Development and Evaluation of CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu: A Stepped-Wedge Cluster Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- Infection Prevention Capacity Index (IPCI)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Given the dual role of the principal investigator as both CHIPCAT assessor and HFMD-PREP deliverer, no formal masking is applied. Observation bias in CHIPCAT/IPCI scoring is mitigated through standardised scoring protocols and independent verification of 20% of assessments by a Health Officer not otherwise involved in intervention delivery.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •(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:
研究组 & 干预措施
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.
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.
干预措施: HFMD-PREP (HFMD Prevention and Response Enhancement Programme) (Behavioral)
结局指标
主要结局
Infection Prevention Capacity Index (IPCI)
时间窗: 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.
次要结局
- Staff Knowledge, Attitude and Practice (KAP) score(Baseline (Week 0) and Weeks 4, 8, 12, and 16)
- Parent/Guardian Knowledge, Attitude and Practice (KAP) score(Baseline (Week 0) and Weeks 4, 8, 12, and 16)
- HFMD incidence (exploratory secondary outcome)(Weeks 0 through 16 (aggregated across the 5 measurement periods))
研究者
Helmy Sajali, MD, MPH
DrPH Candidate
Universiti Malaysia Sabah