UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039323 |
|---|---|
| Receipt number | 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 17:43:49 |
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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
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
mizuesuzuki@gmail.com
Sponsor or person
Institute
Hamamatsu Univerisyt School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044840
