CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
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).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Helmy Sajali @ Majali
- 전화번호: +601129857445
- 이메일: amiesajali@gmail.com
연구 장소
-
-
Sabah
-
Kota Kinabalu, Sabah, 말레이시아
- Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah
-
연락하다:
- Helmy Sajali @ Majali
- 전화번호: +601129857445
- 이메일: amiesajali@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 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. |
|
|
실험적: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Infection Prevention Capacity Index (IPCI)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Staff Knowledge, Attitude and Practice (KAP) score
기간: 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
기간: 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)
기간: 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)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHIPCAT-HFMDPREPv.05.07.2026
- NMRR ID-26-03135-GPA (레지스트리 식별자: National Medical Research Register (NMRR), Malaysia)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .