2型糖尿病患者自我管理的手机应用程序卡塔尔世界杯8强波胆分析多中心实用随机对照试验%A Agarwal,Payal %A Mukerji,Geetha %A Desveaux,Laura %A Ivers,Noah M %A Bhattacharyya,Onil %A Hensel,Jennifer M %A Shaw,James %A Bouck,Zachary %A Jamieson,Trevor %A Onabajo,Nike %A Cooper,Madeline %A Marani,Husayn %A Jeffs,Lianne %A Bhatia,R Sacha %+女子学院医院卫生系统解决方案和虚拟护理研究所,女子学院医院,多伦多,M5S 1B2,加拿大,14163236400,payal.agarwal@wchospital.ca %K移动应用程序%K糖尿病,2型%K自我管理%K血糖自我监测%K随机对照试验%K实用临床试验%D 2019 %7 10.01.2019 %9原文%J JMIR移动健康Uhealth %G英文%X由于2型糖尿病的日益流行给卫生系统带来了适当管理这些患者的压力,因此设计用于改善糖尿病自我管理的移动应用程序越来越多。其中一款名为蓝星(BlueStar)的应用程序在小型研究中被证明可以显著降低血红蛋白A1c (HbA1c)水平,是美国第一个获得食品和药物管理局(Food and Drug Administration)批准的移动处方疗法应用程序。然而,该应用程序在不同临床站点和卫生系统中对现实世界人口的影响尚不清楚。目的:本研究的主要目的是对蓝星移动应用程序进行一项实用的随机对照试验,以确定应用程序的使用是否会改善现实临床环境中不同参与者的HbA1c水平。我们假设与对照组相比,这个移动应用程序可以改善自我管理和HbA1c水平。方法:采用多中心实用随机对照试验。总体而言,随机分配到立即治疗组(ITG)的110名参与者接受了为期6个月的干预,随机分配到等候名单对照组(WLC)的113名参与者接受了前3个月的常规护理,然后接受了3个月的干预。 The primary outcome was glucose control measured by HbA1c levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app. Results: The results of an analysis of covariance controlling for baseline HbA1c levels did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG−WLC] −0.42, 95% CI −1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants’ 3-month HbA1c levels (95% CI −0.03 to −0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51). Conclusions: The results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA1c levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed. Trial Registration: Clinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343) %M 30632972 %R 10.2196/10321 %U https://mhealth.www.mybigtv.com/2019/1/e10321/ %U https://doi.org/10.2196/10321 %U http://www.ncbi.nlm.nih.gov/pubmed/30632972
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