individual care with professional Physical Education; Pharmacist and Nutritionist Receives: Behavioral: Support for the Family Health Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: Change from baseline in Systolic Blood Pressure at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Moinhos de Vento
- Responsible party
- Principal investigator, Fabiana Viegas Raimundo, Federal University of Rio Grande do Sul
- Investigators
- Carisi Polanczyc, PhD, Study director, UFRGS/HMV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696318
- Sponsor's protocol ID
- U1111-1134-6977
- Other IDs
- HMV - 680
- Status last verified
- Jan 2016
- First submitted
- 22 Sep 2012
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuhmmer R, Lazzaretti RK, Guterres CM, Raimundo FV, Leite LE, Delabary TS, Caon S, Bastos GA, Polanczyk CA. Effectiveness of multidisciplinary intervention on blood pressure control in primary health care: a randomized clinical trial. BMC Health Serv Res. 2016 Aug 31;16(1):456. doi: 10.1186/s12913-016-1703-0.
PubMed 27581760
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01696318
- Acronym / sponsor ID
- U1111-1134-6977
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital Moinhos de Vento
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Oct 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.
Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational program | No intervention | –Educational Program with Professional Physical Education, Pharmacist and Nutritionist |
| Educational program and individual care | Experimental | Behavioral: Support for the Family Health TeamEducational program and individual care with professional Physical Education; Pharmacist and Nutritionist |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of hypertension (> 140/90 mmHg)
- Age > 40 years
- Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro
Key exclusion criteria (4 listed)
- Institutionalized individuals
- Patients with mental illness or disabling chronic illnesses
- Users of health services belonging to the supplementary health
- Individuals with life expectancy less than 1 year
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 |
|---|---|---|
| Support for the Family Health TeamParticipation in physical educator, dietitian and pharmacist in primary health care | Behavioural | Educational program and individual care |
Primary outcome
Blood Pressure
Time frame: Change from baseline in Systolic Blood Pressure at 6 months
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 15 Jan 2016.
- Derived from this study: PubMed 27581760Kuhmmer R, Lazzaretti RK, Guterres CM, Raimundo FV, Leite LE, Delabary TS, Caon S, Bastos GA, Polanczyk CA. Effectiveness of multidisciplinary intervention on blood pressure control in primary health care: a randomized clinical trial. BMC Health Serv Res. 2016 Aug 31;16(1):456. doi: 10.1186/s12913-016-1703-0.
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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.
Carisi Polanczyc, PhD study director
UFRGS/HMV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support for the Family Health Team in people with Hypertension, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 4 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 15 Jan 2016. 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 Brazil. 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?
Blood Pressure (time frame: Change from baseline in Systolic Blood Pressure at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696318, which also lists 1 linked publication.
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 15 Jan 2016.