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电子健康自我管理工具对患有多种慢性病的老年人的有效性(KeepWell):一项混合有效性-实施随机对照试验的方案。

Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial.

机构信息

Research and Innovation, North York General Hospital, Toronto, Ontario, Canada

Research and Innovation, University of Toronto, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2021 Feb 17;11(2):e048350. doi: 10.1136/bmjopen-2020-048350.

Abstract

INTRODUCTION

In response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called 'KeepWell' that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.

METHODS AND ANALYSIS

We will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness-implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.

ETHICS AND DISSEMINATION

Ethics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.

TRIAL REGISTRATION NUMBER

NCT04437238.

摘要

简介

为了应对老年人慢性病的负担,已经创建了不同的慢性病自我管理工具,以优化疾病管理。然而,这些工具很少考虑疾病管理的所有方面,通常不是专门为老年人开发的,也不是为持续使用而创建的,主要侧重于单一疾病。我们创建了一个名为“KeepWell”的电子健康自我管理应用程序,用于支持在家中需要复杂护理的老年人。它整合了两种或多种最常见的高负担慢性病中的护理。

方法和分析

我们将在一项为期 6 个月的实用、混合有效性实施随机对照试验中评估 KeepWell 的有效性、成本和采用率。年龄≥65 岁、有 1 种或多种慢性病、能理解并同意、能使用计算机或平板电脑设备、能上网并能使用电子邮件的英语使用者将有资格参加。所有同意参加的参与者将被随机分配到 KeepWell 组或对照组。分配序列将使用随机数生成器确定。主要结果是 6 个月时的感知自我效能。次要结果包括生活质量、健康背景/状况、生活方式(营养、身体活动、咖啡因、酒精、吸烟和膀胱健康)、社会参与和联系、电子健康素养;所有这些都通过嵌入 KeepWell(干预)或调查平台(对照组)的健康风险问卷收集。实施结果将包括可达性、有效性、采用率、忠实度、实施成本和可持续性。

伦理和传播

已获得北约克综合医院研究和伦理委员会的伦理批准。该研究由加拿大卫生研究院和安大略省卫生部资助。我们将与我们的团队合作制定传播策略,包括出版物、演讲、通俗易懂的摘要和结束资助会议。

试验注册号

NCT04437238。

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