每日短信提醒在老年人药学服务中提高患者抗高血压药物依从性的效果（SPPA）：一项随机对照试验的研究方案

The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients' adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial.

作者信息

Haramiova Zuzana, Stasko Michal, Hulin Martin, Tesar Tomas, Kuzelova Magdalena, Morisky Donald M

机构信息

Department of Organization and Management of Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Kalinciakova 8, 832 32, Bratislava, Slovak Republic.

Research Institute for Child Psychology and Pathopsychology, Cyprichova 42, 831 05, Bratislava, Slovak Republic.

出版信息

Trials. 2017 Jul 18;18(1):334. doi: 10.1186/s13063-017-2063-8.

DOI:10.1186/s13063-017-2063-8

PMID:28720121

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5516377/

Abstract

BACKGROUND

Despite a variety of efficient and cost-effective antihypertensive medication, hypertension remains a serious health and economic burden. High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality. At the same time, Slovakia has alarmingly low patients' adherence to medication intake. Studies have shown the efficiency of short messaging service (SMS) reminders to improve patients' adherence and health outcomes at low costs. Since SMS is popular among Slovaks, this approach may be feasible also in Slovakia. The primary objective is to assess if daily SMS reminders of antihypertensive medication intake provided by pharmacists in addition to the standard pharmaceutical care increase the proportion of adherent older hypertensive ambulatory patients.

METHODS

The SPPA trial is a pragmatic randomized parallel group (1:1) trial in 300 older hypertensive patients carried out in community pharmacies in Slovakia. Trial pharmacies will be selected from all main regions of Slovakia. Trial intervention comprises daily personalized SMS reminders of medication intake embedded into usual pharmaceutical practice. The primary outcome is a combined adherence endpoint consisting of subjective self-reported medication adherence via the eight-item Morisky Medication Adherence Scale (MMAS-8) and objective pill count rate. Secondary outcomes include: change in the MMAS-8; comparison of adherence rates using pill count; change in systolic blood pressure; and patient satisfaction. Also, direct treatment costs will be evaluated and a cost-effectiveness analysis will be carried out.

DISCUSSION

The SPPA trial engages community pharmacists and mobile health (mHealth) technologies via evidence-based pharmaceutical care to efficiently and cost-effectively addresses current main healthcare challenges: high prevalence of hypertension; overconsumption of cardiovascular medicines; low adherence to medication treatment; and resulting uncontrolled blood pressure. The results may identify new possibilities and capacities in healthcare with low additional costs and high value to patients.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT03105687 . Registered on 07 March 2017.

摘要

背景

尽管有多种高效且具成本效益的抗高血压药物，但高血压仍然是一项严重的健康和经济负担。斯洛伐克共和国心血管药物的高消费量既未带来更好的高血压控制，也未使心血管死亡率显著降低。与此同时，斯洛伐克患者对药物摄入的依从性低得惊人。研究表明，短信提醒服务（SMS）能以低成本提高患者的依从性并改善健康结果。由于短信在斯洛伐克人中很受欢迎，这种方法在斯洛伐克可能也是可行的。主要目的是评估药剂师除提供标准药学服务外，每日发送抗高血压药物摄入的短信提醒是否能提高老年高血压门诊患者的依从比例。

方法

SPPA试验是在斯洛伐克社区药房对300名老年高血压患者进行的实用随机平行组（1:1）试验。试验药房将从斯洛伐克所有主要地区选取。试验干预包括在日常药学实践中嵌入每日个性化的药物摄入短信提醒。主要结局是一个综合依从性终点，包括通过八项Morisky药物依从性量表（MMAS - 8）主观自我报告的药物依从性和客观的药丸计数率。次要结局包括：MMAS - 8的变化；使用药丸计数比较依从率；收缩压的变化；以及患者满意度。此外，将评估直接治疗成本并进行成本效益分析。