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加纳 10 家医院开展的基于电话的护士指导下卒中干预(PINGS-II)实施结果的混合方法研究方案。

Protocol for a mixed-methods study to explore implementation outcomes of the Phone-based Interventions under Nurse Guidance after Stroke (PINGS-II) across 10 hospitals in Ghana.

机构信息

Department of Global Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

Department of Implementation Research, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.

出版信息

BMJ Open. 2024 Aug 28;14(8):e084584. doi: 10.1136/bmjopen-2024-084584.

DOI:10.1136/bmjopen-2024-084584
PMID:39209507
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11367291/
Abstract

BACKGROUND

Stroke survivors are at a substantially higher risk for adverse vascular events driven partly by poorly controlled vascular risk factors. Mobile health interventions supported by task shifting strategies have been feasible to test in small pilot trials in low-income settings to promote vascular risk reduction after stroke. However, real-world success and timely implementation of such interventions remain challenging, necessitating research to bridge the know-do gap and expedite improvements in stroke management. The Phone-based Interventions under Nurse Guidance after Stroke (PINGS-II) is a nurse-led mHealth intervention for blood pressure control among stroke survivors, currently being assessed for efficacy in a hybrid clinical trial across 10 hospitals in Ghana compared with usual care. This protocol aims to assess implementation outcomes such as feasibility, appropriateness, acceptability, fidelity, cost and implementation facilitators and barriers of the PINGS-II intervention.

METHODS AND ANALYSIS

This study uses descriptive mixed methods. Qualitative data to be collected include in-depth interviews and FGDs with patients who had a stroke on the PINGS-II intervention, as well as key informant interviews with medical doctors and health policy actors (implementation context, barriers and facilitators). Data will be analysed by thematic analysis. Quantitative data sources include structured questionnaires for clinicians (feasibility, acceptability and appropriateness), and patients who had a stroke (fidelity and costs). Analysis will include summary statistics like means, medians, proportions and exploratory tests of association including χ analysis.

ETHICS AND DISSEMINATION

Ethics approval was obtained from the Committee for Human Research Publication and Ethics at the Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. Voluntary written informed consent will be obtained from all participants. All the rights of the participants and ethical principles guiding scientific research shall be adhered to. Findings from the study will be presented in scientific conferences and published in a peer-reviewed scientific journal. A dissemination meeting will be held with relevant agencies of the Ghana Ministry of Health, clinicians, patient group representatives, and non-governmental organisations.

摘要

背景

中风幸存者发生不良血管事件的风险大大增加,部分原因是血管风险因素控制不佳。在低收入环境中,通过任务转移策略支持的移动健康干预措施已经在小型试点试验中进行了可行性测试,以促进中风后降低血管风险。然而,此类干预措施在实际中的成功和及时实施仍然具有挑战性,需要研究来弥合知识与实践之间的差距,并加快中风管理的改善。基于电话的护士指导下中风后干预措施(PINGS-II)是一种针对中风幸存者血压控制的护士主导的移动健康干预措施,目前正在加纳的 10 家医院进行一项混合临床试验,以评估其与常规护理相比的疗效。本方案旨在评估 PINGS-II 干预措施的实施结果,如可行性、适当性、可接受性、保真度、成本和实施促进因素和障碍。

方法和分析

本研究采用描述性混合方法。将收集的定性数据包括对接受 PINGS-II 干预的中风患者进行深入访谈和焦点小组讨论,以及对医生和卫生政策制定者进行关键人物访谈(实施背景、障碍和促进因素)。数据将通过主题分析进行分析。定量数据来源包括临床医生的结构化问卷(可行性、可接受性和适当性)和中风患者的问卷(保真度和成本)。分析将包括汇总统计数据,如均值、中位数、比例和包括卡方分析在内的关联探索性检验。

伦理和传播

该研究已获得加纳库马西夸梅·恩克鲁玛科技大学人类研究出版和伦理委员会的伦理批准。将从所有参与者那里获得自愿的书面知情同意。所有参与者的权利和指导科学研究的伦理原则都将得到遵守。研究结果将在科学会议上展示,并发表在同行评议的科学期刊上。将与加纳卫生部相关机构、临床医生、患者团体代表和非政府组织举行一次传播会议。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1840/11367291/75649a1874f4/bmjopen-14-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1840/11367291/75649a1874f4/bmjopen-14-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1840/11367291/75649a1874f4/bmjopen-14-8-g001.jpg

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本文引用的文献

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Efficacy of an mHealth App to Support Patients' Self-Management of Hypertension: Randomized Controlled Trial.移动医疗应用支持高血压患者自我管理的疗效:随机对照试验。
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Feasibility, acceptability, and appropriateness of a mobile health stroke intervention among Ghanaian health workers.加纳卫生工作者中移动医疗卒中干预的可行性、可接受性和适宜性。
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Effects of Telemedicine and mHealth on Systolic Blood Pressure Management in Stroke Patients: Systematic Review and Meta-Analysis of Randomized Controlled Trials.远程医疗和移动医疗对脑卒中患者收缩压管理的影响:随机对照试验的系统评价和荟萃分析。
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Phone-Based Intervention under Nurse Guidance after Stroke (PINGS II) Study: Protocol for a Phase III Randomized Clinical Trial.基于护士指导的中风后电话干预(PINGS II)研究:一项 III 期随机临床试验方案。
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