此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu

2026年10月9日 更新者：Helmy Sajali, MD, MPH

Development and Evaluation of CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu: A Stepped-Wedge Cluster Randomised Trial

Hand, foot and mouth disease (HFMD) is endemic in Malaysia and disproportionately affects children in childcare settings, where institutional infection prevention and control (IPC) capacity is frequently inadequate. This study develops and evaluates two linked tools: CHIPCAT (Childcare Infection Prevention Capacity Assessment Tool), which generates the Infection Prevention Capacity Index (IPCI) as an institutional capacity score, and HFMD-PREP (HFMD Prevention and Response Enhancement Programme), a structured capacity-building intervention mapped to CHIPCAT domains. Following instrument development and validation, the intervention is evaluated using a stepped-wedge cluster randomised trial (SW-CRT) across 12 licensed childcare centres in Kota Kinabalu, Sabah, Malaysia. All centres receive HFMD-PREP by the end of the study; only the timing of crossover differs by randomised sequence. The primary outcome is the change in IPCI. Secondary outcomes are staff and parent knowledge, attitude and practice (KAP) scores. HFMD incidence is analysed as an exploratory secondary disease outcome. This study is also registered with the Malaysian National Medical Research Register (NMRR ID RSCH ID-26-05258-LQ3), with parallel ethics submission to the Ministry of Health Malaysia Medical Research Ethics Committee (MOH MREC).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

780

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 马来西亚
    • Sabah
      • Kota Kinabalu、Sabah、马来西亚
        • Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Inclusion Criteria (centre level):

  • Registered/licensed childcare or ECEC centre
  • Operational for 2 years or more
  • 10 or more children enrolled
  • Located within Kota Kinabalu district

Exclusion Criteria (centre level):

  • Planned closure or relocation during the study period
  • Concurrent participation in another infection-prevention intervention
  • Home-based centre with fewer than 10 children enrolled

Inclusion Criteria (individual level - staff and parents/guardians):

  • Employed as childcare staff at, or parent/guardian of a child enrolled at, a participating centre
  • Willing and able to provide informed consent

Exclusion Criteria (individual level):

  • Unable to provide informed consent
  • Children are not individually enrolled at any stage; no child is approached, examined, interviewed, or identified as part of this study.

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Control period (usual practice)

Period during which a centre has not yet crossed over to HFMD-PREP. Centres continue existing HFMD prevention routines, including any standard MOH-recommended practices already in place; no centre is asked to discontinue existing prevention activities.
实验性的：HFMD-PREP intervention period

Period following a centre's randomised crossover step, during which the centre receives HFMD-PREP (HFMD Prevention and Response Enhancement Programme), a structured six-component digital capacity-building intervention delivered to childcare providers (Track A) and parents/guardians (Track B) via the hfmdprep.my platform, mapped to the six CHIPCAT domains.
行为的：HFMD-PREP (HFMD Prevention and Response Enhancement Programme)

A structured, six-component digital capacity-building intervention mapped to the six CHIPCAT domains (governance and policies; human resources and training; service delivery practices; supplies and physical environment; communication and engagement; sustainability and system integration), delivered through Track A (childcare providers) and Track B (parents/guardians) via the hfmdprep.my platform.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Infection Prevention Capacity Index (IPCI)
大体时间：Baseline (Week 0) and Weeks 4, 8, 12, and 16

Centre-level composite score generated by CHIPCAT (Childcare Infection Prevention Capacity Assessment Tool), calculated as the sum of item scores divided by the total maximum possible score, multiplied by 100 (range 0-100, higher scores indicate greater institutional infection prevention and control capacity). Analysed using a linear mixed-effects model with fixed effects for intervention status and time period and a random intercept for centre.
Baseline (Week 0) and Weeks 4, 8, 12, and 16

次要结果测量

结果测量
措施说明
大体时间
Staff Knowledge, Attitude and Practice (KAP) score
大体时间：Baseline (Week 0) and Weeks 4, 8, 12, and 16

Composite and subscale (knowledge, attitude, practice) scores from the Staff HFMD KAP questionnaire (Hamirudin et al., 2021), expressed as a percentage of subscale maximum. Analysed by linear mixed-effects model with random intercepts for individual nested within centre.
Baseline (Week 0) and Weeks 4, 8, 12, and 16
Parent/Guardian Knowledge, Attitude and Practice (KAP) score
大体时间：Baseline (Week 0) and Weeks 4, 8, 12, and 16

Composite and subscale (knowledge, attitude, practice) scores from the Parent/Guardian HFMD KAP questionnaire (Abd Ghani & Mansor, 2024), expressed as a percentage of subscale maximum. Analysed by linear mixed-effects model with random intercepts for individual nested within centre.
Baseline (Week 0) and Weeks 4, 8, 12, and 16
HFMD incidence (exploratory secondary outcome)
大体时间：Weeks 0 through 16 (aggregated across the 5 measurement periods)

Aggregated, centre-level HFMD case counts expressed as cases per 100 child-months, extracted from routine centre records. No individual child is enrolled or identified. AnalysWeeks 0 through 16 (aggregated across the 5 measurement periods)ed using Poisson or negative binomial models as an exploratory secondary disease outcome; the trial is not powered on this endpoint.
Weeks 0 through 16 (aggregated across the 5 measurement periods)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Helmy Sajali, MD, MPH

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年9月8日

首先提交符合 QC 标准的

2026年9月18日

首次发布 (实际的)

2026年9月24日

研究记录更新

最后更新发布 (实际的)

2026年10月13日

上次提交的符合 QC 标准的更新

2026年10月9日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CHIPCAT-HFMDPREPv.05.07.2026
  • NMRR ID-26-03135-GPA (注册表标识符：National Medical Research Register (NMRR), Malaysia)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅