UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000039483 |
|---|---|
| Receipt number | R000045021 |
| Scientific Title | Eastern Uganda Hand Hygiene Multimodal Promotion Strategy and Locally-Prepared Alcohol-Based Hand Rub study: a step-wedge, cluster-randomized trial |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2021/03/20 17:35:20 |
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Basic information
Public title
Eastern Uganda Hand Hygiene Multimodal Promotion Strategy and Locally-Prepared Alcohol-Based Hand Rub study: a step-wedge, cluster-randomized trial
Acronym
MIKONO Uganda study
Scientific Title
Eastern Uganda Hand Hygiene Multimodal Promotion Strategy and Locally-Prepared Alcohol-Based Hand Rub study: a step-wedge, cluster-randomized trial
Scientific Title:Acronym
MIKONO Uganda study
Region
| Africa |
Condition
Condition
hand hygiene
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our primary objective is to evaluate the impact of the WHO hand hygiene (HH) multimodal strategy on HH compliance among HCWs at the studied health facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hand hygiene compliance at the facility level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Alcohol based hand-rub and implementation of WHO multimodal strategy to improve hand hygiene compliance
Interventions/Control_2
Alcohol based hand-rub and implementation of WHO multimodal strategy to improve hand hygiene compliance
Interventions/Control_3
Alcohol based hand-rub and implementation of WHO multimodal strategy to improve hand hygiene compliance
Interventions/Control_4
Alcohol based hand-rub and implementation of WHO multimodal strategy to improve hand hygiene compliance
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Given the nature of the intervention, which will be provided at the facility level rather than the patient level, the entire facility will be studied. The health facilities studied are 8 health facilities across 4 districts.
Key exclusion criteria
n/a
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Saito |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
241-0811
Address
1197-1 Yasashicho, Asahi-ku, Yokohama, Kanagawa, Japan
TEL
+81-45-366-1111
hiroki.saito@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Saito |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
241-0811
Address
1197-1 Yasashicho, Asahi-ku, Yokohama, Kanagawa, Japan
TEL
+81-45-366-1111
Homepage URL
hiroki.saito@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Currently, it's self-funding.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mbale Regional Referral Hospital Research & Ethics Committee (MRRH-REC)
Address
PO Box 921, Mbale, Uganda
Tel
+256-393280584
mrrhrec@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
MRRH-REC OUT COM 008C /2019
Org. issuing International ID_1
MRRH-REC
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045021
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
