- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331369
Intensification of Care to Improve Adherence to Anti-hypertensives (HyperCare)
April 8, 2017 updated by: Ernani Tiaraju de Santa Helena, Universidade de Blumenau
Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
243
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Santa Catarina
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Blumenau, Santa Catarina, Brazil
- Family Health Units - Unique Health System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Usual care.
It means routine medical care that include free demand consultation and free medicines.
|
Usual care provided (medical and/or nurse consultation and medicines)
Other Names:
|
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.
|
Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
at basal and 3, 6, 9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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..)
|
at basal and 3, 6, 9 and 12 months
|
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.
|
at basal and 3, 6, 9 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ernani S Helena, PhD, Regional University of Blumenau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
March 29, 2011
First Submitted That Met QC Criteria
April 7, 2011
First Posted (Estimate)
April 8, 2011
Study Record Updates
Last Update Posted (Actual)
April 11, 2017
Last Update Submitted That Met QC Criteria
April 8, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FURB 2010/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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