Buis Lorraine R, Artinian Nancy T, Schwiebert Loren, Yarandi Hossein, Levy Phillip D
University of Michigan, Department of Family Medicine, Ann Arbor, MI, United States.
JMIR Res Protoc. 2015 Jan 2;4(1):e1. doi: 10.2196/resprot.4040.
Hypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population.
The purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN.
In Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention.
Although data collection is now complete, data analysis from the two pilot RCTs is still ongoing and results are expected in 2015.
This study was designed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department settings. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes, particularly within underserved urban minorities.
Clinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ).
高血压(HTN)是美国主要的公共卫生问题,近7800万20岁及以上的美国人患有此病。此外,高血压是心脏病和中风的关键风险因素。非裔美国人承受着不成比例的高血压负担,与年龄匹配的白人相比,其患病率更高、疾病严重程度更高、发病更早,且高血压相关并发症更多。高血压治疗的药物依从性较差,据估计,只有约一半的高血压患者坚持规定的药物治疗方案。虽然尚未出现一种改善药物依从性的干预措施优于其他措施,但短信药物提醒有可能帮助改善未控制高血压的非裔美国人的药物依从性,因为该人群的手机使用率很高。
这项两阶段研究的目的是开发(第一阶段)并在随机对照试验(RCT)中进行测试(第二阶段)一种短信系统BPMED,通过提高未控制高血压的非裔美国人的药物依从性来改善药物管理质量。
在第一阶段,我们从一家初级保健诊所招募了16名目标最终用户,通过参加三个焦点小组之一来协助开发BPMED。焦点小组旨在了解患者对高血压、药物依从性、手机使用以及使用短信支持药物依从性的看法。向参与者展示了潜在的干预设计,并征求他们对这些设计的反馈。在第二阶段,我们进行了两项试点随机对照试验,以确定BPMED在初级保健和急诊科环境中的可行性、可接受性和初步疗效。两项试点研究均招募了约60名参与者,他们被平均随机分配到常规护理组和BPMED干预组。
虽然数据收集现已完成,但两项试点随机对照试验的数据分析仍在进行中,预计2015年得出结果。
本研究旨在确定我们的方法在初级保健和急诊科环境中未控制高血压的非裔美国人中的初步可行性和可接受性。这些研究的结果非常令人关注,因为在记录使用短信药物提醒来改善高血压相关结局方面,尤其是在服务不足的城市少数群体中,所做的工作很少。
Clinicaltrials.gov NCT01465217;https://clinicaltrials.gov/ct2/show/NCT01465217(由WebCite存档于http://www.webcitation.org/6V0tto0lZ)。