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基于网络的自我管理策略支持与常规护理对初级保健中 COPD 患者的效果比较:一项随机、12 个月、平行组实用临床试验方案。

Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial.

机构信息

Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden

Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.

出版信息

BMJ Open. 2019 Oct 7;9(10):e030788. doi: 10.1136/bmjopen-2019-030788.

DOI:10.1136/bmjopen-2019-030788
PMID:31594889
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6797375/
Abstract

INTRODUCTION

The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a web-based solution, the COPD Web, in a cohort of people with COPD in a primary healthcare context.

METHODS AND ANALYSIS

The overall design is a pragmatic randomised controlled trial with preassessments and postassessments (3 and 12 months) and an implementation and user experience evaluation. People with a diagnosis of COPD, treated in primary healthcare will be eligible for the study. A total of 144 participants will be enrolled through advertisment or by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessment, randomised to either control or intervention group. All participants will receive usual care, a pedometer and a leaflet about the importance of PA. Participants in the intervention will, in addition, get access to the COPD Web, an interactive self-managed website that aims to support people with COPD in self-management strategies. They will also continuously get support from prompts with a focus on behaviour change.The effect on participants' PA, dyspnoea, COPD-related symptoms, HRQoL and health economics will be assessed using accelerometer and questionnaires. To identify enablers and barriers for the use of web-based support to change behaviour, semistructured interviews will be conducted in a subgroup of participants at the 3 months follow-up.

ETHICS AND DISSEMINATION

Ethical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274 and dnr 2019-05572. Findings will be presented at conferences, submitted for publication in peer-reviewed journals and presented to the involved healthcare professionals, participants and patient organisations.

TRIAL REGISTRATION NUMBER

NCT03746873.

摘要

简介

对于慢性阻塞性肺疾病(COPD)患者来说,使用足够的自我管理策略可能会增加身体活动(PA)水平,改善健康相关生活质量(HRQoL)并减少医疗保健的使用。在 COPD 患者中,除了提示(电子邮件和短信)之外,基于网络的支持是否可以用于促进自我管理策略以促进行为改变尚不清楚。这项临床试验旨在为 COPD 网络这一基于网络的解决方案在初级保健环境中的 COPD 患者队列中的效果提供证据。

方法和分析

总体设计是一项实用的随机对照试验,包括预评估和后评估(3 个月和 12 个月)以及实施和用户体验评估。在初级保健中接受治疗的 COPD 患者将有资格参加该研究。将通过广告或由参与的初级保健单位的医疗保健专业人员招募共 144 名参与者,在完成基线评估后,将他们随机分配到对照组或干预组。所有参与者都将接受常规护理、计步器和一份关于 PA 重要性的传单。干预组的参与者除了可以访问 COPD 网络外,还可以访问一个互动的自我管理网站,该网站旨在帮助 COPD 患者进行自我管理策略。他们还将持续获得重点关注行为改变的提示支持。将使用加速度计和问卷评估参与者 PA、呼吸困难、COPD 相关症状、HRQoL 和健康经济学的影响。为了确定使用基于网络的支持来改变行为的促进因素和障碍,将在 3 个月随访时对参与者进行半结构化访谈。

伦理和传播

瑞典于默奥地区伦理审查委员会已批准该研究,注册号为 2018-274 和 2019-05572。研究结果将在会议上公布,投稿发表于同行评审期刊,并提交给相关医疗保健专业人员、参与者和患者组织。

试验注册号

NCT03746873。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26f5/6797375/de350cb0a56f/bmjopen-2019-030788f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26f5/6797375/0d95bee8fcb3/bmjopen-2019-030788f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26f5/6797375/de350cb0a56f/bmjopen-2019-030788f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26f5/6797375/0d95bee8fcb3/bmjopen-2019-030788f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26f5/6797375/de350cb0a56f/bmjopen-2019-030788f02.jpg

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