UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021966 |
|---|---|
| Receipt number | R000025324 |
| Scientific Title | Project for Promotion of Community Care Program for People Living With Dementia |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/05/29 17:20:59 |
* 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
Project for Promotion of Community Care Program for People Living With Dementia
Acronym
Development of Japanese version of BPSD Program of Care
Scientific Title
Project for Promotion of Community Care Program for People Living With Dementia
Scientific Title:Acronym
Development of Japanese version of BPSD Program of Care
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics | Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Japanese version of BPSD Program of Care that has been developed in Sweden to promote psychosocial approaches to challenging behaviors of people with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and severity of challenging behavior among people with dementia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A professional caregiver evaluates frequency and severity of challenging behavior of a person with dementia. Based on the measurement, the caregiver establishes a care plan of daily program that includes contents and frequency of basic communication approach, physical activity, calm environment, massage, music/song, and so on. The caregiver implements the program according to the care plan, and re-evaluates the challenging behavior.
Interventions/Control_2
A professional caregiver evaluates frequency and severity of challenging behavior of a person with dementia. The caregiver does not establish a care plan, either implement the 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A client of participating long-term care providers and has a diagnosis of dementia
6-10 clients from one providers who started the use of service most recently.
Key exclusion criteria
Younger than 65 years old
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miharu Nakanishi |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Mental Health Promotion project
Zip code
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506 JAPAN
TEL
+81-3-6834-2292
nakanishi-mh@igakuken.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Endo |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Mental Health Promotion Project
Zip code
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506 JAPAN
TEL
+81-3-6834-2294
Homepage URL
endo-kr@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan government
Organization
Division
Category of Funding Organization
Local Government
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
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.3233/JAD-171077
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 18 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025324
