调查在线强化护理计划对急性失代偿性心力衰竭出院患者情绪和身体健康的影响：一项随机对照试验的研究方案：心力衰竭强化护理计划

Investigating the effect of an online enhanced care program on the emotional and physical wellbeing of patients discharged from hospital with acute decompensated heart failure: Study protocol for a randomised controlled trial: Enhanced care program for heart failure.

作者信息

Fakes Kristy, Hobden Breanne, Zwar Nick, Collins Nick, Oldmeadow Christopher, Paolucci Francesco, Davies Allan, Fernando Irosh, McGee Michael, Williams Trent, Robson Cameron, Hungerford Robert, Ooi Jia Ying, Sverdlov Aaron L, Sanson-Fisher Rob, Boyle Andrew J

机构信息

Health Behaviour Research Collaborative, School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia.

Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.

出版信息

Digit Health. 2024 May 28;10:20552076241256503. doi: 10.1177/20552076241256503. eCollection 2024 Jan-Dec.

DOI:10.1177/20552076241256503

PMID:38817841

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11138184/

Abstract

OBJECTIVE

Depression is highly prevalent and associated with increased hospitalisations and mortality among patients with heart failure (HF). This study will evaluate the effectiveness and cost-effectiveness of an online wellbeing program for patients discharged from hospital with acute decompensated heart failure (ADHF) in (i) improving emotional and physical wellbeing, and (ii) decreasing healthcare utilisation.

METHODS

Two-arm randomised controlled trial. Eligible patients with ADHF will be recruited pre-discharge from two hospitals. Five hundred and seventy participants will be randomised to receive the intervention (online enhanced care program for HF: 'Enhanced HF Care') or usual care. Enhanced HF Care includes health education (11 micro-learning modules) and monitoring of depression and clinical outcomes via fortnightly/monthly surveys for 6 months, with participants offered tailored advice via video email and SMS. Cardiac nurses track real-time patient data from a dashboard and receive automated email alerts when patients report medium- or high-risk levels of depression or clinical symptoms, to action where needed. General practitioners also receive automated alerts if patients report medium- or high-risk survey responses and are encouraged to schedule a patient consultation.

RESULTS

Sixty-five participants enrolled to-date. Co-primary outcomes ('Minnesota Living with Heart Failure Questionnaire' Emotional and Physical subscales) and healthcare utilisation (secondary outcome) at 1- and 6-month post-recruitment will be compared between treatment arms using linear mixed effects regression models.

CONCLUSIONS

This study has the potential to reduce the burden of depression for patients with HF by prioritising urgent mental health needs and clinical symptoms while simultaneously empowering patients with self-care knowledge.

TRIAL REGISTRATION

The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12622001289707. Issue date: 4 October 2022.

摘要

目的

抑郁症在心力衰竭（HF）患者中极为普遍，且与住院率和死亡率增加相关。本研究将评估一项针对急性失代偿性心力衰竭（ADHF）出院患者的在线健康计划在以下方面的有效性和成本效益：（i）改善情绪和身体健康，以及（ii）降低医疗保健利用率。

方法

双臂随机对照试验。符合条件的ADHF患者将在两家医院出院前招募。570名参与者将被随机分配接受干预（针对HF的在线强化护理计划：“强化HF护理”）或常规护理。强化HF护理包括健康教育（11个微学习模块），并通过每两周/每月一次的调查对抑郁症和临床结果进行6个月的监测，通过视频电子邮件和短信为参与者提供量身定制的建议。心脏科护士从仪表板跟踪实时患者数据，当患者报告中度或高风险的抑郁或临床症状水平时接收自动电子邮件警报，以便在需要时采取行动。如果患者报告中度或高风险的调查回复，全科医生也会收到自动警报，并被鼓励安排患者会诊。