UMIN-CTR Clinical Trial

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
Email	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
Email	tyokoyama@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040933