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Intensification of Care to Improve Adherence to Anti-hypertensives (HyperCare)

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ClinicalTrials.gov Identifier: NCT01331369
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Fundacao de Apoio a Pesquisa de Santa Catarina
Information provided by (Responsible Party):
Ernani Tiaraju de Santa Helena, Universidade de Blumenau

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Medication Adherence Behavioral: Intensification of Care Other: Usual Care Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
Usual care. It means routine medical care that include free demand consultation and free medicines.
 Other: Usual Care
Usual care provided (medical and/or nurse consultation and medicines)
Other Name: Usual
Experimental: 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.
 Behavioral: Intensification of Care
Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.
Other Name: Comprehensive Care


Outcome Measures
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Primary Outcome Measures :
  1. Change in the proportion of people adherent to treatment - MMAS-8 [ Time Frame: at basal and 3, 6, 9 and 12 months ]
    It will be measure by "Moriski Medication Adherence Scale 8 item", translated and validated in Brazil. MMAS scores were trichotomized previously into the following 3 levels of adherence: high adherence (score, 8), medium adherence (score, 6 to <8), and low adherence (score, <6).


Secondary Outcome Measures :
  1. Change in the proportion of people adherent to treatment - QAM-Q [ Time Frame: at basal and 3, 6, 9 and 12 months ]
    It will be measure by "Questionário de Adesão a Medicamentos -Qualiaids" 3 item, an structured questionnaire developed and validated in Brazil. Non-adherence was accepted if respondent doesn't take 80% of his medicines or if he/she presents any errors on the process (time, jumps..)

  2. Means difference and/or risk ratio between and within groups of clinical outcomes [ Time Frame: at basal and 3, 6, 9 and 12 months ]
    It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331369


Locations
Brazil
Family Health Units - Unique Health System
Blumenau, Santa Catarina, Brazil
Sponsors and Collaborators
Universidade de Blumenau
Fundacao de Apoio a Pesquisa de Santa Catarina
Investigators
Principal Investigator: Ernani S Helena, PhD Regional University of Blumenau
More Information
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Additional Information:
Research Group of Pharmacoepidemiology  This link exits the ClinicalTrials.gov site

Responsible Party: Ernani Tiaraju de Santa Helena, Professor, Universidade de Blumenau
ClinicalTrials.gov Identifier: NCT01331369     History of Changes
Other Study ID Numbers: FURB 2010/01
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Ernani Tiaraju de Santa Helena, Universidade de Blumenau:
adherence
compliance
persistence
drop out
abandon

Additional relevant MeSH terms:
Antihypertensive Agents