UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037355 |
|---|---|
| Receipt number | R000040935 |
| Scientific Title | Examination about the change of usability and the self-efficacy of the urination care support system (Lilli care) to a health visitor |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2020/07/14 17:07:41 |
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Basic information
Public title
Examination about the change of usability and the self-efficacy of the urination care support system (Lilli care) to a health visitor
Acronym
Examination about the change of usability and the self-efficacy of the urination care support system (Lilli care) to a health visitor
Scientific Title
Examination about the change of usability and the self-efficacy of the urination care support system (Lilli care) to a health visitor
Scientific Title:Acronym
Examination about the change of usability and the self-efficacy of the urination care support system (Lilli care) to a health visitor
Region
| Japan |
Condition
Condition
The health visitor who had you agree to participation in this study in the home nursing station which study cooperation was got from
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For pivot support, need of nursing care elderly people resident in an area, it is intended that we examine a change of the self-efficacy in approximately the use of the health visitor using an urination care support system (Lilli care) which we made.
Basic objectives2
Others
Basic objectives -Others
A health visitor can take care of urination assessment using an urination care support system (Lilli care) which we made continuously or, for pivot support, need of nursing care elderly people resident in an area, examines it
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy about the excretion care
Before intervention and intervention three months later
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A health visitor receives assessment care according to the instructions using Lilli care.
Interventions/Control_2
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
The health visitor who had you agree to participation in this study in the home nursing station which study cooperation was got from
Key exclusion criteria
No
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Yokoyama |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Nursing
Zip code
4748511
Address
7-430, Moriokacho, Obu-shi, Aichi
TEL
0562-46-2311
tyokoyama@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Yokoyama |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Nursing
Zip code
4748511
Address
7-430, Moriokacho, Obu-shi, Aichi
TEL
0562-46-2311
Homepage URL
tyokoyama@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic, benefit reciprocity screening committee
Address
7-430, Moriokacho, Obu-shi, Aichi
Tel
0562462311
tyokoayma@ncgg.go.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
| 2019 | Year | 07 | Month | 12 | 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
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 12 | Day |
Last modified on
| 2020 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040935
