UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019575
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email seetaka1015@yahoo.co.jp

Sponsor
Institute Showa University Karasuyama Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.