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
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Behavioral: Intensification of Care Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|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|
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
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
- 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).
- 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..)
- 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.
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
|Family Health Units - Unique Health System|
|Blumenau, Santa Catarina, Brazil|
|Principal Investigator:||Ernani S Helena, PhD||Regional University of Blumenau|