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