Objectives This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD).

Background Newly developed smartphone-connected mHealth devices represent promising methods to diagnose common diseases in resource-limited areas; however, the impact of technology-based care on long-term outcomes has not been rigorously evaluated.

Methods A total of 253 patients with SHD were randomized to an initial diagnostic assessment with wireless devices in mHealth clinics (n = 139) or to standard-care (n = 114) in India. mHealth clinics were equipped with point-of-care devices including pocket-echocardiography, smartphone-connected-electrocardiogram blood pressure and oxygen measurements, activity monitoring, and portable brain natriuretic peptide laboratory testing. All individuals underwent comprehensive transthoracic echocardiography to assess the severity of SHD. The primary endpoint was the time to referral for therapy with percutaneous valvuloplasty or surgical valve replacement. Secondary endpoints included the probability of a cardiovascular hospitalization and/or death over 1 year.

Results An initial mHealth assessment was associated with a shorter time to referral for valvuloplasty and/or valve replacement (83 ± 79 days vs. 180 ± 101 days; p <0.001) and was associated with an increased probability for valvuloplasty/valve replacement compared to standard-care (34% vs. 32%; adjusted hazard ratio: 1.54; 95% CI: 0.96 to 2.47; p = 0.07). Patients randomized to mHealth were associated with a lower risk of a hospitalization and/or death on follow-up (15% vs. 28%, adjusted hazard ratio: 0.41; 95% CI: 0.21 to 0.83; p = 0.013).

Conclusions An initial mHealth diagnostic strategy was associated with a shorter time to definitive therapy among patients with SHD in a resource-limited area and was associated with improved outcomes. (A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics; NCT02881398)

目的本研究旨在确定在医疗现场用作临床决策支持工具的移动健康（mHealth）设备评估是否可以减少风湿性和结构性心脏病（SHD）患者的治疗时间并改善长期结果。

背景技术新开发的连接智能手机的mHealth设备代表了在资源有限的地区诊断常见疾病的有前途的方法。但是，尚未严格评估基于技术的护理对长期结果的影响。

方法在印度，共有253名SHD患者被随机分配到mHealth诊所（n = 139）或通过标准护理（n = 114）通过无线设备进行初步诊断评估。mHealth诊所配备了即时医疗设备，包括袖珍超声心动图，智能手机连接的心电图血压和氧气测量，活动监测以及便携式脑钠肽实验室测试。所有个体均接受全面的经胸超声心动图检查以评估SHD的严重程度。主要终点是经皮瓣膜成形术或外科瓣膜置换术转诊的时间。次要终点包括超过1年的心血管疾病住院和/或死亡的可能性。

结果最初的mHealth评估与瓣膜成形术和/或瓣膜置换术的转诊时间较短（83±79天vs. 180±101天； p <0.001），并且瓣膜成形术/瓣膜置换术的可能性比标准护理（34％比32％；调整后的危险比：1.54； 95％CI：0.96至2.47； p = 0.07）。随机分配到mHealth的患者随访时住院和/或死亡的风险较低（15％比28％，调整后的危险比：0.41； 95％CI：0.21至0.83； p = 0.013）。

结论最初的mHealth诊断策略与在资源有限地区的SHD患者进行明确治疗的时间较短有关，并且与改善结局有关。（在现代结构性心脏病诊所中进行的袖珍心动图综合移动健康设备评估的随机试验； NCT02881398）