cluster randomized controlled trial

群集随机对照试验
  • 文章类型: Journal Article
    父母的健康素养对儿童的健康和发展很重要,尤其是头三年。然而,很少有研究探索有效的干预策略来提高父母的识字能力。
    本研究旨在确定基于微信公众号(WOA)的干预措施对0-3岁儿童主要照顾者父母健康素养的影响。
    这项集群随机对照试验招募了闵行区所有13个社区卫生中心(CHC)的1332个照顾者-儿童双子体,上海,中国,2020年4月至2021年4月。干预CHC的参与者通过WOA收到了有目的地设计的视频,自动记录每个参与者的观看时间,补充了来自其他受信任的基于网络的来源的阅读材料。视频的内容是根据WHO(世界卫生组织)/欧洲(WHO/欧洲)的全面父母健康素养模型构建的。对照CHC的参与者接受了与干预组相似的印刷材料。所有参与者均随访9个月。两组都可以在随访期间像往常一样获得常规的儿童保健服务。主要结果是通过经过验证的仪器测量的父母健康素养,中国父母健康素养问卷(CPHLQ)0-3岁儿童。次要结果包括育儿行为和儿童健康结果。我们使用广义线性混合模型(GLMM)进行数据分析,并进行了不同的亚组分析。β系数,风险比(RR),他们的95%CI用于评估干预效果。
    经过9个月的干预后,69.4%(518/746)的护理人员观看了至少1个视频。干预组患者CPHLQ总分(β=2.51,95%CI0.12~4.91)和心理评分(β=1.63,95%CI0.16~3.10)均高于对照组。干预组还报告了6个月时纯母乳喂养(EBF)的发生率更高(38.9%vs23.44%;RR1.90,95%CI1.07-3.38),并且6个月以下婴儿对维生素D补充的知晓率更高(76.7%vs70.5%;RR1.39,95%CI1.06-1.82)。对CPHLQ的身体评分没有检测到显著影响,母乳喂养率,常规检查率,和儿童的健康结果。此外,尽管干预对总CPHLQ评分和EBF率的影响有轻微的亚组差异,在这些亚组因素和干预因素之间未观察到交互作用.
    通过WOA使用基于WHO扫盲模型的健康干预措施有可能在6个月时提高父母的健康素养和EBF率。然而,需要创新的策略和基于证据的内容,以吸引更多的参与者,并实现更好的干预效果。
    UNASSIGNED: Parental health literacy is important to children\'s health and development, especially in the first 3 years. However, few studies have explored effective intervention strategies to improve parental literacy.
    UNASSIGNED: This study aimed to determine the effects of a WeChat official account (WOA)-based intervention on parental health literacy of primary caregivers of children aged 0-3 years.
    UNASSIGNED: This cluster randomized controlled trial enrolled 1332 caregiver-child dyads from all 13 community health centers (CHCs) in Minhang District, Shanghai, China, between April 2020 and April 2021. Participants in intervention CHCs received purposefully designed videos via a WOA, which automatically recorded the times of watching for each participant, supplemented with reading materials from other trusted web-based sources. The contents of the videos were constructed in accordance with the comprehensive parental health literacy model of WHO (World Health Organization)/Europe (WHO/Europe). Participants in control CHCs received printed materials similar to the intervention group. All the participants were followed up for 9 months. Both groups could access routine child health services as usual during follow-up. The primary outcome was parental health literacy measured by a validated instrument, the Chinese Parental Health Literacy Questionnaire (CPHLQ) of children aged 0-3 years. Secondary outcomes included parenting behaviors and children\'s health outcomes. We used the generalized linear mixed model (GLMM) for data analyses and performed different subgroup analyses. The β coefficient, risk ratio (RR), and their 95% CI were used to assess the intervention\'s effect.
    UNASSIGNED: After the 9-month intervention, 69.4% (518/746) of caregivers had watched at least 1 video. Participants in the intervention group had higher CPHLQ total scores (β=2.51, 95% CI 0.12-4.91) and higher psychological scores (β=1.63, 95% CI 0.16-3.10) than those in the control group. The intervention group also reported a higher rate of exclusive breastfeeding (EBF) at 6 months (38.9% vs 23.44%; RR 1.90, 95% CI 1.07-3.38) and a higher awareness rate of vitamin D supplementation for infants younger than 6 months (76.7% vs 70.5%; RR 1.39, 95% CI 1.06-1.82). No significant effects were detected for the physical score on the CPHLQ, breastfeeding rate, routine checkup rate, and children\'s health outcomes. Furthermore, despite slight subgroup differences in the intervention\'s effects on the total CPHLQ score and EBF rate, no interaction effect was observed between these subgroup factors and intervention factors.
    UNASSIGNED: Using a WHO literacy model-based health intervention through a WOA has the potential of improving parental health literacy and EBF rates at 6 months. However, innovative strategies and evidence-based content are required to engage more participants and achieve better intervention outcomes.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    目的:本研究旨在评估健康教育干预(HEI)对埃塞俄比亚南部孕产妇保健服务利用(MHSU)的影响。
    方法:从2023年1月10日至8月1日,以社区为基础,双臂,在Sidama国家区域州北部地区的孕妇中进行了平行组群随机对照试验(cRCT),埃塞俄比亚。我们利用具有稳健方差的多级混合效应修正泊松回归来控制聚类和潜在混杂因素的影响。针对多重比较调整显著性水平。
    结果:治疗组至少一次产前护理(ANC)访视的总利用率为90.2%,对照组为59.5%(χ2=89.22,p<0.001)。治疗组(74.3%)和对照组(50.8%)的医疗机构分娩(HFD)利用率有很大差异(χ2=70.50,p<0.001)。HEI显著提高了ANC利用率(调整后风险比[ARR]:1.32;99%CI:1.12-1.56)和HFD利用率(ARR:1.24;99%CI:1.06-1.46)。治疗组中至少一项产后护理(PNC)服务的利用率为65.4%,对照组为52.1%(χ2=19.51,p=0.01)。然而,在控制了混杂因素和聚类的影响后,HEI对PNC利用的影响在两组之间不显著(ARR:1.15;99%CI:0.89-1.48)。
    结论:基于社区的HEI显著提高了ANC和HFD的利用率,但没有提高PNC的利用率。用某些修饰扩展HEI将对改善MHSU具有优异的效果。
    背景:NCT05865873。
    OBJECTIVE: This study aimed to evaluate the effect of health education intervention (HEI) on maternal health service utilization (MHSU) in southern Ethiopia.
    METHODS: From 10 January to 1 August 2023, a community-based, two-arm, parallel-group cluster randomized controlled trial (cRCT) was conducted among pregnant mothers in the Northern Zone of Sidama National Regional State, Ethiopia. We utilized multilevel mixed-effects modified Poisson regression with robust variance to control for the effects of clustering and potential confounders. The level of significance was adjusted for multiple comparisons.
    RESULTS: The overall utilization of at least one antenatal care (ANC) visit was 90.2% in the treatment group and 59.5% in the comparator group (χ2 = 89.22, p < 0.001). Health facility delivery (HFD) utilization was considerably different between the treatment group (74.3%) and the comparator group (50.8%) (χ2 = 70.50, p < 0.001). HEI significantly increased ANC utilization (adjusted risk ratio [ARR]: 1.32; 99% CI: 1.12-1.56) and HFD utilization (ARR: 1.24; 99% CI: 1.06-1.46). The utilization of at least one postnatal care (PNC) service was 65.4% in the treatment group and 52.1% in the comparator group (χ2 = 19.51, p = 0.01). However, after controlling for the effects of confounders and clustering, the impact of HEI on PNC utilization was insignificant between the two groups (ARR: 1.15; 99% CI: 0.89-1.48).
    CONCLUSIONS: A community-based HEI significantly increased ANC and HFD utilization but did not increase PNC utilization. Expanding the HEI with certain modifications will have a superior effect on improving MHSU.
    BACKGROUND: NCT05865873.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:尽管护理部门在老龄化社会中越来越重要,代表未来劳动力的学生往往表现出健康不足。承认适当的身体活动对增进健康的作用,巴伐利亚的教育系统,德国,最近将促进与身体活动相关的健康能力(PAHCO)纳入护理课程。然而,不能认为PAHCO已经充分渗透了护理学校的教育实践和常规。因此,本研究的目的是研究和比较不同干预方法在巴伐利亚护理学校系统中解决PAHCO的有效性和实施情况.
    方法:我们将16所护理学校(基于集群)随机分配到四个研究组(自下而上,自上而下由教师领导,由外部体育活动专家自上而下领导,对照组)。干预组1(IG-1)中的学校通过合作计划(准备,规划,和实施阶段)。干预组2和3(IG-2,IG-3)通过经过训练的调解员接受基于专家的干预(通过干预映射开发),以解决PAHCO问题。外部体育活动专家在IG-2中提供结构化的PAHCO干预,而护士学校的老师自己在IG-3中进行PAHCO干预。根据混合有效性实施试验,我们在所有条件下应用基于问卷的事前测量(样本量计算:nfinal=636),以检查干预方法的有效性,同时,利用问卷,采访,和协议数据来检查它们的实现。我们通过线性模型(时间-群体相互作用)分析定量有效性数据,和使用描述性分布和内容分析的实施数据。
    结论:该研究能够基于证据决定三种干预方法的适用性,以促进健康,护理学生的身体活跃的生活方式。调查结果为传播活动提供了信息,以有效地覆盖巴伐利亚护理系统的所有185所学校。
    背景:临床试验NCT05817396。2023年4月18日注册。
    BACKGROUND: Although the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physical activity, the educational system in Bavaria, Germany, has recently integrated the promotion of physical activity-related health competence (PAHCO) into the nursing curriculum. However, it cannot be assumed that PAHCO has sufficiently permeated the educational practices and routines of the nursing schools. Therefore, the goal of the present study is to examine and compare the effectiveness as well as implementation of different intervention approaches to address PAHCO in the Bavarian nursing school system.
    METHODS: We randomly assign 16 nursing schools (cluster-based) to four study arms (bottom-up, top-down led by teachers, top down led by external physical activity experts, control group). Schools in intervention group 1 (IG-1) develop multicomponent inventions to target PAHCO via cooperative planning (preparation, planning, and implementation phase). Intervention groups 2 and 3 (IG-2, IG-3) receive both an expert-based intervention (developed through intervention mapping) via trained mediators to address PAHCO. External physical activity experts deliver the structured PAHCO intervention in IG-2, while teachers from the nursing schools themselves conduct the PAHCO intervention in IG-3. In line with a hybrid effectiveness implementation trial, we apply questionnaire-based pre-post measurements across all conditions (sample size calculation: nfinal = 636) to examine the effectiveness of the intervention approaches and, simultaneously, draw on questionnaires, interview, and protocol data to examine their implementation. We analyze quantitative effectiveness data via linear models (times-group interaction), and implementation data using descriptive distributions and content analyses.
    CONCLUSIONS: The study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system.
    BACKGROUND: Clinical trials NCT05817396. Registered on April 18, 2023.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Preprint
    背景肺癌筛查(LCS)可以降低肺癌死亡率,但对患者有潜在的危害。医疗保险和医疗补助服务中心(CMS)需要就LCS进行共享决策(SDM)对话,以报销LCS。为了克服初级保健中SDM的障碍,该协议描述了由患者导航员提供的针对初级保健诊所LCS的远程医疗决策指导干预.该研究的目的是评估干预措施的有效性及其实施潜力,与增强的常规护理(EUC)臂相比。方法将初级保健临床医生(n=120)的患者(n=420)招募到整群随机对照试验中。临床医生被随机分配到1)TELESCOPE干预:在即将到来的非急性临床就诊之前,患者参加由训练有素的患者导航员和护士导航员提供的关于LCS的远程健康决策指导会议,为每位想要LCS的TELESCOPE患者安排低剂量CT扫描(LDCT)订单,或2)EUC:患者接受临床医生的强化常规护理。通过为双方的临床医生提供有关LCS的继续医学教育(CME)网络研讨会和LCS讨论指南,可以增强日常护理。患者在基线和预定的临床访问后1周完成调查,以评估SDM过程的质量。尝试对未在3个月内完成LDCT的TELESCOPE患者进行重新导航。在年度筛查前一个月,初次LCS显示低风险发现的TELESCOPE患者被随机分配到使用导航仪或无助推器的远程医疗决策指导助推器会话。在初始决策指导会议(TELESCOPE)或临床访问(EUC)后的6、12和18个月提取电子健康记录,以评估初始和年度LCS摄取。成像结果,异常发现的后续测试,癌症诊断,治疗,和烟草治疗推荐。本研究将使用混合方法评估促进或干扰程序实施的因素。讨论我们将评估决策指导和患者导航干预是否可以合理地支持LCS的高质量SDM和为服务于不同患者人群的繁忙初级保健实践中的患者提供指南一致的LCS摄取。试验注册:本研究于2022年8月4日在ClinicalTrials.gov(NCT05491213)注册。
    UNASSIGNED: Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm.
    UNASSIGNED: Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods.
    UNASSIGNED: We will assess whether a decision coaching and patient navigation intervention can feasibly support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations.
    UNASSIGNED: This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    暂无摘要。
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    需要有效和可持续的战略来解决资源有限的环境中五岁以下儿童可预防死亡的负担。儿童疾病综合管理工具(TIMCI)项目旨在支持医疗保健提供者识别和管理严重疾病。在促进资源管理的同时,通过将脉搏血氧饱和度和临床决策支持算法(CDSA)引入印度的初级保健机构,肯尼亚,塞内加尔和坦桑尼亚。通过以下方式评估健康影响:务实的平行小组,优势聚类随机对照试验(RCT),印度的初级保健设施随机分配(1:1)用于脉搏血氧饱和度或控制,和(1:1:1)在坦桑尼亚脉搏血氧饱和度加CDSA,脉搏血氧饱和度,或控制;并通过肯尼亚和塞内加尔的准实验性事后研究。设备的实施与指导和培训,导师,和社区参与。社会人口统计学和临床数据收集从照顾者和登记的0-59个月的患病儿童在研究机构的记录,在第7天(RCT中的第28天)进行电话随访。RCT评估的主要结果是第7天的严重并发症(死亡率和二级住院)和主要住院(24小时内和转诊);对于pre-post研究,转诊和抗生素。健康状况其他方面的次要结果,低氧血症,转介,还评估了随访和抗菌药物处方。在所有国家,嵌入式混合方法研究进一步评估干预对护理和护理过程的影响,实施,成本和成本效益。试点和基线研究将于2021年中期开始,RCT和干预后将于2022年中期开始,预计将于2023年中期完成,并于2023年后期获得首次结果。所有相关机构审查委员会已批准研究,国家和世卫组织伦理审查委员会。调查结果将与社区分享,医疗保健提供者,卫生部和其他地方,国家和国际利益攸关方,以促进扩大规模的循证决策。研究登记:NCT04910750和NCT05065320。
    脉搏血氧饱和度和临床决策支持算法显示出支持医疗保健提供者在资源有限的环境中识别和管理五岁以下初级保健儿童的严重疾病的潜力。虽然促进了资源管理,但扩大规模受到证据差距的阻碍。这篇研究设计文章描述了迄今为止对这些干预措施的最大规模评估,其结果将为国家和全球层面的政策和规划提供信息。
    Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.
    Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:在青春期使用大麻是一个公共卫生问题,必须通过预防来解决。在西班牙,青少年开始使用大麻的平均年龄为14.8岁。14岁时,大麻使用的终生患病率为11.7%,增加到51。,在18岁时占5%;14至18岁人口中使用大麻的患病率为28.6%,一个必须努力减少的数字,这就是为什么这个学校预防计划被提出:Alerta大麻。
    方法:AlertaCannabis研究项目包括设计,实施,和评价。在第一阶段,基于I-Change模型开发了计算机定制的eHealth程序(AlertaCannabis),基于三个主要行为变化过程的集成模型:意识,动机,和行动。该计划包括四个30分钟的课程,将提供文化适应和个性化的建议,以激励学生不要通过文本反馈使用大麻,动画,和游戏化技术。此阶段还将包括可用性测试。在实施阶段,来自西安达卢西亚的中学生,西班牙(塞维利亚,卡迪兹,韦尔瓦,和科尔多瓦)和东部安达卢西亚(哈恩,马拉加,和Granada)将随机分配到实验条件(EC)或对照条件(CC)进行集群随机临床试验(CRCT)。每个条件将在8所学校中有35个班级。GI将收到在线干预Alerta大麻。EC和CC必须在基线时填写问卷,六个月,和12个月的随访。在最后阶段,评估Alerta大麻的效果。主要结果是大麻使用的终生流行率及其在过去30天和6个月的使用。在12个月的随访中,还将评估过去12个月的患病率。次要结果是使用大麻的意图。
    结论:该研究测试了创新计划的效果,该计划专门旨在通过西班牙的eHealth减少青少年人群中大麻的使用。调查结果旨在制定和实施基于证据的大麻预防干预措施,这可以支持学校的预防,例如,学校护士的协助。如果该计划被证明是有效的,它可能有助于防止在国家和国际范围内使用大麻。
    背景:NCT05849636。注册日期:2023年3月16日。
    BACKGROUND: The growing use of cannabis in adolescence is a public health problem that must be addressed through prevention. In Spain, the average age of initiation of cannabis use in the adolescent population is 14.8 years. At 14 years, the lifetime prevalence of cannabis use is 11.7%, which increases to 51.,5% at the age of 18; the prevalence of cannabis use in the population aged 14 to 18 years is 28.6%, a figure that must be tried to reduce, that is why this school prevention program is proposed: Alerta Cannabis.
    METHODS: The Alerta Cannabis research project consists of design, implementation, and evaluation. In the first phase, a computer-tailored eHealth program (Alerta Cannabis) is developed based on the I-Change Model, an integrated model based on three main behavioral change processes: awareness, motivation, and action. This program consists of four 30-minute sessions that will provide culturally adapted and personalized advice to motivate students not to use cannabis through text feedback, animations, and gamification techniques. This phase will also include usability testing. In the implementation phase, secondary school students from Western Andalusia, Spain (Seville, Cádiz, Huelva, and Córdoba) and Eastern Andalusia (Jaén, Málaga, and Granada) will be randomized to an experimental condition (EC) or a control condition (CC) for a cluster randomized clinical trial (CRCT). Each condition will have 35 classes within 8 schools. GI will receive the online intervention Alerta Cannabis. EC and CC will have to fill out a questionnaire at baseline, six months, and twelve months of follow-up. In the last phase, the effect of Alerta Cannabis is evaluated. The primary outcomes are the lifetime prevalence of cannabis use and its use in the last 30 days and at 6 months. At 12 months of follow-up, the prevalence in the last 12 months will also be assessed. The secondary outcome is the intention to use cannabis.
    CONCLUSIONS: The study tests the effect of the innovative program specifically aimed to reduce the use of cannabis in the adolescent population through eHealth in Spain. The findings aim to develop and implement evidence-based cannabis prevention interventions, which could support school prevention, for instance, the assistance of school nurses. If the program proves to be effective, it could be useful to prevent cannabis use on a national and international scale.
    BACKGROUND: NCT05849636. Date of registration: March 16, 2023.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:性和性别少数群体青年(女同性恋,同性恋,双性恋,变性人,非二进制,和酷儿个体)面临使用物质的风险增加(例如,酒精和烟草)和心理健康问题(例如,抑郁症状和自杀)与他们的异性恋同伴相比。假设通过培训学校工作人员来建立支持性的高中环境,可以减少这些不平等现象。一种干预措施,可以培训学校工作人员更好地了解和支持性和性别少数群体青年,并参与积极的旁观者行为,以保护他们免受欺凌,这可能会减少他们之间在毒品和酒精使用方面的差异。专家,学校工作人员,性和性别少数群体青年发展为LGBTQ+青少年提供培养,可信性,和安全(植物),基于网络的干预,培训学校工作人员如何支持,确认,并保护性和性别少数群体青年。
    目的:本文描述了植物试验的设计,主要旨在评估其可接受性,可用性,适当性,和可行性。我们假设植物会有很高的可接受性,可用性,适当性,和可行性由学校工作人员评定。次要目标注重执行,安全,以及高中教职员工成绩的岗前变化,包括自我效能感和技能(例如,积极移情倾听和欺凌干预)。探索性目标侧重于植物对学生健康结果的影响。
    方法:在一项2臂整群随机对照试验中,马萨诸塞州的高中被分配给PLANTS或积极的比较组(公开提供性和性别少数群体青年资源或培训)。高中工作人员完成包含经过验证的量表的测试前和测试后调查。主要结果是经过验证的可接受性度量,可用性,适当性,以及工作人员在测试后调查中完成干预的可行性。为了测试我们对每个结果的主要假设,我们将使用1样本2边t检验对先验阈值或成功基准计算均值和95%CIs和P值。次要结果包括员工的积极移情倾听技巧,与性和性别少数群体青年一起工作的自我效能感,欺凌和网络欺凌的旁观者干预行为,以及在前测和后测人员调查期间完成的植物变化目标的自我效能。员工还可以在信息-动机-行为模型和实施研究综合框架的指导下完成后测访谈。探索性成果包括通过2021年和2023年MetroWest青少年健康调查收集的学生水平数据,马萨诸塞州30所学校的健康行为监测系统。
    结果:学校入学始于2023年5月,参与者入学始于2023年6月。数据收集预计将于2024年2月完成。
    结论:这项试点试验将产生有关植物干预的重要信息,并提供必要的信息,以进行充分有效的植物功效试验,以减少性和性别少数群体青年所经历的有害健康不平等。
    背景:ClinicalTrials.govNCT05897827;https://clinicaltrials.gov/study/NCT05897827。
    DERR1-10.2196/55210。
    BACKGROUND: Sexual and gender minority youths (lesbian, gay, bisexual, transgender, nonbinary, and queer individuals) face elevated risks of substance use (eg, alcohol and tobacco) and mental health issues (eg, depressive symptoms and suicidality) compared to their cisgender heterosexual peers. These inequities are hypothesized to be reduced by building supportive high school environments via the training of school staff. An intervention that trains school staff to better understand and support sexual and gender minority youths and engage in positive bystander behaviors that protect them from bullying exposure may reduce disparities in drug and alcohol use among them. Experts, school staff, and sexual and gender minority youths developed Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety (PLANTS), a web-based intervention to train school staff on how to support, affirm, and protect sexual and gender minority youths.
    OBJECTIVE: This paper describes the design of the PLANTS pilot trial primarily aimed at assessing its acceptability, usability, appropriateness, and feasibility. We hypothesize PLANTS will have high acceptability, usability, appropriateness, and feasibility as rated by the school staff. Secondary objectives focus on implementation, safety, and pre-post changes in high school staff outcomes, including self-efficacy and skills (eg, active-empathic listening and bullying intervention). Exploratory objectives focus on the impact of PLANTS on student health outcomes.
    METHODS: In a 2-arm cluster randomized controlled trial, high schools in Massachusetts are allocated to PLANTS or an active comparator group (publicly available sexual and gender minority youths resources or training). High school staff complete pretest and posttest surveys containing validated scales. Primary outcomes are validated measures of acceptability, usability, appropriateness, and feasibility of the intervention completed by staff during posttest surveys. To test our primary hypotheses for each outcome, we will calculate means and 95% CIs and P values using 1-sample 2-sided t tests against a priori thresholds or benchmarks of success. Secondary outcomes include staff\'s active-empathetic listening skills, self-efficacy for working with sexual and gender minority youths, bystander intervention behaviors for bullying and cyberbullying, and self-efficacy for PLANTS\' change objectives completed during pretest and posttest staff surveys. Staff can also complete a posttest interview guided by the Information-Motivation-Behavior model and Consolidated Framework for Implementation Research. Exploratory outcomes include student-level data collected via the 2021 and 2023 MetroWest Adolescent Health Surveys, a health behavior surveillance system in 30 Massachusetts schools.
    RESULTS: School enrollment began in May 2023 and participant enrollment began in June 2023. Data collection is expected to be completed by February 2024.
    CONCLUSIONS: This pilot trial will yield important information about the PLANTS intervention and provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the deleterious health inequities experienced by sexual and gender minority youths.
    BACKGROUND: ClinicalTrials.gov NCT05897827; https://clinicaltrials.gov/study/NCT05897827.
    UNASSIGNED: DERR1-10.2196/55210.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Clinical Trial Protocol
    背景:在未诊断和未治疗的老年人中,视力障碍和失明是常见的。主要原因是未矫正的屈光不正和白内障。视力问题与较低的生活质量有关,几个健康问题,坠落事故和骨折的可能性更高。为了消除可避免的视力障碍和失明,建议有针对性的眼科筛查计划。老年患者,接受家庭医疗保健,尚未被认为是可能从眼科筛查中受益的有风险人群。
    方法:将进行一项整群随机对照试验,以调查家庭保健中在线护士辅助眼部筛查的成本效益和成本效用,与照常护理相比,减少可避免的视力障碍。将使用医疗保健和社会观点。该研究将与荷兰的几个家庭保健组织合作进行。在线眼科筛查包括近距离和远距离视力,然后是Amsler分级测试.两组的测量将在基线以及随访6和12个月后进行。总共将招募240名参与者。老年男性和女性(65岁以上)他们接受家庭护理,并且在认知上能够参与,将包括在内。主要结果将是基线和12个月随访之间Colenbrander-1M视敏度图上的两条线或更多线的变化。
    结论:对高危人群进行眼部筛查有助于发现未确诊和未治疗的视力障碍。这可以减少视力丧失的健康相关后果和与视力损害相关的高经济负担。
    背景:ClinicalTrials.govNCT06058637。2023年9月27日注册。
    BACKGROUND: Among older people undiagnosed and untreated vision impairment and blindness are common. The leading causes are uncorrected refractive errors and cataracts. Vision problems are associated with a lower quality of life, several health problems, and a higher chance of falling accidents and fractures. To eliminate avoidable vision impairment and blindness, targeted eye screening programs are recommended. Older patients, receiving home healthcare, have not yet been considered as a population at risk who could benefit from eye screening.
    METHODS: A cluster-randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of online nurse-assisted eye screening in home healthcare, compared to care as usual, in reducing avoidable vision impairment. A healthcare and societal perspective will be used. The study will be performed in collaboration with several home healthcare organizations in the Netherlands. The online eye screening consists of near and distance visual acuity, followed by an Amsler grading test. Measurements in both groups will take place at baseline and after 6 and 12 months of follow-up. A total of 240 participants will be recruited. Older men and women (65 +), who receive home-based nursing and are cognitively able to participate, will be included. The primary outcome will be the change of two lines or more on the Colenbrander-1 M visual acuity chart between baseline and 12-month follow-up.
    CONCLUSIONS: An eye screening for populations at risk contributes to the detection of undiagnosed and untreated vision impairment. This may reduce the health-related consequences of vision loss and the high economic burden associated with vision impairment.
    BACKGROUND: ClinicalTrials.gov NCT06058637. Registered on 27 September 2023.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Clinical Trial Protocol
    背景:呼吸道病毒性疾病(RVI)-例如,流感,新冠肺炎对长期护理(LTC)设施构成严重威胁。由于居民的认知障碍,LTC设施中的标准感染控制措施并不理想,护理需求,对孤独和精神疾病的易感性。Further,患有高度虚弱的LTC居民经常会出现所谓的非典型症状(例如,谵妄,行动不便)而不是典型的咳嗽和发烧,延迟感染的诊断和治疗。尽管远UVC(222nm)光设备在体外显示出有效的抗病毒活性,临床疗效尚待证实。
    方法:在进行研究以测定每个部位的可接受性后,这个多中心,双盲,集群随机化,安慰剂对照试验旨在评估远UVC光装置是否影响LTC设施中RVIs的发生率.LTC设施内的邻居被随机化以接收远UVC光装置(222nm)或在公共区域中仅发射可见光谱光(400-700nm)的相同安慰剂光装置。使用标准筛查方案和针对非典型症状的新型筛查方案,对所有居民进行RVI监测。将使用意向治疗分析比较RVIs的3年发病率。随后将进行成本后果分析。
    结论:本试验旨在决定是否在LTC设施中实施远紫外线照明以预防RVI。试验设计特征与这一务实意图一致。已实施了适当的额外道德保护,以减轻因进行本研究而引起的参与者脆弱性。将通过媒体参与支持知识传播,同行评审的演示文稿,和出版物。
    背景:ClinicalTrials.govNCT05084898。2021年10月20日.
    BACKGROUND: Respiratory viral illness (RVI)-e.g., influenza, COVID-19-is a serious threat in long-term care (LTC) facilities. Standard infection control measures are suboptimal in LTC facilities because of residents\' cognitive impairments, care needs, and susceptibility to loneliness and mental illness. Further, LTC residents living with high degrees of frailty who contract RVIs often develop the so-called atypical symptoms (e.g., delirium, worse mobility) instead of typical cough and fever, delaying infection diagnosis and treatment. Although far-UVC (222 nm) light devices have shown potent antiviral activity in vitro, clinical efficacy remains unproven.
    METHODS: Following a study to assay acceptability at each site, this multicenter, double-blinded, cluster-randomized, placebo-controlled trial aims to assess whether far-UVC light devices impact the incidence of RVIs in LTC facilities. Neighborhoods within LTC facilities are randomized to receive far-UVC light devices (222 nm) or identical placebo light devices that emit only visible spectrum light (400-700 nm) in common areas. All residents are monitored for RVIs using both a standard screening protocol and a novel screening protocol that target atypical symptoms. The 3-year incidence of RVIs will be compared using intention-to-treat analysis. A cost-consequence analysis will follow.
    CONCLUSIONS: This trial aims to inform decisions about whether to implement far-UVC light in LTC facilities for RVI prevention. The trial design features align with this pragmatic intent. Appropriate additional ethical protections have been implemented to mitigate participant vulnerabilities that arise from conducting this study. Knowledge dissemination will be supported through media engagement, peer-reviewed presentations, and publications.
    BACKGROUND: ClinicalTrials.gov NCT05084898. October 20, 2021.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

公众号