Intensification of Care to Improve Adherence to Anti-hypertensives

NCT ID: NCT01331369

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-04-30

Brief Summary

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The aim of the study is to evaluate the effectiveness of a social-psychological intervention to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.

Detailed Description

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We will study two groups of 198 people with hypertension treated in ten health care units. One group will receive usual care dispensed in units (control). The other group (intervention) will be offered six individual assistance with health care worker physician or nurse) during the period of 9 months with a minimum interval of 30 days, plus 9 monthly visits structured by community health agents. Adherence will be measured in both groups at baseline and months 3, 6, 9 and 12, through validated questionnaire and pill count. Also evaluated clinical outcome measures (blood pressure, hospitalizations and deaths). The analysis will be done by intention to treat comparing adherence measures and clinical outcome between groups (Student t test and chi-square test) and within groups over time (paired t test and McNemar). It will be accepted p value \<0.05.

Conditions

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Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Usual care. It means routine medical care that include free demand consultation and free medicines.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual care provided (medical and/or nurse consultation and medicines)

Intervention

Intensification of care. Besides routine medical care that include free demand consultation and free medicines, subjects were invited to have 6 structured medical encounters based on a social-psychological approach. Doctors must follow a protocol to conduct the encounter that have around 30 minutes each.

Group Type EXPERIMENTAL

Intensification of Care

Intervention Type BEHAVIORAL

Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.

Interventions

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Intensification of Care

Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.

Intervention Type BEHAVIORAL

Usual Care

Usual care provided (medical and/or nurse consultation and medicines)

Intervention Type OTHER

Other Intervention Names

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Comprehensive Care Usual

Eligibility Criteria

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Inclusion Criteria

* persons with hypertension aged 18 years and older

Exclusion Criteria

* those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
* pregnants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacao de Apoio a Pesquisa de Santa Catarina

UNKNOWN

Sponsor Role collaborator

Universidade de Blumenau

OTHER

Sponsor Role lead

Responsible Party

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Ernani Tiaraju de Santa Helena

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ernani S Helena, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional University of Blumenau

Locations

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Family Health Units - Unique Health System

Blumenau, Santa Catarina, Brazil

Site Status

Countries

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Brazil

Related Links

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http://dgp.cnpq.br/dgp/espelhogrupo/4971570719283133

Research Group of Pharmacoepidemiology

Other Identifiers

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FURB 2010/01

Identifier Type: -

Identifier Source: org_study_id

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