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A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study 蓝光与红光改善中风后睡眠、疲劳和认知的平行组随机对照试验:试验结果和进一步研究的建议。
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-06 DOI: 10.1016/j.cct.2024.107736
Douglas L. Weeks , Elena Crooks , Katie E. O'Brien , Gina Sprint , Gregory T. Carter , Kimberly A. Honn

Background

Disordered sleep and fatigue are common in the acute phase of stroke and can impede recovery.

Objective

A randomized parallel group placebo-controlled pilot study compared daily morning exposure to blue light or red light (placebo) for improving daytime sleepiness, fatigue, nocturnal sleep, and cognition in patients receiving inpatient rehabilitation for acute stroke.

Methods

43 patients with disordered sleep secondary to first episode stroke (n = 34 ischemic, n = 9 hemorrhagic; aged 66.2 ± 14.1 years) were randomized to receive 25 min of blue or red light for 5 or more days depending on inpatient rehabilitation length of stay (blue-light n = 21, red-light n = 22). At baseline and study discharge, daytime sleepiness was measured with the Karolinska Sleepiness Scale and Wits Pictorial Sleepiness Scale, fatigue with a visual analogue scale, and cognitive function with the Rey Auditory Verbal Learning Test and Trail Making Test (TMT). Wrist actigraphs measured nocturnal sleep parameters. Effect sizes were used to estimate sample sizes for larger studies.

Results

Blue light exposure led to significant improvements in daytime sleepiness, fatigue, auditory verbal learning, and time to sleep onset (all p < .05) relative to red light exposure (effect size range 0.75 to 1.83). Change in TMT, minutes of nocturnal sleep, and number of awakenings after sleep onset were not statistically significant (effect sizes range 0.38 to 0.57).

Conclusion

Morning blue light exposure for 5 or more days after acute stroke led to greater improvements than red light exposure. Effect sizes suggest a larger study is warranted to confirm generalizability of pilot findings.
Trial Registration: ClinicalTrials.gov NCT03125967 (Registered 01/01/2017).
背景:睡眠障碍和疲劳是中风急性期的常见症状,会阻碍患者的康复:睡眠障碍和疲劳是中风急性期的常见症状,会阻碍患者的康复:一项随机平行分组安慰剂对照试验研究比较了每天早晨照射蓝光或红光(安慰剂)对改善急性中风住院康复患者白天嗜睡、疲劳、夜间睡眠和认知能力的作用。方法:根据住院康复时间的长短,43 名因首次中风(缺血性 34 人,出血性 9 人;年龄 66.2 ± 14.1 岁)而继发睡眠障碍的患者被随机分配接受 5 天或更长时间的 25 分钟蓝光或红光照射(蓝光 21 人,红光 22 人)。在基线和出院时,使用卡罗林斯卡嗜睡量表和维茨图形嗜睡量表测量白天嗜睡程度,使用视觉模拟量表测量疲劳程度,使用雷伊听觉言语学习测试和追踪测试(TMT)测量认知功能。腕动仪测量夜间睡眠参数。研究结果表明,蓝光照射能显著改善睡眠质量:结果:暴露于蓝光可明显改善白天嗜睡、疲劳、听觉言语学习和睡眠开始时间(均为 p):急性中风后持续 5 天或更长时间的晨间蓝光照射比红光照射有更大的改善作用。效应大小表明,有必要进行更大规模的研究,以确认试验结果的普遍性:试验注册:ClinicalTrials.govNCT03125967(注册日期:2017年1月1日)。
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引用次数: 0
The risk information and skin-cancer education for undergraduate prevention (RISE-UP) study: Protocol for a trial of personalized sun protection interventions for skin cancer prevention among undergraduate students 本科生预防皮肤癌的风险信息和皮肤癌教育(RISE-UP)研究:大学生预防皮肤癌的个性化防晒干预试验方案。
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-02 DOI: 10.1016/j.cct.2024.107728
Yelena P. Wu , Liberty A. Woodside , Kimberly A. Kaphingst , Jakob D. Jensen , Jada G. Hamilton , Wendy Kohlmann , Ben Haaland , Ben J. Brintz , Siobhan M. Phillips , Jennifer L. Hay

Background

Addressing the increasing incidence of skin cancer among young adults is a priority. The objective of the Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP) study is to identify personalized intervention components to prevent sunburn, a clinically significant outcome highly associated with skin cancer, in college students.

Methods

Guided by the Elaboration Likelihood Model, the study will use Multiphase Optimization Strategy (MOST) methodology to test three intervention components (ultraviolet photography, MC1R genetic testing, and action planning) each with two levels (yes v. no) in a full-factorial experiment to evaluate unique and combined effects of these components to improve outcomes over the longer-term, with seasonally timed follow-up. At-risk University of Utah students (N = 528) will be recruited. Eligibility criteria include self-reported sunburn or tanning in the past year, or not utilizing recommended sun protection. After baseline assessment, participants will be randomized to intervention group, stratified by sex. Assessments will be completed at (1) Baseline; (2) Intervention; (3) 1 month after intervention; (4) 4 months after intervention (the end of the first summer); and (5) 15 months after intervention (the end of the second summer). The primary outcome will be participants' self-reported number of sunburns. Secondary outcomes will include self-reported sun protection and tanning behaviors and, in a randomly selected subgroup, an objective measure of ultraviolet radiation (UVR) exposure.

Conclusion

The RISE-UP study will determine the efficacy of different combinations of personalized skin cancer preventative interventions for young adults and determine the optimal combination of intervention components to prevent skin cancer.
Clinical Trial Registration: NCT05634252
背景:解决年轻人皮肤癌发病率不断上升的问题是当务之急。大学生预防皮肤癌的风险信息和皮肤癌教育(RISE-UP)研究的目的是确定个性化的干预措施,以预防大学生晒伤,晒伤是与皮肤癌高度相关的临床重要结果:该研究将以阐释可能性模型(Elaboration Likelihood Model)为指导,采用多阶段优化策略(Multiphase Optimization Strategy,MOST)方法,在全因子实验中测试三种干预措施(紫外线照相、MC1R 基因检测和行动规划),每种措施有两个水平(是与否),以评估这些措施的独特效果和综合效果,从而在较长时期内改善结果,并按季节时间进行随访。将招募犹他大学的高危学生(N = 528)。资格标准包括自我报告在过去一年中被晒伤或晒黑,或未使用建议的防晒措施。基线评估结束后,参与者将按性别随机分配到干预组。评估将在(1)基线;(2)干预;(3)干预后 1 个月;(4)干预后 4 个月(第一个夏季结束时);以及(5)干预后 15 个月(第二个夏季结束时)完成。主要结果是参与者自我报告的晒伤次数。次要结果将包括自我报告的防晒和晒黑行为,以及在随机抽取的分组中,对紫外线辐射(UVR)暴露的客观测量:RISE-UP研究将确定针对年轻人的不同个性化皮肤癌预防干预措施组合的疗效,并确定预防皮肤癌的最佳干预措施组合:临床试验注册:NCT05634252。
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引用次数: 0
Lifestyle empowerment for Alzheimer's prevention prescribed by physicians: Methods and adaptations to COVID-19 医生处方的阿尔茨海默氏症预防生活方式赋权:COVID-19 的方法和调整。
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-02 DOI: 10.1016/j.cct.2024.107729
Amanda N. Szabo-Reed , Amber Watts , Eric D. Vidoni , Jonathan Mahnken , Angela Van Sciver , Katrina Finley , Jonathan Clutton , Rachel Holden , Mickeal N. Key , Jeffery M. Burns
The health care system is insufficiently capitalizing on the benefits of physical exercise in America's aging population. Few tools exist to help clinicians incorporate physical activity into their clinical care, and barriers limit older adults from initiating and maintaining exercise programs. The Lifestyle Empowerment for Alzheimer's Prevention (LEAP! Rx) Program has been designed to support providers and participants in lifestyle change. LEAP! Rx uses two forms of participant enrollment: physician referrals through electronic health records and self-referrals to test the efficacy of delivering a community-based exercise and healthy lifestyle program to older adults. After referral into the program, participants are randomized to receive the LEAP! Rx Program or are placed in a standard-of-care group to receive the program later. The LEAP! Rx program consists of a personalized and structured exercise program, lifestyle education, and mobile health monitoring. This includes a 12-week Empowerment phase with coaching and supervised exercise training, followed by a 40-week Lifestyle phase with intermittent supervised exercise and coaching. Lifestyle education includes monthly, evidence-based classes on optimal aging. The evaluation of LEAP! Rx focuses on 1) the assessment of implementation and scalability of the LEAP!Rx Program for clinicians and patients 2) the effect of the LEAP! Rx Program on cardiorespiratory fitness, 3) the impact of the LEAP! Rx Program on secondary intervention outcome measures of chronic disease risk factors, including insulin resistance, body composition, and lipids. If successful, this study's findings could advance future healthcare practices, providing a new and practical approach to aging and chronic disease prevention.
医疗保健系统没有充分利用体育锻炼对美国老龄人口的益处。很少有工具可以帮助临床医生将体育锻炼纳入其临床护理中,而各种障碍也限制了老年人启动和维持锻炼计划。阿尔茨海默氏症预防生活方式赋权(LEAP!LEAP!Rx 采用两种形式招募参与者:医生通过电子健康记录转介和自我转介,以测试向老年人提供基于社区的运动和健康生活方式计划的效果。在被转介到该计划后,参与者将随机接受 LEAP!Rx 计划,或被安排在标准护理组,稍后再接受该计划。LEAP!Rx 计划包括个性化的结构化锻炼计划、生活方式教育和移动健康监测。其中包括为期 12 周的赋能阶段,包括指导和有监督的运动训练,随后是为期 40 周的生活方式阶段,包括间歇性的有监督的运动和指导。生活方式教育包括每月一次的最佳老龄化循证课程。LEAP!Rx 计划的评估重点是:1)评估临床医生和患者对 LEAP!Rx 计划对心肺功能的影响,3)LEAP!Rx计划对慢性病风险因素(包括胰岛素抵抗、身体成分和血脂)的二级干预结果测量的影响。如果研究成功,这项研究的结果将推动未来医疗保健实践的发展,为老龄化和慢性疾病预防提供一种新的实用方法。
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引用次数: 0
Healthy Drinks, Healthy Teeth – Ciunerkaq Tanqigtuq (The Future is Bright): A study protocol for a community-based, non-randomized sociobehavioral trial to reduce added sugar intake in Alaska Native Yup'ik children in the Yukon-Kuskokwim Delta 健康饮料,健康牙齿 - Ciunerkaq Tanqigtuq(前途光明):以社区为基础的非随机社会行为试验研究方案,旨在减少育空-库斯科克维姆三角洲阿拉斯加原住民尤皮克儿童的添加糖摄入量。
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-01 DOI: 10.1016/j.cct.2024.107734
Donald L. Chi , Frances Marcus Lewis , Philip Weinstein , Lloyd Mancl , Peter Milgrom , Todd Edwards , Susan Coldwell , Diane O'Brien , Andrea Bersamin , Scarlett Hopkins , Eliza Orr , Patricia Rivera , Dane Lenaker , Allison Sylvetsky , Joel Gittelsohn , Peter Walter , Cameron L. Randall , Deanna Wiseman , Andrea Dock , Alice Ko , Ellen MacLachlan

Background

This study protocol describes a community-based intervention that will seek to reduce added sugar intake in Yup'ik Alaska Native children by targeting reductions in sugar-sweetened fruit drinks.

Methods

A two-group non-randomized design will be used to evaluate the intervention in three Yup'ik communities in Alaska focusing on children age 1 to less than age 12 years with a minimum enrollment target of 192 children. Families in the intervention arm will participate in a program consisting of five sessions plus four brief check-ins, all delivered by a Yup'ik Community Health Worker. Modifications to the local store environment will be made to give families a place to purchase sugar-free water enhancers. Families in the delayed treatment control arm will receive no intervention during the main study period. There will be five data collection visits (baseline, 1-month, 3-months, 6-months, and 12-months) that will include collection of survey and dietary data, and a hair and plaque sample from each participating child. The outcomes will be change, from baseline to 6 months, in added sugar intake based on a validated hair biomarker (grams of added sugar/day). We hypothesize children in the intervention arm will have greater reductions in added sugar intake compared to children in the control arm as measured by the hair biomarker.

Discussion

This is one of the first known community-based sociobehavioral interventions aimed specifically at reducing added sugar intake in Alaska Native communities by targeting sugar-sweetened fruit drinks.

Trial registration

ClinicalTrials.gov NCT05219448 (first posted on February 2, 2022).
背景:本研究方案介绍了一项基于社区的干预措施,旨在通过减少含糖水果饮料的摄入量来减少阿拉斯加原住民尤普艾克儿童的添加糖摄入量:本研究方案介绍了一项以社区为基础的干预措施,旨在通过减少含糖水果饮料的摄入量来减少阿拉斯加原住民尤皮克儿童的添加糖摄入量:将采用两组非随机设计,在阿拉斯加州的三个尤皮伊克社区对干预措施进行评估,重点关注 1 岁至 12 岁以下的儿童,最低招募目标为 192 名儿童。干预组的家庭将参加由五次课程和四次简短的检查组成的计划,所有课程均由一名尤普安克社区保健工作者负责实施。将对当地商店环境进行改造,为家庭提供购买无糖增水剂的场所。延迟治疗对照组的家庭在主要研究期间将不接受任何干预。将进行五次数据收集访问(基线、1 个月、3 个月、6 个月和 12 个月),包括收集调查和饮食数据,以及每个参与儿童的头发和牙菌斑样本。结果将是根据经过验证的头发生物标志物(添加糖的克数/天)计算的添加糖摄入量从基线到 6 个月的变化。我们假设,与对照组的儿童相比,干预组的儿童通过头发生物标志物测量的添加糖摄入量将有更大的减少:讨论:这是已知的首批基于社区的社会行为干预措施之一,旨在通过针对含糖水果饮料,减少阿拉斯加原住民社区的添加糖摄入量:试验注册:ClinicalTrials.govNCT05219448(首次发布于2022年2月2日)。
{"title":"Healthy Drinks, Healthy Teeth – Ciunerkaq Tanqigtuq (The Future is Bright): A study protocol for a community-based, non-randomized sociobehavioral trial to reduce added sugar intake in Alaska Native Yup'ik children in the Yukon-Kuskokwim Delta","authors":"Donald L. Chi ,&nbsp;Frances Marcus Lewis ,&nbsp;Philip Weinstein ,&nbsp;Lloyd Mancl ,&nbsp;Peter Milgrom ,&nbsp;Todd Edwards ,&nbsp;Susan Coldwell ,&nbsp;Diane O'Brien ,&nbsp;Andrea Bersamin ,&nbsp;Scarlett Hopkins ,&nbsp;Eliza Orr ,&nbsp;Patricia Rivera ,&nbsp;Dane Lenaker ,&nbsp;Allison Sylvetsky ,&nbsp;Joel Gittelsohn ,&nbsp;Peter Walter ,&nbsp;Cameron L. Randall ,&nbsp;Deanna Wiseman ,&nbsp;Andrea Dock ,&nbsp;Alice Ko ,&nbsp;Ellen MacLachlan","doi":"10.1016/j.cct.2024.107734","DOIUrl":"10.1016/j.cct.2024.107734","url":null,"abstract":"<div><h3>Background</h3><div>This study protocol describes a community-based intervention that will seek to reduce added sugar intake in Yup'ik Alaska Native children by targeting reductions in sugar-sweetened fruit drinks.</div></div><div><h3>Methods</h3><div>A two-group non-randomized design will be used to evaluate the intervention in three Yup'ik communities in Alaska focusing on children age 1 to less than age 12 years with a minimum enrollment target of 192 children. Families in the intervention arm will participate in a program consisting of five sessions plus four brief check-ins, all delivered by a Yup'ik Community Health Worker. Modifications to the local store environment will be made to give families a place to purchase sugar-free water enhancers. Families in the delayed treatment control arm will receive no intervention during the main study period. There will be five data collection visits (baseline, 1-month, 3-months, 6-months, and 12-months) that will include collection of survey and dietary data, and a hair and plaque sample from each participating child. The outcomes will be change, from baseline to 6 months, in added sugar intake based on a validated hair biomarker (grams of added sugar/day). We hypothesize children in the intervention arm will have greater reductions in added sugar intake compared to children in the control arm as measured by the hair biomarker.</div></div><div><h3>Discussion</h3><div>This is one of the first known community-based sociobehavioral interventions aimed specifically at reducing added sugar intake in Alaska Native communities by targeting sugar-sweetened fruit drinks.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT05219448</span><svg><path></path></svg></span> (first posted on February 2, 2022).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107734"},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial 疼痛神经科学教育项目在改善纤维肌痛患者执行功能和疼痛强度方面的效果(纤维脑项目):随机对照临床试验研究方案
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-31 DOI: 10.1016/j.cct.2024.107731
Marco Antonio Morales-Osorio , Robinson Ramirez-Velez , Johana Mejía-Mejía , Laura Aline Martinez-Martinez , Fabian Román , Pedro Javier Lopez-Perez , Leidy Tatiana Ordoñez-Mora

Background

Fibromyalgia (FM) is a chronic musculoskeletal condition typically characterized by chronic pain, sleep disturbances, chronic fatigue, and cognitive problems. The present study aims to examine the efficacy of a pain neuroscience education program (PNE) in improving executive functions and pain intensity in patients with FM and compare them with those of standard treatment protocols.

Methods

This blinded, controlled clinical trial will compare changes in executive function and pain intensity between two groups. The first group will receive standard treatment supplemented with PNE, consisting of ten sessions spread over five weeks, with each session lasting 40–45 min. The main objective of this method is to remodel cognitive and emotional reactions to pain, challenging the idea that pain is directly related to injury and highlighting the influence of emotions, sleep, and physical activity on pain perception. The second group will receive only standard pharmacological treatment. The study sample will include 62 adults diagnosed with FM, according to initial sample size estimates based on previous evidence. A baseline assessment of baseline characteristics will be performed, after which patients will be randomly assigned to the PNE group or the control group. The results of the intervention will be evaluated and statistically compared after 5 weeks. This protocol complies with all relevant ethical guidelines. It has been approved by two institutional committees (Reference: NR2006; Conbioethics:21-CEI-004-20,170,829).

Conclusion

It is anticipated that this intervention will be a cost-effective and superior alternative to standard treatments.
Clinical trial registration: NCT05084300
背景纤维肌痛(FM)是一种慢性肌肉骨骼疾病,以慢性疼痛、睡眠障碍、慢性疲劳和认知问题为典型特征。本研究旨在探讨疼痛神经科学教育项目(PNE)在改善 FM 患者执行功能和疼痛强度方面的疗效,并将其与标准治疗方案进行比较。方法这项盲法对照临床试验将比较两组患者在执行功能和疼痛强度方面的变化。第一组将接受以 PNE 为辅的标准治疗,包括五个星期的十个疗程,每个疗程持续 40-45 分钟。这种方法的主要目的是重塑对疼痛的认知和情绪反应,挑战疼痛与受伤直接相关的观点,并强调情绪、睡眠和身体活动对疼痛感知的影响。第二组将只接受标准的药物治疗。根据以往证据对样本量的初步估计,研究样本将包括 62 名被诊断患有 FM 的成年人。在对基线特征进行基线评估后,患者将被随机分配到 PNE 组或对照组。5 周后将对干预结果进行评估和统计比较。本方案符合所有相关的伦理准则。该方案已获得两个机构委员会的批准(参考文献:NR2006;Conbioethics:21-CEI-004-20,170,829):临床试验注册:NCT05084300
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引用次数: 0
Study protocol for a sequential multiple assignment randomized trial to decrease alcohol use before and after surgery 减少手术前后饮酒的连续多重分配随机试验研究方案
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-28 DOI: 10.1016/j.cct.2024.107732
Xintong Ju , Jake Solka , Estevan Pena , Ashley Kocher , Richard Davies , Jennifer Waljee , Frederic C. Blow , Kelley M. Kidwell , Maureen A. Walton , Anne C. Fernandez

Background

High-risk alcohol consumption in the weeks before and after surgery poses significant risks for postoperative recovery. Despite this, elective surgical patients are rarely offered alcohol-focused education, interventions, or treatment. This paper describes the protocol of a research study designed to evaluate the effectiveness of brief, non-pharmacological, therapeutic approaches to reduce alcohol use before and after surgery.

Methods

The Alcohol Screening and Preoperative Intervention Research (ASPIRE-2) study trial includes 440 elective, non-cancer, surgery patients ages 21–75 years-old who report high-risk alcohol use. This trial uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to test the effectiveness of adaptive interventions that include preoperative Virtual Health Coaching (VHC) or Enhanced Usual Care (EUC) followed by postoperative intervention strategies tailored to participant response to the preoperative study condition. Intervention “response” is defined as achieving low-risk alcohol use following the preoperative intervention. The primary aims of this study are to: 1) examine the effectiveness of adaptive interventions that begin with preoperative VHC compared to EUC in reducing high-risk alcohol use among elective surgical patients; and 2) identify the most effective postoperative strategy for lasting alcohol use reduction over a period of 12 months. Secondary and exploratory aims will identify the best performing pre-specified adaptive interventions, identify baseline and time-varying moderators of intervention effectiveness, and evaluate surgical outcomes.

Conclusion

The ASPIRE-2 study is an innovative approach to develop adaptive interventions to reduce alcohol use proximal to elective surgery when alcohol use poses short- and long-term risks to surgery and health.
背景手术前后几周内的高风险饮酒会对术后恢复造成重大风险。尽管如此,择期手术患者很少接受以酒精为重点的教育、干预或治疗。本文介绍了一项研究的方案,该方案旨在评估简短、非药物治疗方法对减少手术前后饮酒的有效性。方法酒精筛查和术前干预研究(ASPIRE-2)研究试验包括 440 名年龄在 21-75 岁之间、报告有高饮酒风险的择期非癌症手术患者。该试验采用顺序、多重分配、随机试验(SMART)设计,以测试适应性干预措施的有效性,这些干预措施包括术前虚拟健康指导(VHC)或增强型常规护理(EUC),然后根据参与者对术前研究条件的反应制定术后干预策略。干预 "反应 "的定义是术前干预后达到低风险饮酒。本研究的主要目的是1)与 EUC 相比,检查术前 VHC 开始的适应性干预在减少择期手术患者高风险饮酒方面的有效性;以及 2)确定 12 个月内持续减少饮酒的最有效术后策略。ASPIRE-2研究是一种创新方法,旨在开发适应性干预措施,以减少择期手术前的饮酒,因为饮酒会给手术和健康带来短期和长期风险。
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引用次数: 0
Efficacy of a conversational chatbot for cigarette smoking cessation: Protocol of the QuitBot full-scale randomized controlled trial 对话聊天机器人对戒烟的功效:QuitBot 全面随机对照试验方案。
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-28 DOI: 10.1016/j.cct.2024.107727
Jonathan B. Bricker , Brianna M. Sullivan , Kristin E. Mull , Juan Lavista-Ferres , Margarita Santiago-Torres
Globally, cigarette smoking results in over 8 million premature annual deaths. Addressing this issue requires high-impact, cost-effective population-level interventions for smoking cessation. Conversational chatbots offer a potential solution given the recent advancements in machine learning and large language models. Chatbots can deliver supportive, empathetic behaviors, personalized responses, and timely advice tailored to users' needs that is engaging through therapeutic conversations aimed at creating lasting social-emotional connections. Despite their promise, little is known about the efficacy and underlying mechanisms of chatbots for cigarette smoking cessation. We developed QuitBot, a quit smoking program of two to three-minute conversations covering topics ranging from motivations to quit, setting a quit date, choosing cessation medications, coping with triggers, maintaining abstinence, and recovering from a relapse. QuitBot employs conversational interactions, powered by an expert-curated large language model, allowing users to ask questions and receive personalized guidance on quitting smoking. Here, we report the design and execution of a randomized clinical trial comparing QuitBot (n = 760) against Smokefree TXT (SFT) text messaging program (n = 760), with a 12-month follow-up period. Both interventions include 42-days of content on motivations to quit, skills to cope with triggers, and relapse prevention. The key distinction between QuitBot and SFT is that QuitBot has communication and engagement features. This study aims to determine: whether QuitBot yields higher quit rates than SFT; and whether therapeutic alliance processes and engagement are mechanisms underlying cessation outcomes. Additionally, we will explore whether baseline factors including trust, social support, and demographics, moderate the efficacy of QuitBot.
Trial Registration number ClinicalTrials.gov NCT04308759
在全球范围内,吸烟每年导致 800 多万人过早死亡。要解决这一问题,就必须采取影响大、成本效益高的人群戒烟干预措施。鉴于机器学习和大型语言模型的最新进展,对话聊天机器人提供了一种潜在的解决方案。聊天机器人可以根据用户的需求,通过旨在建立持久社会情感联系的治疗性对话,提供支持性、移情行为、个性化回复和及时建议。尽管聊天机器人大有可为,但人们对其戒烟功效和内在机制知之甚少。我们开发了戒烟机器人 QuitBot,这是一个由两到三分钟对话组成的戒烟程序,对话主题包括戒烟动机、设定戒烟日期、选择戒烟药物、应对诱因、维持戒烟以及从复吸中恢复。QuitBot 采用对话互动的方式,由专家编辑的大型语言模型提供支持,允许用户提出问题并获得个性化的戒烟指导。在此,我们报告了一项随机临床试验的设计和执行情况,该试验比较了QuitBot(n = 760)和Smokefree TXT(SFT)短信项目(n = 760),并进行了为期12个月的随访。两种干预都包括42天的内容,涉及戒烟动机、应对诱因的技巧和预防复吸。QuitBot 和 SFT 的主要区别在于 QuitBot 的沟通和参与功能。本研究旨在确定:QuitBot 的戒烟率是否高于 SFT;治疗联盟过程和参与是否是戒烟结果的基础机制。此外,我们还将探讨包括信任、社会支持和人口统计学在内的基线因素是否会影响 QuitBot 的疗效。试验注册号ClinicalTrials.govNCT04308759。
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引用次数: 0
A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study 治疗开角型青光眼或眼压过高的一氧化氮供体比马前列素 NCX 470 的 3 期适应性剂量选择试验:MONT BLANC研究。
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-28 DOI: 10.1016/j.cct.2024.107730
Steven L. Mansberger , Robert Fechtner , Krisi Lopez , Doug Hubatsch

Purpose

To identify the optimal dose of NCX 470, a nitric oxide (NO)-donating bimatoprost, for comparison to latanoprost in a phase 3 trial for open-angle glaucoma (OAG) or ocular hypertension (OHTN) using an adaptive dose selection design.

Patients and methods

In this prospective, multicenter trial, subjects were randomized 1:1:1 to NCX 470 0.065 %, NCX 470 0.1 %, or latanoprost 0.005 % dosed topically to both eyes once daily. After at least 30 subjects were assigned to each group, interim analysis was undertaken at 2 weeks and an independent committee selected the final NCX 470 dose for the full 12-week trial.

Results

The interim analysis included 103 subjects. The least-squares mean (95 % confidence interval [CI]) difference in diurnal intraocular pressure (IOP) was −1.51 mmHg (−2.88, −0.14) in the NCX 470 0.065 % group (p = 0.0308) and − 1.71 mmHg (−3.04, −0.38) in the NCX 470 0.1 % group (p = 0.0123), both favoring NCX 470 over latanoprost. The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (p > 0.05). NCX 470 0.1 % was selected as the final dose and the NCX 470 0.065 % dose arm was terminated with subsequent subjects randomized 1:1 to NCX 470 0.1 % or latanoprost.

Conclusion

Both concentrations of the NO-donating bimatoprost NCX 470 lower IOP more than latanoprost following 2 weeks of daily therapy. This adaptive dose selection design allowed identification of the optimal dose of NCX 470 with reduced trial costs, recruitment time, and the number of patients exposed to study medication.
目的:在一项治疗开角型青光眼(OAG)或眼压过高(OHTN)的3期试验中,采用自适应剂量选择设计,确定一氧化氮(NO)捐献型比马前列素NCX 470的最佳剂量,并与拉坦前列素进行比较:在这项前瞻性多中心试验中,受试者按1:1:1的比例随机分配到NCX 470 0.065 %、NCX 470 0.1 %或拉坦前列素0.005 %,每天一次,双眼局部用药。在每组至少分配了30名受试者后,在2周时进行了中期分析,并由一个独立委员会选定了整个12周试验的最终NCX 470剂量:结果:中期分析包括103名受试者。NCX 470 0.065%组的昼间眼压(IOP)最小二乘平均值(95%置信区间[CI])为-1.51 mmHg (-2.88, -0.14)(p = 0.0308),NCX 470 0.1%组为-1.71 mmHg (-3.04, -0.38)(p = 0.0123),NCX 470均优于拉坦前列素。最常见的副作用是结膜/眼球充血,两个NCX 470剂量组出现这种副作用的频率和严重程度相似(p > 0.05)。NCX 470 0.1%被选为最终剂量,NCX 470 0.065%剂量组被终止,随后受试者按1:1随机分配到NCX 470 0.1%或拉坦前列素:结论:两种浓度的NO-供体比马前列素NCX在每日治疗2周后降低眼压的效果均优于拉坦前列素。这种自适应剂量选择设计可以确定NCX 470的最佳剂量,同时减少试验成本、招募时间和接触研究药物的患者人数。
{"title":"A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study","authors":"Steven L. Mansberger ,&nbsp;Robert Fechtner ,&nbsp;Krisi Lopez ,&nbsp;Doug Hubatsch","doi":"10.1016/j.cct.2024.107730","DOIUrl":"10.1016/j.cct.2024.107730","url":null,"abstract":"<div><h3>Purpose</h3><div>To identify the optimal dose of NCX 470, a nitric oxide (NO)-donating bimatoprost, for comparison to latanoprost in a phase 3 trial for open-angle glaucoma (OAG) or ocular hypertension (OHTN) using an adaptive dose selection design.</div></div><div><h3>Patients and methods</h3><div>In this prospective, multicenter trial, subjects were randomized 1:1:1 to NCX 470 0.065 %, NCX 470 0.1 %, or latanoprost 0.005 % dosed topically to both eyes once daily. After at least 30 subjects were assigned to each group, interim analysis was undertaken at 2 weeks and an independent committee selected the final NCX 470 dose for the full 12-week trial.</div></div><div><h3>Results</h3><div>The interim analysis included 103 subjects. The least-squares mean (95 % confidence interval [CI]) difference in diurnal intraocular pressure (IOP) was −1.51 mmHg (−2.88, −0.14) in the NCX 470 0.065 % group (<em>p</em> = 0.0308) and − 1.71 mmHg (−3.04, −0.38) in the NCX 470 0.1 % group (<em>p</em> = 0.0123), both favoring NCX 470 over latanoprost. The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (<em>p</em> &gt; 0.05). NCX 470 0.1 % was selected as the final dose and the NCX 470 0.065 % dose arm was terminated with subsequent subjects randomized 1:1 to NCX 470 0.1 % or latanoprost.</div></div><div><h3>Conclusion</h3><div>Both concentrations of the NO-donating bimatoprost NCX 470 lower IOP more than latanoprost following 2 weeks of daily therapy. This adaptive dose selection design allowed identification of the optimal dose of NCX 470 with reduced trial costs, recruitment time, and the number of patients exposed to study medication.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107730"},"PeriodicalIF":2.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neural and metabolic factors in carbohydrate reward: Rationale, design, and methods for a flavor-nutrient learning paradigm in humans 碳水化合物奖赏的神经和代谢因素:人类口味-营养素学习范例的原理、设计和方法。
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 DOI: 10.1016/j.cct.2024.107717
Amber L. Kelly , Mary Elizabeth Baugh , Monica L. Ahrens , Abigail N. Valle , Rhianna M. Sullivan , Mary E. Oster , Mary E. Fowler , Bridget E. Carter , Brenda M. Davy , Alexandra L. Hanlon , Alexandra G. DiFeliceantonio
Overconsumption of ultra-processed foods (UPFs), which are linked with adverse health outcomes, is a growing public health concern. UPFs deliver highly bioavailable calories rapidly, which may contribute to their reinforcing potential and drive overconsumption. Our primary aim is to test the role of speed of nutrient availability on reward learning. We hypothesize that brain activity in reward related areas and behavioral preferences will be greater to a flavored drink predicting rapidly available calories (CS + Fast) compared with a flavored drink predicting more slowly available (CS + Slow) or no (CS-) calories. Participants (n = 64, aged 18–45 years, will consume 3 novel flavored, isosweet beverages containing 110 kcal of sucrose (CS + Fast), 110 kcal of maltodextrin (CS + Slow), or 0-kcal sucralose (CS-) 6 times in randomized, crossover order. Blood metabolites and indirect calorimetry measures, including metabolic rate and carbohydrate oxidation, will be assessed before and for 1 h after beverage consumption. Behavioral preference for beverages will be assessed in a pre- and post-test. Brain response to each flavor without calories will be assessed via functional magnetic resonance imaging in a post-test. Findings from this study will contribute to the understanding of basic mechanisms that may drive overconsumption of UPFs.
Trial registration: clinicaltrials.gov registration #NCT06053294
过度消费超加工食品(UPFs)与不良健康后果有关,是一个日益严重的公共健康问题。超加工食品能迅速提供高生物利用率的卡路里,这可能有助于其强化潜能并推动过度消费。我们的主要目的是测试营养素供应速度对奖赏学习的作用。我们假设,与预测热量供应速度较慢(CS + 慢)或无热量(CS-)的风味饮料相比,预测热量供应速度较快的风味饮料(CS + 快)的奖励相关区域的大脑活动和行为偏好会更大。参与者(n = 64,18-45 岁)将以随机、交叉的顺序饮用 3 种新颖的等甜味饮料,分别含有 110 千卡的蔗糖(CS + 快)、110 千卡的麦芽糊精(CS + 慢)或 0 千卡的蔗糖素蔗糖(CS-),共饮用 6 次。血液代谢物和间接热量测量(包括代谢率和碳水化合物氧化)将在饮用饮料前和饮用饮料后 1 小时内进行评估。对饮料的行为偏好将在前后测试中进行评估。在后测试中,将通过功能磁共振成像评估大脑对每种不含卡路里的口味的反应。这项研究的结果将有助于了解可能导致过度摄入 UPFs 的基本机制。试验注册:clinicaltrials.gov 注册号:NCT06053294。
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引用次数: 0
Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children MetA-Bone试验中采用的招募策略的效果和成本,该试验是一项随机临床试验,旨在测试在儿童中补充为期一年的可溶性玉米纤维的效果
IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 DOI: 10.1016/j.cct.2024.107715
Cristina Palacios, Julia Leone, Priscilla Clayton, Jacqueline Hernandez, María Angélica Trak-Fellermeier, Alison Macchi, Daniela Ramirez-Roggio, Yivani Cobo, Shanelle Bautista, Jeneene Connelly, Malik Elington, Jorge Romero, Rodolfo Galvan
Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.
ClinicalTrials.gov registry number: NCT02916862
背景:招募儿童参与临床试验非常具有挑战性。我们设计了一项招募计划,招募健康儿童(9-14 岁)参加一项试验,测试补充玉米可溶性纤维对骨质的 1 年影响。我们评估了该试验所采用的招募策略的有效性和成本。方法:招募计划包括 "传统"(邮寄、传单、海报、访问、滚雪球等)或 "在线"(电子邮件宣传、社交媒体、网站等)策略。所有策略都指向预选在线表格,其中询问他们是如何了解到这项研究的。本分析包括预选和注册(签署同意书)人数、不合格人数、社会人口统计以及每种策略的成本。差异分析采用方差分析或卡方检验。结果649 人完成了预筛选;37.1% 来自 "传统 "策略,46.7% 来自 "在线 "策略,2.6% 来自 "其他 "策略,13.6% 来自 "未知 "策略。最成功的策略与佛罗里达国际大学有关(在校园内张贴传单和电子邮件宣传)。不符合条件的主要原因是肥胖(38.9%)或超出年龄范围(22.7%)。共有 48.4% 的儿童通过 "传统"、50.2% 通过 "在线 "和 1.4% 通过 "其他 "策略报名。传统 "策略和 "在线 "策略每筛选一名参与者的成本分别为 1112 美元和 512 美元,"传统 "策略和 "在线 "策略每招收一名参与者的成本分别为 2704 美元和 1454 美元。成本最高的是员工工资。结论与 "传统 "策略相比,"在线 "策略更有效,实施成本更低,尽管这些策略对于实现招募目标也很重要。未来的儿科试验应考虑这些策略及其成本:NCT02916862
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引用次数: 0
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Contemporary clinical trials
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