NCT01696318

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

September 22, 2012

Last Update Submit

January 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Change from baseline in Systolic Blood Pressure at 6 months

Study Arms (2)

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

Behavioral: Support for the Family Health Team

Interventions

Participation in physical educator, dietitian and pharmacist in primary health care

Educational program and individual care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hypertension (\> 140/90 mmHg)
  • Age \> 40 years
  • Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Carisi Polanczyc, PhD

    UFRGS/HMV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 22, 2012

First Posted

October 1, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations