Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial.

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.

Efficacy of a brief multifactorial adherence-based intervention on reducing the blood pressure of patients with poor adherence: protocol for a randomized clinical trial.

BACKGROUND: Lowering of blood pressure by antihypertensive drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to antihypertensive medications reduces their effectiveness and increases the risk of adverse events. In terms of relative risk reduction, an improvement in medication adherence could be as effective as the development of a new drug. METHODS/DESIGN: The proposed randomized controlled trial will include patients with a low adherence to medication and uncontrolled blood pressure. The intervention group will receive a multifactorial intervention during the first, third, and ninth months, to improve adherence. This intervention will include motivational interviews, pill reminders, family support, blood pressure self-recording, and simplification of the dosing regimen. MEASUREMENT: The primary outcome is systolic blood pressure. The secondary outcomes are diastolic blood pressure, proportion of patients with adequately controlled blood pressure, and total cost. DISCUSSION: The trial will evaluate the impact of a multifactorial adherence intervention in routine clinical practice. Ethical approval was given by the Ethical Committee on Human Research of Balearic islands, Spain (approval number IB 969/08 PI).

Set-up and pilot of a population cohort for the study of the natural history of COPD and OSA: the PULSAIB study.

AIMS: We describe the set-up of a population-based study focussed on respiratory conditions, and describe a pilot study - the PULmons SAns Illes Balears (PULSAIB) study - aimed at investigating the natural history of COPD, obstructive sleep apnoea (OSA), and other common chronic diseases. METHODS: A cross-sectional study was designed to survey two fieldwork areas, one rural and one urban, in the Balearic Islands, Spain. Tests conducted included a questionnaire, spirometry with post-bronchodilator (PBD) test, and portable respiratory polygraphy. RESULTS: We assessed all processes and tools to be used, and piloted them in 175 participants from Bunyola (rural) and 130 participants from the Son Pizà area (urban). Within this first cross-sectional assessment of the Balearic population aged 30 to 80 years, we report the prevalence of airflow limitation defined as a PBD FEV1/FVC ratio <0.7 and the prevalence of OSA defined as an apnoea-hypopnoea index (AHI) >10/hour. CONCLUSION: A cohort study in the Balearic population to investigate the natural history of COPD and OSA is feasible.

Effectiveness of intensive group and individual interventions for smoking cessation in primary health care settings: a randomized trial.

OBJECTIVES: Primary: To compare the effectiveness of intensive group and individual interventions for smoking cessation in a primary health care setting; secondary: to identify the variables associated with smoking cessation. METHODS: Three-pronged clinical trial with randomisation at the individual level. We performed the following: an intensive individual intervention (III), an intensive group intervention (IGI) and a minimal intervention (MI). Included in the study were smokers who were prepared to quit smoking. Excluded from the study were individuals aged less than 18 years or with severe mental conditions or terminal illnesses. The outcome measure was continued abstinence at 12 months confirmed through CO-oximetry (CO). The analysis was based on intention to treat. RESULTS: In total, 287 smokers were recruited: 81 in the III, 111 in the IGI, and 95 in the MI. Continued abstinence at 12 months confirmed through CO was 7.4% in the III, 5.4% in the IGI, and 1% in the MI. No significant differences were noted between III and MI on the one hand, and between IGI and MI on the other [RR 7.04 (0.9-7.2) and RR 5.1 (0.6-41.9), respectively]. No differences were noted between IGI and III [RR 0.7 (0.2-2.2)]. In multivariate analysis, only overall visit length showed a statistically significant association with smoking cessation. CONCLUSIONS: The effectiveness of intensive smoking interventions in this study was lower than expected. No statistically significant differences were found between the results of individual and group interventions. TRIAL REGISTRATION NUMBER: ISRCTN32323770.