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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039323
Receipt No. R000044840
Scientific Title The effect of the dementia nursing program in the acutee hospital aiming at person centred care: Analysis by the focus group interview of elderly people playing patients with dementia
Date of disclosure of the study information 2020/01/30
Last modified on 2020/01/30

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Basic information
Public title The effect of the dementia nursing program in the acutee hospital
Acronym The effect of the dementia nursing program in the acutee hospital
Scientific Title The effect of the dementia nursing program in the acutee hospital aiming at person centred care:
Analysis by the focus group interview of elderly people playing patients with dementia
Scientific Title:Acronym The effect of the dementia nursing program in the acutee hospital
Region
Japan

Condition
Condition Unavailable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to clarify the effect of the program developed
as the nursing simulation program that assumed night deliriousness using the simulated patient for the nurses of the acute hospital.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Interview investigation

Key secondary outcomes Unavailable

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 NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Fall prevention program
Interventions/Control_2 Fall prevention program
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
110 years-old >
Gender Male and Female
Key inclusion criteria Elderly people with dementia, care staff
Key exclusion criteria Elderly people without dementia, notcare staff
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Mizue
Middle name
Last name Suzuki
Organization Hamamatsu Univerisyt School of Medicine

Division name Faculty of Nursing
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL 053-435-2826
Email mizuesuzuki@gmail.com

Public contact
Name of contact person
1st name Mizue
Middle name
Last name Suzuki
Organization Hamamatsu Univerisyt School of Medicine
Division name Faculty of Nursing
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL 053-435-2826
Homepage URL
Email mizuesuzuki@gmail.com

Sponsor
Institute Hamamatsu Univerisyt School of Medicine
Institute
Department

Funding Source
Organization Technology promotion mechanism
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 Hamamatsu Univerisyt School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel 053-435-2831
Email mizuesuzuki@gmail.com

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 01 Month 30 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
2019 Year 12 Month 18 Day
Date of IRB
2019 Year 12 Month 18 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2022 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 30 Day
Last modified on
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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