The Everyday Function Intervention Trial (EFIT) protocol: A randomized clinical trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-01-30 DOI:10.1016/j.cct.2025.107829

Lesley A. Ross , Courtney Fine , Abigail T. Stephan , Hye Won Chai , Ava McVey , Christine B. Phillips , Alyssa Gamaldo , Jacqueline Mogle , Nancy Dennis , Martin Sliwinski , Kristina Visscher

{"title":"The Everyday Function Intervention Trial (EFIT) protocol: A randomized clinical trial","authors":"Lesley A. Ross , Courtney Fine , Abigail T. Stephan , Hye Won Chai , Ava McVey , Christine B. Phillips , Alyssa Gamaldo , Jacqueline Mogle , Nancy Dennis , Martin Sliwinski , Kristina Visscher","doi":"10.1016/j.cct.2025.107829","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Preserving cognition and everyday function is essential for maintaining independence and reducing risk of Alzheimer's disease and related dementias (ADRD). Useful Field of View training (UFOV<em>t</em>) is a computerized cognitive training program that achieves these goals; however, the mechanisms underlying UFOV<em>t</em> are unclear. The Everyday Function Intervention Trial (EFIT) is a double-blind randomized clinical controlled trial designed to assess potential cognitive, psychosocial, biological, and lifestyle mechanisms underlying UFOV<em>t</em>. In the current paper, we outline the protocol employed in EFIT.</div></div><div><h3>Methods</h3><div>Community-dwelling older adults (<em>N</em> = 96) completed cognitive, psychosocial, health, and lifestyle assessments on a study-provided laptop at baseline, post-test, and three-month follow-up, along with additional daily cognitive, psychosocial, health, and lifestyle assessments on a study-provided smartphone throughout the study period. Following baseline, participants were randomized into the cognitive training or active control group completing twenty hours of brain games across ten weeks. A subsample (<em>n</em> = 38) completed additional activities: wearing a FitBit, undergoing MRI scans, and using at-home sleep monitors across two nights at baseline and post-test. Aside from MRI sessions, participants completed study activities remotely.</div></div><div><h3>Discussion</h3><div>EFIT's design included several novel features: ecological momentary assessment; remote data collection; evaluation of mediators before, during, and after training; training tasks targeting one cognitive domain at a time; performance-based <em>and</em> self-reported everyday function and instrumental activities of daily living measures; use of an active control group; and an exploratory multilevel modeling analytic approach. These features will provide an in-depth understanding of intervention transfer effects and guide the design of future cognitive interventions.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107829"},"PeriodicalIF":2.0000,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425000230","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Preserving cognition and everyday function is essential for maintaining independence and reducing risk of Alzheimer's disease and related dementias (ADRD). Useful Field of View training (UFOVt) is a computerized cognitive training program that achieves these goals; however, the mechanisms underlying UFOVt are unclear. The Everyday Function Intervention Trial (EFIT) is a double-blind randomized clinical controlled trial designed to assess potential cognitive, psychosocial, biological, and lifestyle mechanisms underlying UFOVt. In the current paper, we outline the protocol employed in EFIT.

Methods

Community-dwelling older adults (N = 96) completed cognitive, psychosocial, health, and lifestyle assessments on a study-provided laptop at baseline, post-test, and three-month follow-up, along with additional daily cognitive, psychosocial, health, and lifestyle assessments on a study-provided smartphone throughout the study period. Following baseline, participants were randomized into the cognitive training or active control group completing twenty hours of brain games across ten weeks. A subsample (n = 38) completed additional activities: wearing a FitBit, undergoing MRI scans, and using at-home sleep monitors across two nights at baseline and post-test. Aside from MRI sessions, participants completed study activities remotely.

Discussion

EFIT's design included several novel features: ecological momentary assessment; remote data collection; evaluation of mediators before, during, and after training; training tasks targeting one cognitive domain at a time; performance-based and self-reported everyday function and instrumental activities of daily living measures; use of an active control group; and an exploratory multilevel modeling analytic approach. These features will provide an in-depth understanding of intervention transfer effects and guide the design of future cognitive interventions.

查看原文本刊更多论文

日常功能干预试验（EFIT）方案：随机临床试验。

背景：保持认知和日常功能对于维持独立性和降低阿尔茨海默病和相关痴呆（ADRD）的风险至关重要。有用视场训练（UFOVt）是一种实现这些目标的计算机化认知训练程序；然而，不明飞行物的潜在机制尚不清楚。日常功能干预试验（EFIT）是一项双盲随机临床对照试验，旨在评估不明飞行物潜在的认知、社会心理、生物学和生活方式机制。在本文中，我们概述了EFIT中使用的协议。方法：居住在社区的老年人（N = 96）在基线、测试后和三个月的随访中使用研究提供的笔记本电脑完成认知、社会心理、健康和生活方式评估，同时在整个研究期间使用研究提供的智能手机完成额外的日常认知、社会心理、健康和生活方式评估。在基线之后，参与者被随机分为认知训练组和积极对照组，在10周内完成20小时的脑力游戏。一个子样本（n = 38）完成了额外的活动：佩戴FitBit，接受核磁共振扫描，并在基线和测试后的两个晚上使用家庭睡眠监视器。除了核磁共振成像，参与者还远程完成了研究活动。讨论：EFIT的设计包括几个新颖的特点：生态瞬时评估；远程数据采集；在培训之前、期间和之后对调解员进行评估；一次针对一个认知领域的训练任务；基于表现和自我报告的日常功能和日常生活测量的工具性活动；使用积极对照组；并提出了一种探索性的多层次建模分析方法。这些特征将提供对干预转移效应的深入理解，并指导未来认知干预的设计。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.