Key result
Multifactorial adherence intervention fails to reduce systolic blood pressure over usual care in uncontrolled hypertension.
Why the study?
Does a brief multifactorial adherence-based intervention reduce 12-month systolic blood pressure compared with usual care in primary care patients with uncontrolled essential hypertension?
RCT (n=223)
Single-blind (patients and study nurses unblinded; outcome assessor, treating physicians, and statistician blinded)
Centralized computer-generated allocation sequence with a block size of eight
Yes
Does a brief multifactorial adherence-based intervention reduce 12-month systolic blood pressure compared with usual care in primary care patients with uncontrolled essential hypertension?
A primary care multifactorial adherence intervention combining motivational interviewing, pill reminders, family support, self-monitoring, and regimen simplification failed to significantly improve medication adherence or reduce blood pressure at 12 months in patients with uncontrolled hypertension.
Answers are grounded in this paper and cite their sources.
Does not support multifactorial adherence interventions for BP control in uncontrolled hypertension; challenges efficacy assumptions and warrants alternative strategies in trials.
BACKGROUND: Lowering blood pressure (BP) by antihypertensive (AHT) drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to AHT medications reduces their effectiveness and increases the risk of adverse events. OBJECTIVE: To evaluate the effectiveness of a multifactorial adherence-based intervention in a primary care setting in lowering BP. METHODS/DESIGN: Multicenter parallel randomized controlled trial. Thirty two nurses in 28 primary care centers of three Spanish regions. Patients aged 18-80 years, taking AHT drugs with uncontrolled BP (n=221) were randomized to a control group (usual care) or a multifactorial adherence-based intervention including nurse-led motivational interviews, pill reminders, family support, BP self-recording, and simplification of the dosing regimen by a pharmacist. MAIN OUTCOME MEASURES: The primary outcome was 12-month blinded measure of systolic BP (mean of three measurements). The secondary outcomes were 12-month diastolic BP and proportion of patients with adequately controlled BP. RESULTS: One hundred and fourteen patients were allocated to the intervention group and 109 to the control group. At 12 months, 212 (89%) participants completed the study. The systolic BP in the intervention group was 151.3 versus 153.7 in the control group (P=0.294). The diastolic BP did not differ between groups (83.4 versus 83.6). Of the patients in the control group, 9.2% achieved BP control versus a 15.8% in the intervention group. The relative risk for achieving BP control was 1.72 (95% confidence interval: 0.83-3.56). CONCLUSION: A multifactorial intervention based on improving adherence in patients with uncontrolled hypertension failed to find evidence of effectiveness in lowering systolic BP. TRIAL REGISTRATION: ISRCTN21229328.
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Leiva et al. (2014) conducted an RCT in Uncontrolled essential hypertension (n=223). Multifactorial adherence-based intervention (nurse-led motivational interviews, pillbox reminder, family support, BP self-recording, and pharmacist dosing simplification) vs. Usual care was evaluated on 12-month blinded measure of systolic blood pressure (mean of three measurements) (p=0.294). A multifactorial adherence-based intervention did not lower 12-month systolic blood pressure compared with usual care in uncontrolled hypertension.
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