UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049406 |
|---|---|
| Receipt number | R000056151 |
| 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. |
| Date of disclosure of the study information | 2022/11/11 |
| Last modified on | 2022/11/02 15:00:13 |
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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
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
tanaka@tsutawaru-med.com
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056151
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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