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基于数字化平台和结构化电话支持的以患者为中心的护理对慢性阻塞性肺疾病和/或慢性心力衰竭患者的效果:PROTECT 随机对照试验方案。

Person-centred care by a combined digital platform and structured telephone support for people with chronic obstructive pulmonary disease and/or chronic heart failure: study protocol for the PROTECT randomised controlled trial.

机构信息

Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

Centre for Person-Centred Care, University of Gothenburg, Gothenburg, Sweden.

出版信息

BMJ Open. 2020 Jul 19;10(7):e036356. doi: 10.1136/bmjopen-2019-036356.

Abstract

BACKGROUND

A core feature of chronic obstructive pulmonary disorder (COPD) and chronic heart failure (CHF) is that symptoms may change rapidly because of illness progression. Thus, these chronic conditions are associated with high rehospitalisation rates. Person-centred care (PCC) has been shown to have several benefits for patients with COPD or CHF (or both disorders) but it has not yet been investigated through e-health services.

AIM

The project aims to evaluate the effects of PCC by a combined digital platform and structured telephone support for people with COPD and/or CHF.

METHODS AND ANALYSIS

A randomised controlled trial with open, parallel groups which employs a participatory design process will be used. This project will also include process and health economic evaluation of the intervention.

ETHICS AND DISSEMINATION

Ethical approval has been secured from the Regional Ethical Review Board in Gothenburg, Sweden (Dnr 063-17 and T063-18). Results will be presented at conferences and to healthcare professionals, participants and patient organisations. Findings will also be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT03183817.

摘要

背景

慢性阻塞性肺疾病(COPD)和慢性心力衰竭(CHF)的一个核心特征是,由于疾病进展,症状可能会迅速变化。因此,这些慢性疾病与高再入院率有关。以患者为中心的护理(PCC)已被证明对 COPD 或 CHF(或两种疾病都有)患者有多种益处,但尚未通过电子健康服务进行研究。

目的

该项目旨在通过联合数字平台和结构化电话支持,对 COPD 和/或 CHF 患者进行 PCC 的效果评估。

方法和分析

将使用随机对照试验,开放、平行组,采用参与式设计过程。该项目还将包括对干预措施的过程和健康经济评估。

伦理和传播

已从瑞典哥德堡地区伦理审查委员会获得伦理批准(Dnr 063-17 和 T063-18)。结果将在会议上以及向医疗保健专业人员、参与者和患者组织报告。研究结果也将提交给同行评议期刊发表。

试验注册号

NCT03183817。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b623/7371144/14795a260ad7/bmjopen-2019-036356f01.jpg

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