UMIN-CTR Clinical Trial

Basic information
Public title	Effect of an Intervention Focusing on Visualization of Hand Washing Areas for Elderly Home Care Providers: A Randomized Controlled Trial
Acronym	Effect of an Intervention Focusing on Visualization of Hand Washing Areas for Elderly Home Care Providers: A Randomized Controlled Trial
Scientific Title	Effect of an Intervention Focusing on Visualization of Hand Washing Areas for Elderly Home Care Providers: A Randomized Controlled Trial
Scientific Title:Acronym	Effect of an Intervention Focusing on Visualization of Hand Washing Areas for Elderly Home Care Providers: A Randomized Controlled Trial
Region	Japan

Condition
Condition	None
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of interventions focusing on visualization of hand washing areas for elderly home-based caregivers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hand washing areas, and awareness survey on hand hygiene
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Visualization group: In addition to standard handwashing, handwashing was focused on areas with high levels of contamination as indicated by visualization.
Interventions/Control_2	Non-visualization group: Only standard hand washing was performed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Caregivers 65 years and older
Key exclusion criteria	Caregivers under the age of 65
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Nishimura
Organization	Nanto Municipal Hospital
Division name	Department of Community-based-Rehabilitation
Zip code	932-0211
Address	938 Inami, Nanto, Toyama, Nanto, Toyama
TEL	0763-82-1475
Email	takaaki07_nishimura05@yahoo.co.jp

Public contact
Name of contact person	1st name Reiko Middle name Last name Yamada
Organization	Nanto City Home-Visit Nursing Station
Division name	Nursing Department
Zip code	932-0211
Address	938 Inami, Nanto, Toyama, Nanto, Toyama
TEL	0763-82-7775
Homepage URL
Email	yamada.reiko@city.nanto.lg.jp

Sponsor
Institute	Nanto City Home-Visit Nursing Station
Institute
Department

Funding Source
Organization	FY2021 Japan Visiting Nurse Foundation "Home Nursing and Other In-Home Care Research Grant
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nanto City Home-Visit Nursing Station
Address	938 Inami, Nanto-shi, Toyama
Tel	0763-82-7775
Email	iryoka@city.nanto.lg.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 09 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	Completed
Date of protocol fixation	2021 Year 08 Month 01 Day
Date of IRB	2021 Year 03 Month 15 Day
Anticipated trial start date	2022 Year 04 Month 30 Day
Last follow-up date	2022 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	2021 Year 07 Month 22 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051336