UMIN-CTR Clinical Trial

Basic information
Public title	Survey on app applicability of a physician-nurse-caregiver collaborative system for the prevention of indwelling urinary catheter blockage
Acronym	Survey on app applicability
Scientific Title	Survey on app applicability of a physician-nurse-caregiver collaborative system for the prevention of indwelling urinary catheter blockage
Scientific Title:Acronym	Survey on app applicability of a physician-nurse-caregiver collaborative system for the prevention of indwelling urinary catheter blockage
Region	Japan

Condition
Condition	home visiting nurse physician care giver
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The object of this study is to evaluate the feasibility of using the application by visiting nurses, caregivers, and physicians.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Possibility of use by visiting nurses, caregivers, and doctors
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1) 50 nurses (1)Visiting nurse (2)Have experience of indwelling bladder catheter (3)Use PC or smartphone 2) 50 caregivers (1) A caregiver who has an indwelling bladder catheter is being cared for at home. (2)Use PC or smartphone 3)50 physicians (1) Experience with patients who have indwelling bladder catheters (2)Experienced in providing home nursing care instructions (3)Use PC or smartphone
Key exclusion criteria	nurse not include associate nurses
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Shuko Middle name Last name Maeda
Organization	Kanazawa Medical University
Division name	School of Nursing
Zip code	92002963
Address	1-1 1-1Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
TEL	076-286-2211
Email	mshuko@kanazawa-med.ac.jp

Public contact
Name of contact person	1st name Shuko Middle name Last name Maeda
Organization	Kanazawa Medical University
Division name	School of Nursing
Zip code	92002963
Address	1-1Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
TEL	076-286-2211
Homepage URL
Email	mshuko@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research (B:No.16H05601)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Ethics Review Committee of Kanazawa Medical University
Address	1-1Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
Tel	076-286-2211
Email	tiken@kanazawa-med.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	2020 Year 02 Month 17 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	150
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	No longer recruiting
Date of protocol fixation	2020 Year 02 Month 06 Day
Date of IRB	2020 Year 02 Month 06 Day
Anticipated trial start date	2020 Year 02 Month 13 Day
Last follow-up date	2020 Year 02 Month 16 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	No matter

Management information
Registered date	2020 Year 02 Month 16 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045040