AVAPROMISE：一项通过行为改变提高原发性高血压患者依从性的随机临床试验。

AVAPROMISE: A randomized clinical trial for increasing adherence through behavioural modification in essential hypertension.

作者信息

Hamet Pavel, Campbell Norman, Curnew Greg, Eastwood Clive, Pradhan Ashish

机构信息

Centre Hospitalier de l'Universite de Montreal, University of Montreal, Montreal, Quebec;

出版信息

Exp Clin Cardiol. 2002 Winter;7(4):165-72.

PMID:19644587

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2716987/

Abstract

BACKGROUND

Patients with hypertension often do not adhere to their medications.

OBJECTIVE

To improve medication adherence in patients with essential hypertension by modifying their behaviours.

PATIENTS AND METHODS

From general practice settings, 4864 patients with essential hypertension were recruited and randomly assigned to receive the angiotensin receptor blocker irbesartan (Avapro) with (intervention group) or without (nonintervention group) a behavioural modification program (Avapromise) based on a model of change. Patients were followed up for 12 months. Patients were subgrouped based on their stage of change in the behavioural change continuum, and the intervention was tailored to address the needs of the particular subgroup. The primary efficacy measure was rate and time to discontinuation with irbesartan.

RESULTS

At the end of the study, there was no significant difference in the discontinuation rates between the intervention (25.4%, 95% CI 23.7 to 27.2) and nonintervention (25.5%, 95% CI 23.8 to 27.3) groups (P=0.94). The time to discontinuation (P=0.87) and the extrapolated rate of discontinuation estimated from the Kaplan-Meir curve (intervention 23.1%, 95% CI 21.3 to 24.8; nonintervention 23.5%, 95% CI 21.8 to 25.3) were not different between the groups.

CONCLUSIONS

This behavioural modification intervention based on a model of change was not efficacious at increasing rates of adherence in patients with essential hypertension in this setting. More individualized interventions may be required to increase adherence in this population.

摘要

背景

高血压患者常常不坚持服药。

目的

通过改变行为来提高原发性高血压患者的药物依从性。

患者与方法

从全科医疗环境中招募了4864例原发性高血压患者，并将其随机分为两组，一组接受基于改变模型的行为改变计划（阿伐普明思）并服用血管紧张素受体阻滞剂厄贝沙坦（安博维）（干预组），另一组只服用厄贝沙坦（非干预组）。对患者进行了12个月的随访。根据患者在行为改变连续体中的改变阶段进行亚组划分，并针对特定亚组的需求调整干预措施。主要疗效指标是厄贝沙坦停药率和停药时间。

结果

研究结束时，干预组（25.4%，95%可信区间23.7%至27.2%）和非干预组（25.5%，95%可信区间23.8%至27.3%）的停药率无显著差异（P=0.94）。两组之间的停药时间（P=0.87）以及根据Kaplan-Meir曲线估计的外推停药率（干预组23.1%，95%可信区间21.3%至24.8%；非干预组23.5%，95%可信区间21.8%至25.3%）也无差异。