UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of awareness-raising activities through care managers regarding hepatitis C screening and treatment among elderly persons requiring support and nursing care and their families.
Acronym	Effectiveness of Hepatitis C Screening and Awareness Raising by Care Managers
Scientific Title	Effectiveness of awareness-raising activities through care managers regarding hepatitis C screening and treatment among elderly persons requiring support and nursing care and their families.
Scientific Title:Acronym	Effectiveness of Hepatitis C Screening and Awareness Raising by Care Managers
Region	Japan

Condition
Condition	Hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assuming that educating care managers about hepatitis C and providing them with materials to pass on to caregivers and family members may promote hepatitis C screening and treatment, and in order to verify this assumption, we will conduct an intervention study with the cooperation of care managers working at in-home care support facilities in Saga Prefecture, to see to what extent education about hepatitis C and educational activities by providing materials can promote screening and treatment for caregivers and family members requiring care.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	(1) Number of people who have started treatment for hepatitis C (2) Number of persons tested for hepatitis C
Key secondary outcomes	#Attendance rates for training videos #Evaluation of flyers by caregivers #Number of flyers distributed and recipients #Reaction of flyer recipients #Change in awareness of care managers as a result of this initiative

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Web-based training videos on hepatitis C and a confirmation test prior to intervention
Interventions/Control_2	No training videos or confirmation tests on hepatitis C prior to intervention
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	care managers working at in-home care support facilities in Saga Prefecture
Key exclusion criteria	Apparent discrepancies in the data reported by care managers
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hirokazu Middle name Last name Takahashi
Organization	Saga University Hospital
Division name	Liver Center
Zip code	849-0937
Address	5-1-1 Nabeshima, Saga City, Saga Prefecture
TEL	0952-34-3731
Email	takahas2@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Luna Middle name Last name Tanaka
Organization	Graduate School of Advanced Health Sciences, Saga University Master's Program
Division name	Medical Science
Zip code	849-0937
Address	5-1-1 Nabeshima, Saga City, Saga Prefecture
TEL	0952-34-3731
Homepage URL
Email	tanaka@tsutawaru-med.com

Sponsor
Institute	Saga University
Institute
Department

Funding Source
Organization	Saga University Hospital Liver Center
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	Faculty of Medicine, Saga University
Address	5-1-1 Nabeshima, Saga City, Saga Prefecture
Tel	0952-34-3318
Email	medsosou@mail.admin.saga-u.ac.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	2022 Year 11 Month 11 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	Preinitiation
Date of protocol fixation	2022 Year 08 Month 23 Day
Date of IRB	2022 Year 09 Month 28 Day
Anticipated trial start date	2022 Year 12 Month 01 Day
Last follow-up date	2023 Year 07 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	2022 Year 11 Month 02 Day
Last modified on	2022 Year 11 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056151