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一项使用基于智能手机应用程序的药物依从性和二级预防中风危险因素管理(MaMoRS)的随机对照试验。

A randomized controlled trial of medication adherence and management of risk factors for secondary prevention of stroke (MaMoRS) using a smartphone-based application.

机构信息

Neurology Department, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum, India.

Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum, India.

出版信息

Int J Stroke. 2024 Jul;19(6):654-664. doi: 10.1177/17474930241245612. Epub 2024 Apr 22.

DOI:10.1177/17474930241245612
PMID:38533606
Abstract

BACKGROUND

There are little data on the use of smartphone-based applications for medication adherence and risk-factor control for the secondary prevention of stroke in low-and-middle-income countries (LMICs).

AIMS

The aim was to determine whether a smartphone-based app improved medication adherence, risk-factor control, and provided health education to stroke survivors for lifestyle and behavioral modifications.

METHODS

An unblinded, single-center randomized controlled double arm trial with 1:1 allocation among stroke survivors was performed in South India. The primary outcome was medication adherence, with co-primary outcomes of lifestyle and behavioral factors and control of vascular risk factors, at 3 and 6 months.

RESULTS

Among 351 stroke survivors screened, 209 were recruited. The mean (standard deviation (SD)) age of the intervention (n = 105) group was 60 (12) years and that of the control (n = 104) group was 60 (10) years. In the primary outcome, mean medication adherence significantly improved in the intervention group with a between group difference of 0.735 (95% confidence interval (CI) = 0.419 to 1.050), p < 0.001. Being in intervention group (OR = 4.5; 95% CI = 2.3 to 8.9), stroke recurrence (OR = 3.3 (95% CI = 1.9 to 7.8)), and regular physician visits (OR = 2.1; 95% CI = 1.0 to 4.4) were significant predictors of good medication adherence. Considering the co-primary outcomes, compared to the control group, participants in the intervention group had a greater improvement in self-reported healthy diet intake (p = 0.003), intake of fruits (p = 0.005), and were physically more active (p = 0.001). At 6 months, mean fasting blood sugar (p = 0.005) and high-density lipoprotein cholesterol higher (p = 0.024) in the intervention group.

CONCLUSIONS

The use of a mobile app is an effective method to improve medication adherence and risk-factor control in stroke survivors and is feasible in LMICs like India.

DATA ACCESS STATEMENT

Data used during the study are available from the corresponding author on request.

TRIAL REGISTRATION

The study is registered in Clinical Trial Registry of India (CTRI/2022/06/042980).

摘要

背景

关于智能手机应用程序在中低收入国家(LMICs)中用于药物依从性和二级预防中风的风险因素控制,数据很少。

目的

目的是确定智能手机应用程序是否可以提高中风幸存者的药物依从性,控制风险因素,并提供健康教育,以促进生活方式和行为改变。

方法

在印度南部进行了一项未设盲、单中心、随机对照双臂试验,中风幸存者以 1:1 比例分配。主要结局是药物依从性,次要结局包括生活方式和行为因素以及血管风险因素的控制,分别在 3 个月和 6 个月时进行评估。

结果

在筛选出的 351 名中风幸存者中,有 209 名被招募。干预组(n=105)的平均(标准差(SD))年龄为 60(12)岁,对照组(n=104)的年龄为 60(10)岁。在主要结局方面,干预组的药物依从性显著改善,组间差异为 0.735(95%置信区间(CI)=0.419 至 1.050),p<0.001。处于干预组(OR=4.5;95%CI=2.3 至 8.9)、中风复发(OR=3.3(95%CI=1.9 至 7.8))和定期看医生(OR=2.1;95%CI=1.0 至 4.4)是药物依从性良好的显著预测因素。考虑到次要结局,与对照组相比,干预组参与者在自我报告的健康饮食摄入(p=0.003)、水果摄入(p=0.005)和身体活动(p=0.001)方面有更大的改善。在 6 个月时,干预组的空腹血糖(p=0.005)和高密度脂蛋白胆固醇(p=0.024)更高。

结论

使用移动应用程序是提高中风幸存者药物依从性和风险因素控制的有效方法,在印度等 LMICs 是可行的。

数据访问声明

研究期间使用的数据可应要求向通讯作者索取。

试验注册

该研究在印度临床试验注册中心(CTRI/2022/06/042980)注册。

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