Morawski Kyle, Ghazinouri Roya, Krumme Alexis, McDonough Julianne, Durfee Erin, Oley Leslie, Mohta Namita, Juusola Jessie, Choudhry Niteesh K
Center for Healthcare Delivery Sciences (C4HDS) and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Evidation Health, Menlo Park, CA.
Am Heart J. 2017 Apr;186:40-47. doi: 10.1016/j.ahj.2016.11.007. Epub 2016 Dec 9.
Hypertension is a major contributor to the health and economic burden imposed by stroke, heart disease, and renal insufficiency. Antihypertensives can prevent many of the harmful effects of elevated blood pressure, but medication nonadherence is a known barrier to the effectiveness of these treatments. Smartphone-based applications that remind patients to take their medications, provide education, and allow for social interactions between individuals with similar health concerns have been widely advocated as a strategy to improve adherence but have not been subject to rigorous testing.
METHODS/DESIGN: The MedISAFE-BP study is a prospective, randomized control trial designed to evaluate the impact on blood pressure and medication adherence of an mhealth application (Medisafe). Four hundred thirteen patients with uncontrolled hypertension have been enrolled and randomized in a 1:1 fashion to usual care or to the use of the Medisafe mhealth platform. Patients will be followed up for 12 weeks and the trial's co-primary outcomes will be change in systolic blood pressure and self-reported medication adherence.
The MedISAFE-BP trial is the first study to rigorously evaluate an mhealth application's effect on blood pressure and medication adherence. The results will inform the potential effectiveness of this simple system in improving cardiovascular disease risk factors and clinical outcomes.
高血压是导致中风、心脏病和肾功能不全所带来的健康和经济负担的主要因素。抗高血压药物可以预防血压升高带来的许多有害影响，但药物治疗依从性不佳是这些治疗效果的一个已知障碍。基于智能手机的应用程序可以提醒患者服药、提供教育，并允许有相似健康问题的个体之间进行社交互动，作为一种提高依从性的策略已得到广泛提倡，但尚未经过严格测试。
方法/设计：MedISAFE-BP研究是一项前瞻性随机对照试验，旨在评估一款移动健康应用程序（Medisafe）对血压和药物治疗依从性的影响。413例高血压控制不佳的患者已入组，并以1:1的方式随机分为常规治疗组或使用Medisafe移动健康平台组。患者将接受12周的随访，试验的共同主要结局将是收缩压的变化和自我报告的药物治疗依从性。
MedISAFE-BP试验是第一项严格评估移动健康应用程序对血压和药物治疗依从性影响的研究。研究结果将为这个简单系统在改善心血管疾病危险因素和临床结局方面的潜在有效性提供依据。
