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促进健康型脑健康的数字解决方案:一项用于临床实施的试点序贯多重分配随机试验(SMART)方案

Digital solution for salutogenic brain health: a pilot sequential multiple assignment randomised trial (SMART) protocol for clinical implementation.

作者信息

Chang Claire See Ying, Phua Vanessa, Tham Xiang Cong, Jia Yuanxi, Chen Nicole Yun Ching, Zhou Wentao, Liau Wei Fong, Xu Jing, Chakraborty Bibhas, Graves Nicholas, Sevdalis Nick, Dong Yanhong

机构信息

Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

National Healthcare Group Polyclinics, Singapore.

出版信息

BMJ Open. 2025 Mar 25;15(3):e096568. doi: 10.1136/bmjopen-2024-096568.

DOI:10.1136/bmjopen-2024-096568
PMID:40132849
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11938236/
Abstract

INTRODUCTION

Middle-aged adults with chronic conditions including diabetes, hyperlipidaemia and hypertension are at higher risk for cognitive decline. However, there is a lack of a targeted solution for this population. This study aims to develop a digital solution for salutogenic brain health targeting this population, assess its clinical effectiveness and evaluate the implementation in primary care settings by local champions, that is, nurses.

METHODS AND ANALYSIS

A type-I hybrid effectiveness-implementation design with a sequential multiple-assignment randomised trial will be adopted. 160 adults aged 40-64 years old with chronic conditions hypertension, hyperlipidaemia and type-II diabetes will be recruited from three National University Polyclinics in Singapore. They will be randomised using block randomisation to either the intervention group ('Digital solution for Salutogenic Brain health' programme) or the waitlist control group. Cognitive tests, clinical measures, questionnaires and interviews will be used to evaluate outcome measures. The Reach, Effectiveness, Adoption, Implementation, Maintenance framework and the Capability, Opportunity, Motivation and Behaviour model will be employed to evaluate clinical effectiveness and implementation strategies.

ETHICS AND DISSEMINATION

This study has been reviewed and approved by the National Healthcare Group Domain Specific Review Board (NHG DSRB) in Singapore (NHG DSRB Reference Number: 2023/00620 (25 June 2024)). Data will be analysed by study team members and findings will be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT06582316.

摘要

引言

患有糖尿病、高脂血症和高血压等慢性病的中年成年人认知能力下降的风险更高。然而,针对这一人群缺乏有针对性的解决方案。本研究旨在开发一种针对这一人群的促进健康脑健康的数字解决方案,评估其临床效果,并评估由当地倡导者即护士在基层医疗环境中的实施情况。

方法与分析

将采用一种I型混合有效性-实施设计,并进行序贯多重分配随机试验。将从新加坡的三家国立大学综合诊所招募160名年龄在40-64岁之间患有高血压、高脂血症和II型糖尿病等慢性病的成年人。他们将通过区组随机化被随机分配到干预组(“促进健康脑健康数字解决方案”项目)或等待名单对照组。将使用认知测试、临床测量、问卷调查和访谈来评估结果指标。将采用覆盖范围、有效性、采用率、实施情况、维持框架以及能力、机会、动机和行为模型来评估临床效果和实施策略。

伦理与传播

本研究已由新加坡国家医疗集团特定领域审查委员会(NHG DSRB)审查并批准(NHG DSRB参考编号:2023/00620(2024年6月25日))。数据将由研究团队成员进行分析,研究结果将发表在同行评审期刊上。

试验注册号

NCT06582316。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3e7/11938236/9238386388f1/bmjopen-15-3-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3e7/11938236/605e798b7ebb/bmjopen-15-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3e7/11938236/3ccecc35d071/bmjopen-15-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3e7/11938236/9238386388f1/bmjopen-15-3-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3e7/11938236/605e798b7ebb/bmjopen-15-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3e7/11938236/3ccecc35d071/bmjopen-15-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3e7/11938236/9238386388f1/bmjopen-15-3-g003.jpg

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