UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037354 |
|---|---|
| Receipt number | R000040933 |
| Scientific Title | Support resident in an area required, exploratory examination of the effect of the urination care support system (Lilli care) to need of nursing care elderly people |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2020/07/14 17:07:06 |
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Basic information
Public title
Support resident in an area required, exploratory examination of the effect of the urination care support system (Lilli care) to need of nursing care elderly people
Acronym
Support resident in an area required, exploratory examination of the effect of the urination care support system (Lilli care) to need of nursing care elderly people
Scientific Title
Support resident in an area required, exploratory examination of the effect of the urination care support system (Lilli care) to need of nursing care elderly people
Scientific Title:Acronym
Support resident in an area required, exploratory examination of the effect of the urination care support system (Lilli care) to need of nursing care elderly people
Region
| Japan |
Condition
Condition
1.Person of support 1.2 receiving temporary nursing at home required and need of nursing care 1-3
2.Person 65 years or older
3.The person who has either lower urinary tract symptom such as urinary retention, urinary incontinence, the urinary frequency
4.The person who was able to acquire a consent form from the person
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 lower urinary tract symptom because a health visitor takes care of urination assessment using an urination care support system (Lilli care) which we made whether the improvement of the functions of others is done.
Basic objectives2
Others
Basic objectives -Others
We examine relations with the improvement of the functions of elderly people with a lower urinary tract symptom.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower urinary tract symptom
International Prostate Symptom Score
Overactive Bladder Symptom Score
Before intervention and intervention one month 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 inputs according to Lilli care, and necessary care contents are displayed.According to displayed care contents, we care to subjects every visit.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A person of support 1.2 receiving temporary nursing at home required and need of nursing care 1-3
2.Person 65 years or older
3. The person who has either lower urinary tract symptom such as urinary retention, urinary incontinence, the urinary frequency
4. The person who was able to acquire a consent form from the person
Key exclusion criteria
1.The person who detains the urinary system catheters such as urethra indwelling catheters
2.The person who has the malignant tumor of the lower urinary tract
Target sample size
100
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
0562-46-2311
tyokoyama@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 | 09 | Month | 12 | 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
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
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=R000040933
