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ManageHF4Life 移动应用对慢性心力衰竭患者的影响:随机对照试验。

The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial.

机构信息

Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI, United States.

Frankel Cardiovascular Center, University of Michigan, Ann Arbor, MI, United States.

出版信息

JMIR Mhealth Uhealth. 2021 Dec 7;9(12):e26185. doi: 10.2196/26185.

DOI:10.2196/26185
PMID:34878990
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8693200/
Abstract

BACKGROUND

The successful management of heart failure (HF) involves guideline-based medical therapy as well as self-management behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management.

OBJECTIVE

The aim of this paper was to evaluate the efficacy of enhanced self-management via a mobile app intervention on health-related quality of life, self-management, and HF readmissions.

METHODS

A single-center randomized controlled trial was performed. Participants older than 45 years and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group ("app group") used a mobile app, and the intervention prompted daily self-monitoring and promoted self-management. The control group ("no-app group") received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire score and recurrent HF admissions.

RESULTS

A total of 83 participants were enrolled and completed all baseline assessments. Baseline characteristics were similar between the groups except for the prevalence of ischemic HF. The app group had a reduced MLHFQ at 6 weeks (mean 37.5, SD 3.5 vs mean 48.2, SD 3.7; P=.04) but not at 12 weeks (mean 44.2, SD 4 vs mean 45.9, SD 4; P=.78), compared to the no-app group. There was no effect of the app on the SCHFI at 6 or 12 weeks. The time to first HF readmission was not statistically different between the app group and the no-app group (app group 11/42, 26% vs no-app group 12/41, 29%; hazard ratio 0.89, 95% CI 0.39-2.02; P=.78) over 12 weeks.

CONCLUSIONS

The adaptive mobile app intervention, which focused on promoting self-monitoring and self-management, improved the MLHFQ at 6 weeks but did not sustain its effects at 12 weeks. No effect was seen on HF self-management measured by self-report. Further research is needed to enhance engagement in the app for a longer period and to determine if the app can reduce HF readmissions in a larger study.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03149510; https://clinicaltrials.gov/ct2/show/NCT03149510.

摘要

背景

心力衰竭(HF)的成功管理涉及基于指南的医学治疗和自我管理行为。因此,HF 的管理正朝着协助患者进行监测和自我管理的主动实时技术模型发展。

目的

本文旨在评估通过移动应用程序干预增强自我管理对健康相关生活质量、自我管理和 HF 再入院的疗效。

方法

进行了一项单中心随机对照试验。纳入年龄大于 45 岁且因急性失代偿性 HF 入院或在过去 4 周内新近出院的患者。干预组(“应用程序组”)使用移动应用程序,该应用程序提示每日自我监测并促进自我管理。对照组(“无应用程序组”)接受常规护理。主要结局是从基线到 6 周和 12 周时明尼苏达州心力衰竭生活质量问卷(MLHFQ)评分的变化。次要结局是自我护理心力衰竭指数(SCHFI)问卷评分和 HF 再入院率。

结果

共纳入 83 名参与者并完成了所有基线评估。除缺血性 HF 的患病率外,两组的基线特征相似。与无应用程序组相比,应用程序组在 6 周时 MLHFQ 评分降低(均值 37.5,标准差 3.5 比均值 48.2,标准差 3.7;P=.04),但在 12 周时没有降低(均值 44.2,标准差 4 比均值 45.9,标准差 4;P=.78)。应用程序对 6 周和 12 周时的 SCHFI 没有影响。应用程序组和无应用程序组之间首次 HF 再入院的时间无统计学差异(应用程序组 11/42,26%比无应用程序组 12/41,29%;风险比 0.89,95%CI 0.39-2.02;P=.78),随访 12 周。

结论

专注于促进自我监测和自我管理的自适应移动应用程序干预在 6 周时改善了 MLHFQ,但在 12 周时没有维持其效果。自我报告测量的 HF 自我管理没有效果。需要进一步研究以增强对应用程序的更长时间参与,并确定该应用程序是否可以在更大的研究中降低 HF 再入院率。

试验注册

ClinicalTrials.gov NCT03149510;https://clinicaltrials.gov/ct2/show/NCT03149510。

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