Intensification of Care to Improve Adherence to Anti-hypertensives (HyperCare)
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.|
- Means difference and risk ratio between and within groups of adherence to treatment [ Time Frame: at basal and 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]It will be evaluated by two methods: pill count (proportion of pill taken as prescribed) and self-report using a structured validated questionnaire (proportion adherents in each group).
- Means difference and/or risk ratio between and within groups of clinical outcomes [ Time Frame: at basal and 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Usual provided care
Other: Usual Care
Usual care provided (medical and/or nurse consultation and medicines)
Other Name: Usual
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331369
|Contact: Ernani S Helena, PhD||55 47 3321 firstname.lastname@example.org|
|Contact: Nevoni G Damo, MSc||55 47 3321 email@example.com|
|Family Health Units - Unique Health System||Recruiting|
|Blumenau, Santa Catarina, Brazil|
|Contact: Sheila Santos, MSc firstname.lastname@example.org|
|Principal Investigator:||Ernani S Helena, PhD||Regional University of Blumenau|