home-based

Home - based
  • 文章类型: Journal Article
    背景:结核病(TB)预防性治疗(TPT)是针对暴露于TB的儿童的长期建议,但实施不力。基于家庭的联系管理可以增加家庭中接触结核病的儿童对TPT的访问和覆盖率。
    方法:对包括项目经理在内的主要信息提供者进行了60次深入访谈,结核病提供者(称为结核病联络人),儿童最近在奥罗米亚从事结核病预防服务的健康推广工作者和护理人员,埃塞俄比亚将于2021年了解为15岁以下儿童提供家庭结核病预防服务的障碍和促进者。进行了主题内容分析,包括对每次访谈进行系统编码。
    结果:基于家庭的服务被认为是以家庭为中心的干预措施,解决客户的时间和财务限制。利益相关者提议在卫生推广人员和基于设施的结核病联络人之间进行任务共享的干预。他们建议将结核病服务集成到其他基于家庭的服务中,包括艾滋病毒,营养,和疫苗接种服务,以减少已经过度紧张的健康推广工作者的工作量。社区意识被认为对于提高社区成员对家庭服务和TPT的接受度至关重要。
    结论:TPT的权力下放应通过卫生推广工作者和基于设施的结核病重点人员之间的任务共享启动和后续行动以及基于家庭的服务的整合来支持。通过几种现有机制积极的社区参与可以帮助提高家庭干预措施和儿童整体TPT推广的可接受性。
    背景:此处提供的结果来自与2020年4月30日注册的CHIP-TB试验(标识符NCT04369326)相关的形成性研究。这项定性研究于2020年7月27日在NCT04494516单独注册。
    BACKGROUND: Tuberculosis (TB) preventive treatment (TPT) is a long-standing recommendation for children exposed to TB but remains poorly implemented. Home-based contact management may increase access and coverage of TPT among children exposed to TB in their households.
    METHODS: Sixty in-depth interviews were conducted with key informants including program managers, TB providers (known as TB focal persons), health extension workers and caregivers whose children had recently engaged with TB prevention services in Oromia, Ethiopia in 2021 to understand the barriers and facilitators to providing home-based TB prevention services for children aged < 15 years. Thematic content analysis was conducted including systematically coding each interview.
    RESULTS: Home-based services were considered a family-centered intervention, addressing the time and financial constraints of clients. Stakeholders proposed a task-shared intervention between health extension workers and facility-based TB focal persons. They recommended that TB services be integrated into other home-based services, including HIV, nutrition, and vaccination services to reduce workload on the already overstretched health extension workers. Community awareness was considered essential to improve acceptability of home-based services and TPT in general among community members.
    CONCLUSIONS: Decentralization of TPT should be supported by task-sharing initiation and follow up between health extension workers and facility-based TB focal persons and integration of home-based services. Active community engagement through several existing mechanisms can help improve acceptability for both home-based interventions and TPT promotion overall for children.
    BACKGROUND: The results presented here were from formative research related to the CHIP-TB Trial (Identifier NCT04369326) registered on April 30, 2020. This qualitative study was separately registered at NCT04494516 on 27 July 2020.
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  • 文章类型: Case Reports
    这个单参与者案例研究研究了在家庭环境中使用定制虚拟现实(VR)游戏软件进行低剂量手臂双臂强化训练(HABIT)的可行性。一名10岁的右单侧脑瘫患者参加了这项试验。在干预前后,使用方框和方框测试评估精细和总体运动技能以及运动结果的个人目标。九孔钉试验,和加拿大职业绩效衡量。通过VR硬件加速度计收集的运动强度,VR游戏得分,通过HABIT-VR软件记录任务准确性作为运动性能指标。孩子和家人被指示在14天的时间内每天两次使用HABIT-VR游戏30分钟,并要求记录他们使用该系统的时间。孩子使用了这个系统,完成了14个小时,低剂量HABIT-VR干预22天。干预前后的方框和方框测试和九孔钉测试分数没有变化。加拿大职业绩效测量得分增加,但未达到临床相关阈值,由于基线得分高。在使用VR期间运动任务强度的变化和对VR双向任务的掌握表明提高了运动效率。此案例研究提供了初步证据,证明HABIT-VR可用于促进对HABIT活动的坚持以及在家庭环境中维持上肢运动技能。
    This single-participant case study examines the feasibility of using custom virtual reality (VR) gaming software in the home environment for low-dose Hand Arm Bimanual Intensive Training (HABIT). A 10-year-old with right unilateral cerebral palsy participated in this trial. Fine and gross motor skills as well as personal goals for motor outcomes were assessed before and after the intervention using the Box and Blocks Test, Nine-Hole Peg Test, and Canadian Occupational Performance Measure. Movement intensities collected via the VR hardware accelerometers, VR game scores, and task accuracy were recorded via the HABIT-VR software as indices of motor performance. The child and family were instructed to use the HABIT-VR games twice daily for 30 minutes over a 14-day period and asked to record when they used the system. The child used the system and completed the 14-hour, low-dose HABIT-VR intervention across 22 days. There was no change in Box and Blocks Test and Nine-Hole Peg Test scores before and after the intervention. Canadian Occupational Performance Measure scores increased but did not reach the clinically relevant threshold, due to high scores at baseline. Changes in motor task intensities during the use of VR and mastery of the VR bimanual tasks suggested improved motor efficiency. This case study provides preliminary evidence that HABIT-VR is useful for promoting adherence to HABIT activities and for the maintenance of upper extremity motor skills in the home setting.
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  • 文章类型: Journal Article
    背景:十年来,尽管有很多研究的结果,由于不同的研究结果,远程医疗系统缺乏对慢性心力衰竭(CHF)护理的建议。另一个限制是大多数远程医疗系统的基于医院的架构。一些系统使用基于每日体重的算法,经皮氧测量,和心率,以尽早发现和治疗CHF患者的急性心力衰竭(AHF)。
    目的:本研究的目的是确定远程监测系统在现实生活中(院外管理)检测临床不稳定而不会产生过多的假阳性警报的有效性。
    方法:回顾性纳入2020年3月至2021年3月在法国心脏病学诊所治疗的充血性AHF事件后,所有患者在家中使用该系统进行自我监测,每天测量的依从性至少为75%。新发作的AHF由以下标准中的至少一个定义:经皮氧饱和度损失,定义为经皮氧测量值低于90%;心跳频率高于每分钟110次;体重增加至少2公斤;和充血性AHF症状,通过电话描述。当标准达到我们对新发急性充血性心力衰竭(HF)的定义时,会生成AHF警报。
    结果:共纳入111名连续患者(n=70名男性),中位年龄76.60岁(IQR69.5-83.4)。三十九名病人(35.1%)达到高频警告水平,28例患者(25%)在随访期间证实了HF失稳。没有患者没有被远程监测系统检测到的AHF。在不正确的AHF警报中(n=11),5名患者(45%)进行了不准确的测量,3例患者(27%)有室上性心律失常,1例患者(9%)有肺部细菌感染,1例患者(9%)感染COVID-19。4天内体重增加至少2公斤与正确的AHF警报显着相关(P=.004),心率超过110次/分钟与错误的AHF警报更显著相关(P=.007)。
    结论:这项单中心研究通过检测新发AHF和室上性心律失常,强调了远程医疗系统在检测和快速治疗复杂CHF病程的心脏不稳定方面的功效。从而帮助心脏病专家为门诊患者提供更好的随访。
    BACKGROUND: For a decade, despite results from many studies, telemedicine systems have suffered from a lack of recommendations for chronic heart failure (CHF) care because of variable study results. Another limitation is the hospital-based architecture of most telemedicine systems. Some systems use an algorithm based on daily weight, transcutaneous oxygen measurement, and heart rate to detect and treat acute heart failure (AHF) in patients with CHF as early on as possible.
    OBJECTIVE: The aim of this study is to determine the efficacy of a telemonitoring system in detecting clinical destabilization in real-life settings (out-of-hospital management) without generating too many false positive alerts.
    METHODS: All patients self-monitoring at home using the system after a congestive AHF event treated at a cardiology clinic in France between March 2020 and March 2021 with at least 75% compliance on daily measurements were included retrospectively. New-onset AHF was defined by the presence of at least 1 of the following criteria: transcutaneous oxygen saturation loss, defined as a transcutaneous oxygen measurement under 90%; rise of cardiac frequency above 110 beats per minute; weight gain of at least 2 kg; and symptoms of congestive AHF, described over the phone. An AHF alert was generated when the criteria reached our definition of new-onset acute congestive heart failure (HF).
    RESULTS: A total of 111 consecutive patients (n=70 men) with a median age of 76.60 (IQR 69.5-83.4) years receiving the telemonitoring system were included. Thirty-nine patients (35.1%) reached the HF warning level, and 28 patients (25%) had confirmed HF destabilization during follow-up. No patient had AHF without being detected by the telemonitoring system. Among incorrect AHF alerts (n=11), 5 patients (45%) had taken inaccurate measurements, 3 patients (27%) had supraventricular arrhythmia, 1 patient (9%) had a pulmonary bacterial infection, and 1 patient (9%) contracted COVID-19. A weight gain of at least 2 kg within 4 days was significantly associated with a correct AHF alert (P=.004), and a heart rate of more than 110 beats per minute was more significantly associated with an incorrect AHF alert (P=.007).
    CONCLUSIONS: This single-center study highlighted the efficacy of the telemedicine system in detecting and quickly treating cardiac instability complicating the course of CHF by detecting new-onset AHF as well as supraventricular arrhythmia, thus helping cardiologists provide better follow-up to ambulatory patients.
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  • 文章类型: Journal Article
    背景:家庭护理人员(FC)在提供基于家庭的临终关怀方面发挥着至关重要的作用。然而,在担任这一角色时,对FCs的经验知之甚少。集成的社区临终支持团队(ICEST)是一个需求驱动的,以家庭为基础,香港以家庭为中心的护理模式。我们评估了其对FC的影响,并比较了配偶和成年子女的结局。方法:采用多中心试验前-后研究方法。符合条件的参与者是预期寿命≤12个月的绝症老年人(年龄≥60岁)的主要FCs。基线(T0)和干预后三个月(T1)结局指标包括FCs护理应变,心理困扰,感知到的外部支持,亲密关系,以及关于护理规划的沟通。结果:在T0时登记了628个FC样本,40.0%完成了T1评估。ICEST模型有效地减少了护理压力,抑郁症,以及对病人的担忧,虽然与患者的护理计划协议有所改善,和感知的外部支持。在T0时,配偶对照顾的负面看法更多,并且面临的调整需求比成年子女少。与配偶相比,成年儿童与患者更亲密。在T0和T1之间,配偶对患者的担忧减少了更多,比成年儿童。结论:ICEST模型有助于获得更好的结果,个人和关系,对于FC,无论关系类型。配偶和成年子女在提供家庭临终关怀时面临着不同的挑战。有效的干预措施应改变配偶照顾者对照顾的负面看法,并使成年子女能够处理多项任务和复杂的期望。
    Backgrounds: Family caregivers (FCs) play an essential role in delivering home-based end-of-life care. However, little is known about FCs\'\' experiences when undertaking this role. The integrated community end-of-life support team (ICEST) is a needs-driven, home-based, family-centered care model in Hong Kong. We evaluated its effects on FCs and compared outcomes for spouses and adult children. Method: A multicenter pre-post-test study was conducted. Eligible participants were primary FCs of terminally ill older adults (age ≥ 60) who had a life expectancy of ≤12 months. Baseline (T0) and three-month post-intervention (T1) outcome measures included FCs\'\' caregiving strain, psychological distress, perceived external support, intimate relationships, and communications regarding care planning. Results: A sample of 628 FCs were enrolled at T0, and 40.0% completed the T1 assessments. The ICEST model was effective in reducing caregiving strain, depression, and worries about patients, whilst there were improvements in agreement about care planning with patients, and perceived external supports. At T0, spouses held more negative perceptions of caregiving and faced fewer adjustment demands than adult children. Compared with spouses, adult children were more intimate with patients. Between T0 and T1, spouses experienced a greater reduction in worries about patients, than adult children. Conclusions: The ICEST model contributed to better outcomes, individually and relationally, for FCs, regardless of relationship type. Spouses and adult children faced different challenges while delivering home-based end-of-life care. Effective interventions should modify the negative perceptions of caregiving in spousal caregivers and enable adult children to deal with multiple tasks and complex expectations.
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  • 文章类型: Journal Article
    简介:本系统综述和荟萃分析旨在调查家庭视频锻炼计划的依从性和保留率,并确定与老年人这些比率相关的关键因素,以了解家庭视频锻炼干预的有效性。方法:我们搜索了PubMed,WebofScience,和Scopus的文章涉及坚持和保留基于家庭的视频练习程序。这项研究是根据PRISMA的建议进行的。结果:共26篇,包括1,292名65岁以上的参与者,被纳入最终的定性和定量综合。保留率的加权平均值为91.1,出勤率为85.0,低I2=3.5,差异无统计学意义p=0.409。广义回归模型显示,会期对出席率(%)有积极影响,从<20分钟到>60分钟的可能变化可能会降低出勤率(%)B=-24.390(p<0.001)。分娩方式效果显著,与在线课程B=-11.482(p=0.010)相比,在基于网络或DVD的干预中缺乏与教练的实时联系可能会降低出勤率(%)。COVID-19大流行期间的封锁对出勤率(%)B=10.321(p=0.019)和保留率(%)B=9.577(p=0.032)均有积极影响。结论:这项系统评价和荟萃分析表明,持续少于60分钟的有监督的家庭视频锻炼计划可能是保持老年人活跃的合适且可持续的锻炼模式。尤其是在类似于禁闭的感觉的时候。
    Introduction: This systematic review and meta-analysis aimed to investigate adherence and retention rates to home-based video exercise programs and identify key factors associated with these rates in older adults to understand the effectiveness of home-based video exercise interventions. Methods: We searched PubMed, Web of Science, and Scopus for articles addressing adherence to and retention of home-based video exercise programs. The study was conducted following PRISMA recommendations. Results: A total of 26 articles, including 1,292 participants older than 65, were included in the final qualitative and quantitative syntheses. The weighted mean of the retention rate was 91.1, and of the attendance rate was 85.0, with low I2 = 3.5, not significant p = 0.409 heterogeneity. The generalized regression models showed a positive effect of session duration on the attendance rate (%), where the possible change from <20 min to >60 min duration could decrease the attendance rate (%) B = -24.390 (p <0.001). The delivery method had a significant effect, where the absence of live contact with the coach in web-based or DVD-delivered interventions could decrease the attendance rate (%) compared to the online sessions B = -11.482 (p = 0.010). The lockdown during the COVID-19 pandemic had a positive effect on both the attendance rate (%) B = 10.321 (p = 0.019) and retention rate (%) B = 9.577 (p = 0.032). Conclusions: This systematic review and meta-analysis indicate that supervised home-based video exercise programs lasting less than 60 min might be a suitable and sustainable exercise mode to keep older adults active, especially in times resembling feelings of confinement.
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  • 文章类型: Clinical Trial Protocol
    背景:患有多发性硬化症(MS)的老年人体力活动参与率较低,认知和步行功能障碍,生活质量(QOL)受损。
    目的:我们提出NIH第一阶段,随机对照试验(RCT),检查了基于16周理论的可行性和有效性,远程交付,运动训练计划,用于改善患有中度活动障碍且无严重认知障碍的MS老年人的认知和身体功能。
    方法:本I期研究采用平行组RCT设计。参与者(N=50;年龄≥50岁)将被随机分配到运动训练(有氧和阻力运动相结合)或主动控制(柔韧性和伸展)条件。这些条件将在16周内在参与者的家中/社区内进行,并远程监控,并通过行为教练由社会认知理论(SCT)指导的基于缩放的聊天支持。参加者将获得培训手册和设备,一对一的行为辅导,行动计划日历,自我监控日志,和基于SCT的新闻通讯。主要结果包括可行性(例如,招聘和保留率),锻炼行为和身体活动;其他结果包括身体功能(下肢功能,移动性,步行),认知(处理速度,学习和记忆,执行功能),MS症状,QOL,和血管功能。我们将在基线(第0周)收集结果数据,干预后(第16周),和随访(第32周)。数据分析将遵循使用线性混合效应模型的意向治疗原则。
    结论:此阶段-I试验采用了一种通过远程康复进行运动训练的创新方法,对于患有MS的老年人来说很方便。如果成功,该研究将为未来的研究提供基础,使用远程提供的运动干预来管理MS衰老的后果。
    背景:NCT05930821。
    BACKGROUND: Older adults with multiple sclerosis (MS) present with low physical activity participation, cognitive and ambulatory dysfunctions, and compromised quality of life (QOL).
    OBJECTIVE: We propose a NIH Stage-I, randomized controlled trial (RCT) that examines the feasibility and efficacy of a 16-week theory-based, remotely-delivered, exercise training program for improving cognitive and physical functions in older adults with MS who have moderate mobility disability without severe cognitive impairment.
    METHODS: This Stage-I study utilizes a parallel-group RCT design. Participants (N = 50; age ≥ 50 years) will be randomly assigned into exercise training (combined aerobic and resistance exercise) or active control (flexibility and stretching) conditions. The conditions will be undertaken within a participant\'s home/community over a 16-week period, and monitored remotely and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and SCT-based newsletters. The primary outcomes include feasibility (e.g., recruitment and retention rates), exercise behavior and physical activity; other outcomes include physical function (lower-extremity function, mobility, walking), cognition (processing speed, learning and memory, executive function), MS symptoms, QOL, and vascular function. We will collect outcome data at baseline (Week 0), post-intervention (Week 16), and follow-up (Week-32). Data analysis will follow intent-to-treat principles using linear mixed-effects models.
    CONCLUSIONS: This Stage-I trial adopts an innovative approach for exercise training via telerehabilitation and is convenient and accessible for older adults with MS. If successful, the study will provide foundations for future research using remotely-delivered exercise intervention for managing the consequences of aging with MS.
    BACKGROUND: NCT05930821.
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  • 文章类型: Journal Article
    目的:运动相关的皮质活动异常与帕金森病(PD)的运动功能受损有关。多巴胺能药物治疗可以恢复这些,但是剂量和长期治疗受到不良副作用的限制。有效的非药物治疗有助于减少对药物的依赖。该实验报告了基于家庭的脑电图(EEG)神经反馈训练作为PD的非药物候选治疗的第一项研究。我们的主要目的是在家庭环境中测试我们的EEG神经反馈干预的可行性。
    方法:16名PD患者接受了6次家访,包括症状自我报告,标准化的运动评估,并在记录EEG的同时进行精确的握力产生任务(第1、2和6次访问);和3×1小时的EEG神经反馈训练课程,以抑制EEGmu节奏,然后再开始抓握动作(第3至5次访问)。
    结果:参与者成功地学会了自我调节mu活动,这似乎加快了精密运动的启动(即,药物干预前达到目标握力的时间=628毫秒,干预后停药=564ms)。没有更广泛的症状学减少的证据(例如,运动障碍协会统一帕金森病评定量表第三部分运动检查,干预前停药=29.00,干预后停药=30.07)。访谈表明,干预措施广受好评。
    结论:基于神经反馈对运动相关皮质活动的显著影响,来自参与者的积极定性报告,以及运动启动的暗示性好处,我们得出结论,PD患者的家庭神经反馈治疗是一种可行且有前景的非药物治疗方法,值得进一步研究.
    OBJECTIVE: Aberrant movement-related cortical activity has been linked to impaired motor function in Parkinson\'s disease (PD). Dopaminergic drug treatment can restore these, but dosages and long-term treatment are limited by adverse side-effects. Effective non-pharmacological treatments could help reduce reliance on drugs. This experiment reports the first study of home-based electroencephalographic (EEG) neurofeedback training as a non-pharmacological candidate treatment for PD. Our primary aim was to test the feasibility of our EEG neurofeedback intervention in a home setting.
    METHODS: Sixteen people with PD received six home visits comprising symptomology self-reports, a standardised motor assessment, and a precision handgrip force production task while EEG was recorded (visits 1, 2 and 6); and 3 × 1-hr EEG neurofeedback training sessions to supress the EEG mu rhythm before initiating handgrip movements (visits 3 to 5).
    RESULTS: Participants successfully learned to self-regulate mu activity, and this appeared to expedite the initiation of precision movements (i.e., time to reach target handgrip force off-medication pre-intervention = 628 ms, off-medication post-intervention = 564 ms). There was no evidence of wider symptomology reduction (e.g., Movement Disorder Society Unified Parkinson\'s Disease Rating Scale Part III Motor Examination, off-medication pre-intervention = 29.00, off-medication post intervention = 30.07). Interviews indicated that the intervention was well-received.
    CONCLUSIONS: Based on the significant effect of neurofeedback on movement-related cortical activity, positive qualitative reports from participants, and a suggestive benefit to movement initiation, we conclude that home-based neurofeedback for people with PD is a feasible and promising non-pharmacological treatment that warrants further research.
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  • 文章类型: Journal Article
    干血斑点(DBS)提供了一种评估炎症标记的微创方法,可以在家或在实验室中远程收集。然而,缺乏比较这些不同收集方法和老年人的方法信息。我们调查了可行性(包括依从性,产量,质量,和参与者偏好)和测量属性(可靠性,有效性)远程收集的老年人DBS炎症标志物。参与者(N=167,平均年龄=72,范围:60-96岁)在〜6个月的三个远程访谈中收集了自己的DBS(手指扎在滤纸上)。在他们上次远程采访的平均4-5天内,41名参与者的子集还参加了亲自实验室访问,其中包括研究人员收集的DBS样本,静脉抽血,并进行调查,以评估参与者对DBS收集的偏好。DBS和静脉血检测CRP,IL-6和TNF-α。坚持:98%的预期DBS样品(501个中的493个)完成并邮寄回实验室。产率:97%的DBS样品对于所有测定都是足够的。质量:平均而言,远程获得的最佳点(充满整个圆圈的60uL血液)少于0.80当面(p=0.013),但是可用或更好的斑点(至少30-40uL的血液)的数量没有差异(p=0.89)。偏好:一小部分参与者(54%)更喜欢亲自收集DBS。可靠性:DBS重测可靠性良好:CRP(ICC=0.74),IL-6(ICC=0.76),和TNF-α(ICC=0.70)。有效性:DBS的炎症水平与静脉血的水平密切相关(r=0.60-0.99),并与预期的社会人口统计学和身体健康以及功能变量相关。老年人可以远程收集自己的DBS以获取可靠和有效的炎症数据。远程DBS收集是高度可行的,并且可以允许对炎症标志物进行更大的评估,比基于实验室或临床的研究设计更有代表性的样本。
    Dried blood spots (DBS) provide a minimally invasive method to assess inflammatory markers and can be collected remotely at-home or in-person in the lab. However, there is a lack of methodological information comparing these different collection methods and in older adults. We investigated the feasibility (including adherence, yield, quality, and participant preferences) and measurement properties (reliability, validity) of remotely collected DBS inflammatory markers in older adults. Participants (N = 167, mean age = 72, range: 60-96 years) collected their own DBS (finger prick on filter paper) during three remote interviews over ∼ 6 months. Within 4-5 days on average of their last remote interview, a subset of 41 participants also attended an in-person lab visit that included a researcher-collected DBS sample, venous blood draw, and survey to assess participant preferences of DBS collection. DBS and venous blood were assayed for CRP, IL-6, and TNF-α. Adherence: 98% of expected DBS samples (493 out of 501) were completed and mailed back to the lab. Yield: 97% of DBS samples were sufficient for all assays. Quality: On average, 0.80 fewer optimal spots (60uL of blood that filled the entire circle) were obtained remotely vs. in-person (p = 0.013), but the number of useable or better spots (at least 30-40uL of blood) did not differ (p = 0.89). Preference: A slight majority of participants (54%) preferred in-person DBS collection. Reliability: DBS test-retest reliabilities were good: CRP (ICC = 0.74), IL-6 (ICC = 0.76), and TNF-α (ICC = 0.70). Validity: Inflammatory levels from DBS correlated strongly with levels from venous blood (r = 0.60-0.99) and correlated as expected with sociodemographic and physical health and function variables. Older adults can remotely collect their own DBS to acquire reliable and valid inflammatory data. Remote DBS collection is highly feasible and may allow for inflammatory markers to be assessed in larger, more representative samples than are possible with lab- or clinic-based research designs.
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  • 文章类型: Journal Article
    背景:评估出版物通常总结研究结果,以证明干预措施的有效性,但很少有人分享关于在研究期间实施的任何变化。我们提出了一种基于家庭的步态的过程评估协议,balance,根据过程评估的7个关键要素,进行抗阻运动干预以改善紫杉烷引起的持续性神经病变研究。
    方法:过程评估平行于纵向,随机对照临床试验检查家庭步态的影响,balance,以及针对紫杉烷类药物治疗乳腺癌后患有持续性周围神经病变的女性的抵抗运动计划(IRB批准:Pro00040035)。流程图阐明了如何在可比的环境中实施干预措施,保真程序有助于确保参与者感到舒适,并确定他们的个人需求,并且过程评估允许个人的注意力定制和研究的重点,以避免协议偏差。
    结论:评估方案计划的公布增加了临床试验结果的透明度,并有利于在未来的研究中复制过程。过程评估使团队能够系统地登记征聘期间应用的信息和程序以及影响干预措施实施的因素,从而允许主动的方法来防止偏离协议。当持续跟踪干预时,积极或消极的干预效果在研究的早期就显现出来了,为不一致的结果提供有价值的见解。此外,过程评估在研究协议中增加了以参与者为中心的元素,这允许将以患者为中心的方法应用于数据收集。
    背景:ClinicalTrials.govNCT04621721,2020年11月9日,前瞻性注册。
    方法:2020年4月27日,第2卷。
    BACKGROUND: Evaluation publications typically summarize the results of studies to demonstrate the effectiveness of an intervention, but little is shared concerning any changes implemented during the study. We present a process evaluation protocol of a home-based gait, balance, and resistance exercise intervention to ameliorate persistent taxane-induced neuropathy study according to 7 key elements of process evaluation.
    METHODS: The process evaluation is conducted parallel to the longitudinal, randomized control clinical trial examining the effects of the home-based gait, balance, and resistance exercise program for women with persistent peripheral neuropathy following treatment with taxanes for breast cancer (IRB approval: Pro00040035). The flowcharts clarify how the intervention should be implemented in comparable settings, fidelity procedures help to ensure the participants are comfortable and identify their individual needs, and the process evaluation allows for the individual attention tailoring and focus of the research to avoid protocol deviation.
    CONCLUSIONS: The publication of the evaluation protocol plan adds transparency to the findings of clinical trials and favors process replication in future studies. The process evaluation enables the team to systematically register information and procedures applied during recruitment and factors that impact the implementation of the intervention, thereby allowing proactive approaches to prevent deviations from the protocol. When tracking an intervention continuously, positive or negative intervention effects are revealed early on in the study, giving valuable insight into inconsistent results. Furthermore, a process evaluation adds a participant-centered element to the research protocols, which allows a patient-centered approach to be applied to data collection.
    BACKGROUND: ClinicalTrials.gov NCT04621721, November 9, 2020, registered prospectively.
    METHODS: April 27, 2020, v2.
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  • 文章类型: Journal Article
    背景:阻塞性睡眠呼吸暂停/低通气综合征(OSAHS)是一种普遍存在的疾病,影响了全球相当大一部分人口,在过去的20年里,它的患病率越来越高。OSAHS的特点是睡眠期间反复上呼吸道(UA)闭合,导致对生活质量产生重大影响,并增加心血管和代谢发病率。尽管持续气道正压通气(CPAP)是治疗的金标准,由于各种因素,患者的依从性仍然欠佳,如不适,副作用,和治疗不可接受。
    目的:考虑到与CPAP依从性相关的挑战,我们探索了一种通过肌功能疗法靶向UA肌肉的替代方法.这种非侵入性干预涉及嘴唇的锻炼,舌头,或两者都可以改善口咽功能并减轻OSAHS的严重程度。为了开发用于基于家庭的肌功能治疗的便携式设备,并连续监测运动表现和依从性,本研究的主要结局是完成和坚持4周训练的程度.
    方法:这项概念验证研究的重点是一种便携式设备,该设备旨在促进舌头和嘴唇的肌功能治疗,并能够精确监测运动表现和依从性。进行了一项临床研究,以评估该计划在改善睡眠呼吸障碍方面的有效性。参与者被指示进行舌头突出,唇压,控制呼吸作为各种任务的一部分,每周6次,持续4周,每节持续约35分钟。
    结果:10名参与者被纳入研究(n=8名男性;平均年龄48岁,SD22岁;平均BMI29.3,SD3.5kg/m2;平均呼吸暂停低通气指数[AHI]20.7,SD17.8/小时)。在完成为期4周的计划的8名参与者中,总体依从率为91%(175/192次).对于舌头运动,成功率从第一天的66%(211/320练习;SD18%)增加到最后一天的85%(272/320练习;SD17%)(P=0.05)。训练结束后AHI没有明显变化,但成功的嘴唇运动改善与仰卧位AHI降低之间存在显著相关性(Rs=-0.76;P=0.03)。这些发现证明了该设备在肌功能治疗期间准确监测参与者在嘴唇和舌头压力练习中的表现的潜力。训练计划的多样性(it混合练习混合训练游戏),它能够为每个练习向参与者提供直接反馈,和治疗依从性的容易测量是我们的培训计划的主要优势。
    结论:该研究的便携式家用肌功能疗法设备有望作为降低OSAHS严重程度的非侵入性替代方法,成功的嘴唇锻炼改善与AHI减少之间存在显着相关性,保证进一步的发展和调查。
    BACKGROUND: Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a prevalent condition affecting a substantial portion of the global population, with its prevalence increasing over the past 2 decades. OSAHS is characterized by recurrent upper airway (UA) closure during sleep, leading to significant impacts on quality of life and heightened cardiovascular and metabolic morbidity. Despite continuous positive airway pressure (CPAP) being the gold standard treatment, patient adherence remains suboptimal due to various factors, such as discomfort, side effects, and treatment unacceptability.
    OBJECTIVE: Considering the challenges associated with CPAP adherence, an alternative approach targeting the UA muscles through myofunctional therapy was explored. This noninvasive intervention involves exercises of the lips, tongue, or both to improve oropharyngeal functions and mitigate the severity of OSAHS. With the goal of developing a portable device for home-based myofunctional therapy with continuous monitoring of exercise performance and adherence, the primary outcome of this study was the degree of completion and adherence to a 4-week training session.
    METHODS: This proof-of-concept study focused on a portable device that was designed to facilitate tongue and lip myofunctional therapy and enable precise monitoring of exercise performance and adherence. A clinical study was conducted to assess the effectiveness of this program in improving sleep-disordered breathing. Participants were instructed to perform tongue protrusion, lip pressure, and controlled breathing as part of various tasks 6 times a week for 4 weeks, with each session lasting approximately 35 minutes.
    RESULTS: Ten participants were enrolled in the study (n=8 male; mean age 48, SD 22 years; mean BMI 29.3, SD 3.5 kg/m2; mean apnea-hypopnea index [AHI] 20.7, SD 17.8/hour). Among the 8 participants who completed the 4-week program, the overall compliance rate was 91% (175/192 sessions). For the tongue exercise, the success rate increased from 66% (211/320 exercises; SD 18%) on the first day to 85% (272/320 exercises; SD 17%) on the last day (P=.05). AHI did not change significantly after completion of training but a noteworthy correlation between successful lip exercise improvement and AHI reduction in the supine position was observed (Rs=-0.76; P=.03). These findings demonstrate the potential of the device for accurately monitoring participants\' performance in lip and tongue pressure exercises during myofunctional therapy. The diversity of the training program (it mixed exercises mixed training games), its ability to provide direct feedback for each exercise to the participants, and the easy measurement of treatment adherence are major strengths of our training program.
    CONCLUSIONS: The study\'s portable device for home-based myofunctional therapy shows promise as a noninvasive alternative for reducing the severity of OSAHS, with a notable correlation between successful lip exercise improvement and AHI reduction, warranting further development and investigation.
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