digital health application

数字健康应用
  • 文章类型: Journal Article
    在这项试点研究中,作者调查了数字生活方式干预的初步有效性,actensio(mementorDEGmbH),治疗动脉高血压。患有动脉高血压的成年人以1:1的比例随机分配到干预组(actensio标准护理)或对照组(等待名单标准护理)。在基线(t0)和随机化后3个月(t1)评估主要和次要终点。主要终点是平均收缩压,在家测量1周。次要终点包括患者参与(使用“患者激活测量”;PAM-13测量),平均舒张压,和心率。使用ANCOVA模型分析所有终点,遵循意向治疗方法,同时调整基线值。使用多个插补模型估计缺失数据。总共N=102名参与者(f=59,年龄=52.94±9.01)被随机分为干预组(IG;N=52)或对照组(CG;N=50),其中N=80完成了血压日记,和N=81的PAM-13在t1。组间比较显示,干预组(M=137.37±10.13)和对照组(M=142.35±11.23)之间收缩压的平均组间差异为-5.06mmHg(95%CI=-8.71至-1.41,p=.013)。患者参与的平均组差异为3.35分,具有统计学意义的趋势(95%CI=-018至6.89,p=.064),有利于干预组(MIG=79.38±9.44vs.MCG=75.45±10.62)。舒张压(-1.78mmHg;95%CI=-4.50至0.95,p=.402)和心率(-0.684;95%CI=-3.73至2.36,p=0.683)没有组间差异。本试点研究的结果证实了数字生活方式干预的初步有效性,actensio,降低高血压患者的高血压。
    In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the \"patient activation measure\"; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of N = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; N = 52) or the control group (CG; N = 50), of which N = 80 completed the blood pressure diary, and N = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of -5.06 mm Hg (95% CI = -8.71 to -1.41, p = .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = -018 to 6.89, p = .064), favoring the intervention group (MIG = 79.38 ± 9.44 vs. MCG = 75.45 ± 10.62). There were no group differences in diastolic blood pressure (-1.78 mm Hg; 95% CI = -4.50 to 0.95, p = .402) and heart rate (-0.684; 95% CI = -3.73 to 2.36, p = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.
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  • 文章类型: Journal Article
    新兴的数字技术有望改善乳腺癌护理,然而,临床医生缺乏意识往往会阻碍及时采用。本研究旨在调查乳腺癌医疗保健专业人员(HCP)对三种技术的当前认识和使用意向:(1)数字健康应用(DHA),(2)人工智能(AI),和(3)区块链技术(BC)。在30分钟的教育演示之前和之后,设计并实施了22个项目的问卷,重点介绍了技术实施示例。使用7点Likert量表测量技术意识和使用意向。人口统计学之间的相关性,技术意识,使用意向,和电子健康素养(GR-eHEALS量表)进行分析。45名HCP完成了问卷,其中26人(57.8%)为女性。年龄范围从24到67{平均年龄(SD):44.93±12.62}。DHA的知晓率最高(68.9%),其次是AI(66.7%)和BC(24.4%)。呈现导致使用意向AI{5.37(±1.81)至5.83(±1.64)}的非显著增加。出现后HCP的意向使用BC显著增加{4.30(±2.04)至5.90(±1.67),p<0.01}。GR-eHEALS的平均累积得分平均为33.04(±6.61)。HCP对AI的预期使用与电子健康素养显着相关(ρ=0.383;p<0.01),使用意向BC(ρ=0.591;p<0.01)和参与者年龄(ρ=-0.438;p<0.01)。这项研究表明,即使是简短的实际演示也会对HCP使用新兴数字技术的意图产生影响。培训潜在的专业用户应与新信息技术的发展同时解决,对于提高HCP的相应意识和预期用途至关重要。
    Emerging digital technologies promise to improve breast cancer care, however lack of awareness among clinicians often prevents timely adoption. This study aims to investigate current awareness and intention-to-use of three technologies among breast cancer healthcare professionals (HCP): (1) digital health applications (DHA), (2) artificial intelligence (AI), and (3) blockchain technology (BC). A 22-item questionnaire was designed and administered before and after a 30 min educational presentation highlighting technology implementation examples. Technology awareness and intention-to-use were measured using 7-point Likert scales. Correlations between demographics, technology awareness, intention-to-use, and eHealth literacy (GR-eHEALS scale) were analyzed. 45 HCP completed the questionnaire, of whom 26 (57.8%) were female. Age ranged from 24 to 67 {mean age (SD): 44.93 ± 12.62}. Awareness was highest for DHA (68.9%) followed by AI (66.7%) and BC (24.4%). The presentation led to a non-significant increase of intention-to-use AI {5.37 (±1.81) to 5.83 (±1.64)}. HCPs´ intention-to-use BC after the presentation increased significantly {4.30 (±2.04) to 5.90 (±1.67), p < 0.01}. Mean accumulated score for GR-eHEALS averaged 33.04 (± 6.61). HCPs´ intended use of AI significantly correlated with eHealth literacy (ρ = 0.383; p < 0.01), intention-to-use BC (ρ = 0.591; p < 0.01) and participants´ age (ρ = -0.438; p < 0.01). This study demonstrates the effect that even a short practical presentation can have on HCPs´ intention-to-use emerging digital technologies. Training potential professional users should be addressed alongside the development of new information technologies and is crucial to increase HCPs´ corresponding awareness and intended use.
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  • 文章类型: Journal Article
    背景:当前活动跟踪器中的运动确定软件的准确性不足以用于科学应用,它们也不是开源的。
    目标:为了解决这个问题,我们开发了一种精确的,可训练,以及基于智能手机的开源活动跟踪工具箱,该工具箱由一个Android应用程序(HumanActivityRecorder)和2种可以适应新行为的不同深度学习算法组成。
    方法:我们采用了一种半监督深度学习方法,基于加速度测量和陀螺仪数据来识别不同类别的活动。使用我们自己的数据和开放的竞争数据。
    结果:我们的方法对采样率和传感器尺寸输入的变化具有鲁棒性,在对我们自己记录的数据和MotionSense数据的6种不同行为进行分类时,准确率约为87%。然而,如果在我们自己的数据上测试维度自适应神经架构模型,准确率下降到26%,这证明了我们算法的优越性,它对用于训练维度自适应神经架构模型的MotionSense数据的执行率为63%。
    结论:HumanActivityRecorder是一种多功能,可重新训练,开源,和精确的工具箱,不断测试新的数据。这使研究人员能够适应被测量的行为,并在科学研究中实现可重复性。
    BACKGROUND: The accuracy of movement determination software in current activity trackers is insufficient for scientific applications, which are also not open-source.
    OBJECTIVE: To address this issue, we developed an accurate, trainable, and open-source smartphone-based activity-tracking toolbox that consists of an Android app (HumanActivityRecorder) and 2 different deep learning algorithms that can be adapted to new behaviors.
    METHODS: We employed a semisupervised deep learning approach to identify the different classes of activity based on accelerometry and gyroscope data, using both our own data and open competition data.
    RESULTS: Our approach is robust against variation in sampling rate and sensor dimensional input and achieved an accuracy of around 87% in classifying 6 different behaviors on both our own recorded data and the MotionSense data. However, if the dimension-adaptive neural architecture model is tested on our own data, the accuracy drops to 26%, which demonstrates the superiority of our algorithm, which performs at 63% on the MotionSense data used to train the dimension-adaptive neural architecture model.
    CONCLUSIONS: HumanActivityRecorder is a versatile, retrainable, open-source, and accurate toolbox that is continually tested on new data. This enables researchers to adapt to the behavior being measured and achieve repeatability in scientific studies.
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  • 文章类型: Systematic Review
    近年来,mHealth应用程序的数量迅速增加。文献表明,采用mHealth应用程序存在许多问题和障碍,包括有效性等问题,可用性,以及数据隐私和安全。持续的质量评估和保证体系可能有助于克服这些障碍。这次范围审查的目的是整理有关mHealth应用程序的质量评估工具和质量保证体系的文献,编译工具的组件,并得出总体质量尺寸,这可能与mHealth应用程序的持续质量评估相关。
    文献检索在Medline进行,EMBASE和PsycInfo。包括英语或德语的文章,如果它们包含有关发展的信息,应用程序,或验证mHealth应用程序的质量评估或质量保证的通用概念。筛选和提取由两名研究人员独立进行。提取确定的质量标准和方面,并将其聚类为质量维度。
    共有70种出版物符合纳入标准。包含的出版物包含有关五个质量保证系统的信息,以及用于mHealth应用程序的24个质量评估工具。在这29个系统/工具中,开发了8个用于评估特定疾病的mHealth应用程序,16个用于评估所有健康领域的mHealth应用程序,另外5个不限于健康应用程序。提取确定的质量标准和方面,并将其分为总共14个质量维度,即“信息和透明度”,“有效性和(添加)值”,“(医疗)安全”,“互操作性和兼容性”,\"实际\",\"订婚\",“数据隐私和数据安全”,“可用性和设计”,\"技术\",“组织方面”,“社会方面”,“法律方面”,“公平与平等”,和“成本(-有效性)”。
    此范围审查提供了对现有质量评估和保证体系的广泛概述。所包含的许多工具仅涵盖几个方面和方面,因此无法进行全面的质量评估或质量保证。我们的发现可以为mHealth应用程序的持续质量评估和保证系统的开发做出贡献。
    https://www.researchprotocols.org/2022/7/e36974/,国际注册报告标识符,IRRID(DERR1-10.2196/36974)。
    UNASSIGNED: The number of mHealth apps has increased rapidly during recent years. Literature suggests a number of problems and barriers to the adoption of mHealth apps, including issues such as validity, usability, as well as data privacy and security. Continuous quality assessment and assurance systems might help to overcome these barriers. Aim of this scoping review was to collate literature on quality assessment tools and quality assurance systems for mHealth apps, compile the components of the tools, and derive overarching quality dimensions, which are potentially relevant for the continuous quality assessment of mHealth apps.
    UNASSIGNED: Literature searches were performed in Medline, EMBASE and PsycInfo. Articles in English or German language were included if they contained information on development, application, or validation of generic concepts of quality assessment or quality assurance of mHealth apps. Screening and extraction were carried out by two researchers independently. Identified quality criteria and aspects were extracted and clustered into quality dimensions.
    UNASSIGNED: A total of 70 publications met inclusion criteria. Included publications contain information on five quality assurance systems and further 24 quality assessment tools for mHealth apps. Of these 29 systems/tools, 8 were developed for the assessment of mHealth apps for specific diseases, 16 for assessing mHealth apps for all fields of health and another five are not restricted to health apps. Identified quality criteria and aspects were extracted and grouped into a total of 14 quality dimensions, namely \"information and transparency\", \"validity and (added) value\", \"(medical) safety\", \"interoperability and compatibility\", \"actuality\", \"engagement\", \"data privacy and data security\", \"usability and design\", \"technology\", \"organizational aspects\", \"social aspects\", \"legal aspects\", \"equity and equality\", and \"cost(-effectiveness)\".
    UNASSIGNED: This scoping review provides a broad overview of existing quality assessment and assurance systems. Many of the tools included cover only a few dimensions and aspects and therefore do not allow for a comprehensive quality assessment or quality assurance. Our findings can contribute to the development of continuous quality assessment and assurance systems for mHealth apps.
    UNASSIGNED: https://www.researchprotocols.org/2022/7/e36974/, International Registered Report Identifier, IRRID (DERR1-10.2196/36974).
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  • 文章类型: Published Erratum
    [这更正了文章DOI:10.3389/frhs.2024.1372522。].
    [This corrects the article DOI: 10.3389/frhs.2024.1372522.].
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  • 文章类型: Journal Article
    自2019年以来,在德国法定健康保险中投保的人有权使用名为DigitaleGesundheitsanwendungen[数字健康应用程序(DiGA)]的认证应用程序。这样做的前提是存在一个经过DiGA认证并适合其诊断的应用程序。然后,DiGA可以由医生或心理治疗师开处方,也可以由患者从法定健康保险基金中提出要求。鉴于这种医疗保健的新颖性,应密切监测DiGA的实施,以确定潜在的弱点并实现质量改进。为了能够逐步分析DiGA的供应,我们的目标是创建DiGA-Care路径。
    我们进行了三个步骤来创建DiGA-Care路径。首先,基于结构化的文献研究创建了一个知识库,该知识库与德国联邦联合委员会资助的上级研究项目“QuaSiApps”中收集的知识相匹配。第二,我们的目标是使用流程图创建一个“理想-典型”的DiGA-Care路径。第三,基于第一条路径,使用图形建模语言“事件驱动过程链”开发了最终路径。\"
    开发DiGA-CarePath是为了描述德国DiGA的供应。最终路径由“主路径”和相应的“子路径”构成。虽然“主要路径”更侧重于使用DiGA的供应环境,“子路径”描述了DiGA本身交付的供应。除了过程本身,这些路径包括相关参与者,以指示各个流程步骤的责任。
    DiGA-CarePath有助于逐步分析DiGA的电流供应。因此,每个步骤都可以详细调查,以识别问题并检测可以实现质量改进的进一步步骤。根据视角,要么专注于供应环境,或DiGA本身提供的供应,可以使用“主路径”或“子路径”,分别。除了DiGA-Care路径改善DiGA当前供应的潜力外,它可以帮助国际政策制定者或其他利益相关者开发自己的应用程序到医疗保健系统或国际制造商考虑进入德国市场的方向。
    UNASSIGNED: Since 2019 people who have insured in the German statutory health insurance are entitled to use certified apps called the Digitale Gesundheitsanwendungen [Digital Health Applications (DiGAs)]. The prerequisite for this is that an app certified as DiGA and suitable for their diagnosis exists. The DiGA can then either be prescribed by a physician or psychotherapist or requested by the patient from the statutory health insurance fund. Given the novelty of this type of healthcare, the implementation of a DiGA should be closely monitored to identify potential weaknesses and achieve quality improvements. To enable an analysis of the supply of DiGAs step-by-step, we aimed to create the DiGA-Care Path.
    UNASSIGNED: We conducted three steps to create the DiGA-Care Path. First, a knowledge base was created based on a structured literature research matched with knowledge gathered from the superordinate research project \"QuaSiApps\" funded by the German Federal Joint Committee. Second, we aimed to create an \"ideal-typical\" DiGA-Care Path using a flowchart. Third, based on the first path, a final path was developed using the graphical modeling language \"Event-Driven Process Chain.\"
    UNASSIGNED: The DiGA-Care Path was developed to depict the supply of DiGAs in Germany. The final path is constituted by a \"main path\" as well as a corresponding \"sub-path\". While the \"main path\" focuses more on the supply environment in which a DiGA is used, the \"sub-path\" depicts the supply delivered by the DiGA itself. Besides the process itself, the paths include relevant actors to indicate responsibilities for individual process steps.
    UNASSIGNED: The DiGA-Care Path helps to analyze the current supply of DiGAs step-by-step. Thereby, each step can be investigated in detail to identify problems and to detect further steps where quality improvements can be enabled. Depending on the perspective, focused either on the supply environment, or the supply delivered by the DiGA itself, the \"main path\" or the \"sub-path\" can be used, respectively. Besides the potential of the DiGA-Care Path to improve the current supply of DiGAs, it can help as an orientation for international policymakers or further stakeholders either to develop their own integration of apps into healthcare systems or for international manufacturers to consider entering the German market.
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  • 文章类型: Journal Article
    在一项随机对照试验中,评估了数字糖尿病日记在减少糖尿病困扰方面的疗效.
    一项为期12周随访的随机对照试验在德国41个研究中心进行。关键的合格标准是诊断为1型,2型或妊娠期糖尿病,并定期自我监测血糖。参与者被随机分配(2:1比例)使用数字糖尿病日志(mySugrPRO),或不使用应用程序的控制组。主要结果是12周随访时糖尿病困扰的减少。所有分析均基于所有随机参与者的意向治疗人群。该试验在德国临床研究注册中心(DRKS00022923)注册。
    在2021年2月11日至2022年6月24日之间,424名参与者(50%为女性,包括50%的男性),282人被随机分配到干预组(66.5%),142人被随机分配到对照组(33.5%)。共有397名参与者完成了试验(辍学率:6.4%)。干预组糖尿病困扰的中位数减少为2.41(四分位距[IQR]:-2.50至8.11),对照组为1.25(IQR:-5.00至7.50)。基于模型的校正组间差异显著(-2.20,IQR:-4.02至-0.38,P=.0182)有利于干预组。有27个不良事件,干预组17人(6.0%),对照组10例(7.0%)。
    数字糖尿病日志在改善1型、2型和妊娠糖尿病患者心理健康方面的功效得到了证明。
    UNASSIGNED: In a randomized controlled trial, the efficacy of a digital diabetes diary regarding a reduction of diabetes distress was evaluated.
    UNASSIGNED: A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923).
    UNASSIGNED: Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: -2.50 to 8.11) in the intervention group and 1.25 (IQR: -5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (-2.20, IQR: -4.02 to -0.38, P = .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group.
    UNASSIGNED: The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.
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  • 文章类型: Journal Article
    季节性流感的流行是中国主要的公共卫生问题。来自CDC的流感样疾病的历史百分比(ILI%)和来自健康相关应用程序的健康查询数据被收集。将实时ILI相关搜索查询与一周前的ILI%组合时,它能够正确和及时地预测ILI的趋势。数字健康应用正在成为中国传统流感监测系统的补充。
    Epidemics of seasonal influenza is a major public health concern in china. Historical percentage of influenza-like illness (ILI%) from CDC and health enquiry data from a health-related application were collected, when combining the real-time ILI-related search queries with one-week ago\'s ILI%, it was able to predict the trend of ILI correctly and timely. Digital health application is potentializing a supplement to the traditional influenza surveillance systems in China.
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  • 文章类型: Journal Article
    背景:移动eHealth应用程序已被用作补充治疗,以提高患者的生活质量,并为风湿性疾病的管理提供新的机会。远程医疗,特别是在预防领域,诊断,和治疗,已成为风湿性疾病患者护理的重要基石。
    目的:本研究旨在改进YogiTherapy的设计和技术,并评估其可用性和质量。
    方法:我们以现代设计新实施了移动eHealth应用程序YogiTherapy,更改语言的选项,和轻松导航,以提高应用程序的可用性和质量为患者。细化后,我们通过对16例AS患者(4例女性,12例男性;平均年龄48.1,SD16.8岁)进行研究,对应用进行了评估.我们通过具有思考协议的任务性能测试(TPT)和德语版移动应用程序评定量表(MARS)评估了YogiTherapy的可用性。
    结果:在TPT中,参与者必须解决应该在应用程序上执行的6个任务。TPT中的整体任务完成率较高(84/96,88%完成任务)。过滤视频并导航以执行评估测试在TPT期间导致了最大的问题,在应用程序中注册和观看瑜伽视频时非常直观。此外,16名参与者中有12名(75%)完成了德语版的MARS。YogiTherapy的质量从最高得分为5,平均MARS得分为3.79(SD0.51)。此外,MARS问卷的结果显示,对功能性和美观性的评价是积极的.
    结论:经过完善和测试的YogiTherapy应用程序在大多数参与者中显示了有希望的结果。在未来,该应用程序可以作为AS患者的补充治疗。为此,仍需对更多患者进行调查.作为一个实质性的进步,我们使应用程序免费和开放的iOS应用程序和谷歌播放商店。
    BACKGROUND: Mobile eHealth apps have been used as a complementary treatment to increase the quality of life of patients and provide new opportunities for the management of rheumatic diseases. Telemedicine, particularly in the areas of prevention, diagnostics, and therapy, has become an essential cornerstone in the care of patients with rheumatic diseases.
    OBJECTIVE: This study aims to improve the design and technology of YogiTherapy and evaluate its usability and quality.
    METHODS: We newly implemented the mobile eHealth app YogiTherapy with a modern design, the option to change language, and easy navigation to improve the app\'s usability and quality for patients. After refinement, we evaluated the app by conducting a study with 16 patients with AS (4 female and 12 male; mean age 48.1, SD 16.8 y). We assessed the usability of YogiTherapy with a task performance test (TPT) with a think-aloud protocol and the quality with the German version of the Mobile App Rating Scale (MARS).
    RESULTS: In the TPT, the participants had to solve 6 tasks that should be performed on the app. The overall task completion rate in the TPT was high (84/96, 88% completed tasks). Filtering for videos and navigating to perform an assessment test caused the largest issues during the TPT, while registering in the app and watching a yoga video were highly intuitive. Additionally, 12 (75%) of the 16 participants completed the German version of MARS. The quality of YogiTherapy was rated with an average MARS score of 3.79 (SD 0.51) from a maximum score of 5. Furthermore, results from the MARS questionnaire demonstrated a positive evaluation regarding functionality and aesthetics.
    CONCLUSIONS: The refined and tested YogiTherapy app showed promising results among most participants. In the future, the app could serve its function as a complementary treatment for patients with AS. For this purpose, surveys with a larger number of patients should still be conducted. As a substantial advancement, we made the app free and openly available on the iOS App and Google Play stores.
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  • 文章类型: Journal Article
    背景:许多多发性硬化症(pwMS)患者希望了解健康行为如何变化(例如,饮食调整,身体活动,改善压力管理)可能有助于他们控制疾病。先前的研究表明,某些健康行为的改变可以改善生活质量(QoL),疲劳和其他MS结果。数字健康应用程序可能非常适合提供相关的健康行为干预措施,因为它们具有可访问性和灵活性。数字健康应用程序“levidex”旨在通过向pwMS提供基于证据的患者信息和认知行为治疗技术来促进健康行为改变。通过这样做,levidex旨在改善QoL和MS症状,如疲劳和心理健康。
    目的:先前的研究报道了levidex的发展;这项非随机试点研究检查了levidex在中度至重度残疾的pwMS中的可行性(实用性和可接受性)。此外,干预对赋权的影响,压力管理,和相关的健康行为(例如,饮食行为,身体活动)进行了探索。
    方法:levidex最初是在诊断后的第一年为新诊断的pwMS开发的,并最终进行了修改,以提供中度至重度残疾的pwMS。扩展残疾状态量表在3.5至7.5之间且疾病持续时间超过一年的参与者(n=43)有资格参加。干预在六个月的时间内使用,测量时间点在基线,3月和6月。
    结果:在完成6个月干预期的38名参与者中,18个(47.4%)完成了所有16个模块,9个(23.7%)达到了13-16个模块,这是levidex的长期维护部分。参与者在实用性和可接受性方面对levidex给予了积极评价,并且只有很少的批评意见,例如包括更多适合患有严重障碍的参与者的体育锻炼常规建议。次要终点数据显示无显著变化。
    结论:这项初步研究为levidex的实用性和可接受性提供了证据,一种数字健康应用程序,旨在促进中度至重度残疾的pwMS的健康行为改变。需要具有较长随访期的足够动力的随机对照研究,以阐明levidex在中度至重度残疾的pwMS中的益处。
    背景:德国临床试验注册(DRKS)DRKS00032667(14/09/2023);回顾性注册。
    BACKGROUND: Many persons with multiple sclerosis (pwMS) desire to learn how health behaviour changes (e.g., dietary adjustments, physical activity, improvements in stress management) might help them manage their disease. Previous research has shown that certain health behaviour changes can improve quality of life (QoL), fatigue and other MS outcomes. Digital health applications may be well suited to deliver relevant health behavioural interventions because of their accessibility and flexibility. The digital health application \"levidex\" was designed to facilitate health behaviour change by offering evidence-based patient information and cognitive-behavioural therapy techniques to pwMS. By doing so, levidex aims to improve QoL and MS symptoms such as fatigue and mental health.
    OBJECTIVE: A previous study reported on the development of levidex; this non-randomised pilot study examined the feasibility (practicability and acceptability) of levidex in pwMS with moderate to severe disability. Furthermore, the intervention\'s impact on empowerment, stress management, and relevant health behaviours (e.g., dietary behaviour, physical activity) was explored.
    METHODS: levidex was originally developed for newly diagnosed pwMS in the first year after diagnosis and eventually modified to offer access to pwMS with moderate to severe disability. Participants (n = 43) with an Expanded Disability Status Scale between 3.5 and 7.5 and a disease duration of more than one year were eligible to participate. The intervention was used over a period of six months with measurement time points at baseline, month 3 and month 6.
    RESULTS: Out of 38 participants who completed the six-month intervention period, 18 (47.4%) completed all 16 modules and 9 (23.7%) reached modules 13-16, the long-term maintenance part of levidex. Participants rated levidex positively in terms of practicability and acceptability and had only few points of criticism such as to include more physical exercise routine suggestions suitable for participants with severe impairment. Data on secondary endpoints showed no significant changes.
    CONCLUSIONS: This pilot study provided evidence for the practicability and acceptability of levidex, a digital health application designed to facilitate health behaviour change in pwMS with moderate to severe disability. Adequately powered randomised controlled studies with longer follow-up periods are needed to clarify the benefit of levidex in pwMS with moderate to severe disability.
    BACKGROUND: German Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered.
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