UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019575 |
|---|---|
| Receipt number | R000022632 |
| Scientific Title | Are elderly persons with dementia in mental hospital able to perform his/her meaningful occupation?:Analysis of patient's narartives |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2015/10/30 16:03:58 |
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Basic information
Public title
Are elderly persons with dementia in mental hospital able to perform his/her meaningful occupation?:Analysis of patient's narartives
Acronym
Are elderly persons with dementia in mental hospital able to perform his/her meaningful occupation?
Scientific Title
Are elderly persons with dementia in mental hospital able to perform his/her meaningful occupation?:Analysis of patient's narartives
Scientific Title:Acronym
Are elderly persons with dementia in mental hospital able to perform his/her meaningful occupation?
Region
| Japan |
Condition
Condition
Alzheimer dementia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether elderly persons with dementia in mental hospital are able to perform his/her meaningful occupation,through the analysis of one's narratives.
Basic objectives2
Others
Basic objectives -Others
Narratives of elderly persons with dementia in mental hospital
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Narratives of elderly persons with dementia in mental hospital
Performing the "Assessment by the Picture Cards for the Elderly with Dementia(APCD)
Key secondary outcomes
Non-verbal reaction
- Facial expression
- Tone of voice, intonation
- Speak speed
- Time to start talking
- Body movement
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
satisfy the following 1)-4)
1)patients in the hospital to dementia specialized ward of Showa University Karasuyama hospital
2)patients diagnosed with Alzheimer-type dementia in a designated psychiatrist
3)patients that can be implemented
APCD
1.patient score of Hasegawa's Dementia Scale for Revised(HDS-R)is equal to or greater than 10 points
2.patients that can be a simple conversation in life in the ward
4)patient consent was obtained by the document from the person and proxies for participation in this study
Key exclusion criteria
fall under any of the following1),2)
1)patient implementation of APCD is difficult
1.centralized difficult patient by behavioral and psychological symptom of dementia(BPSD)is serious
2.Conversation difficult patients (irritability,irritability hyperactivity)by BPSD is serious
2)patients who have been determined ineligible by the decision of a designated psychiatrist
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisayoshi SUZUKI |
Organization
Showa University
Division name
School of Nursing and Rehabilitation Sciences
Zip code
Address
1865 Tohka-ichiba-machi Midori-ku, 226-8555 Yokohama, Japan
TEL
045-985-6500
otsuzuki@nr.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi KOBAYASHI |
Organization
1. Showa University 2. Showa University Karasuyama Hospital
Division name
1. School of Nursing and Rehabilitation Sciences 2.Department of Occupational therapy
Zip code
Address
1. 1865 Tohka-ichiba-machi Midori-ku,226-8555 Yokohama, Japan 2.6-11-11 Kita-karasu-yama se-ta-ga-ya
TEL
1.045-985-6500.2.03-3300-523
Homepage URL
seetaka1015@yahoo.co.jp
Sponsor or person
Institute
Showa University Karasuyama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Address
Tel
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
| 2015 | Year | 11 | Month | 02 | 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
| 2015 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
interview
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2015 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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