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基于家庭的心脏康复:在巴基斯坦拉合尔的冠状动脉疾病患者中的开发、实施和结果评估 - 一项混合方法研究方案。

Home-based cardiac rehabilitation: development, implementation and outcome evaluation in patients with coronary artery diseases in Lahore, Pakistan - a mixed-methods study protocol.

机构信息

School of Nursing and Midwifery, The Aga Khan University, Karachi, Pakistan

Nursing Education, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan.

出版信息

BMJ Open. 2023 Jun 8;13(6):e073673. doi: 10.1136/bmjopen-2023-073673.

Abstract

INTRODUCTION

Cardiac rehabilitation (CR) is an important strategy to bring cardiac patients back to a normal life after a cardiac event. The benefits of CR as part of secondary prevention are widely known among people who have undergone myocardial infarction or revascularisation. As evidenced by several systematic reviews and meta-analyses, home-based CR (HBCR) has similar or greater effects on health-related quality of life, health outcomes, physical activity, anxiety and unplanned visits to the emergency department as compared with centre-based CR. The purpose of this study is to develop a contextual HBCR intervention and evaluate its effects on quality of life, health behaviours, bio-physiological parameters and emergency hospital visits of patients with coronary artery diseases in Lahore, Pakistan.

METHODS AND ANALYSIS

This study will employ a mixed-method exploratory sequential research design. The researchers will invite 15-20 cardiac patients and 12-15 healthcare providers for semi-structured interviews in the qualitative phase of the study. Once the intervention is developed and validated through the qualitative phase, the outcomes will be evaluated through a single-blinded randomised control trial in the quantitative phase. A total of 118 patients with acute coronary syndrome will be recruited through a screening checklist and randomly allocated into the control and intervention groups (59 patients in each group). The inductive coding approach will be used for the thematic analysis of qualitative data, whereas the quantitative data will be analysed through descriptive and inferential statistics using SPSS to see the difference within the groups, between groups and between three intervals.

ETHICS AND DISSEMINATION

The Ethical Review Committee of Aga Khan University and Mayo Hospital Lahore under the registration number 2023-8282-24191 and No/75749MH have approved this study protocol, respectively. The results of this study will be disseminated to participating patients (in the Urdu language), healthcare professionals and the public by publishing the manuscript in an open-access peer-reviewed journal and presenting it at different conferences.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clinical Trial Registry (ACTRN12623000049673p).

摘要

简介

心脏康复(CR)是使心脏病患者在心脏病发作后恢复正常生活的重要策略。CR 作为二级预防的一部分的益处,已被接受过心肌梗死或血运重建的人广泛了解。有几项系统评价和荟萃分析表明,与基于中心的 CR 相比,家庭为基础的 CR(HBCR)在健康相关生活质量、健康结果、身体活动、焦虑和计划外急诊就诊方面具有相似或更大的效果。本研究的目的是开发一种情境性 HBCR 干预措施,并评估其对巴基斯坦拉合尔冠状动脉疾病患者生活质量、健康行为、生物生理参数和急诊就诊的影响。

方法和分析

本研究将采用混合方法探索性序贯研究设计。研究人员将在研究的定性阶段邀请 15-20 名心脏病患者和 12-15 名医疗保健提供者进行半结构式访谈。一旦通过定性阶段开发和验证了干预措施,就将通过定量阶段的单盲随机对照试验来评估结果。通过筛选清单,将总共招募 118 名急性冠状动脉综合征患者,并将其随机分配到对照组和干预组(每组 59 名患者)。将使用归纳编码方法对定性数据进行主题分析,而定量数据将通过使用 SPSS 进行描述性和推断性统计分析,以观察组内、组间和三个时间间隔之间的差异。

伦理和传播

Aga Khan 大学和拉合尔 Mayo 医院的伦理审查委员会分别以注册号 2023-8282-24191 和 No/75749MH 批准了本研究方案。本研究的结果将以发表在开放获取同行评议期刊上的论文和在不同会议上的报告形式分发给参与患者(乌尔都语)、医疗保健专业人员和公众。

试验注册编号

澳大利亚新西兰临床试验注册中心(ACTRN12623000049673p)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3af9/10254856/aaec266829b7/bmjopen-2023-073673f01.jpg

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