UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037254 |
|---|---|
| Receipt number | R000042479 |
| Scientific Title | Research project for dissemination of dementia care programme |
| Date of disclosure of the study information | 2019/09/13 |
| Last modified on | 2020/10/10 14:22:44 |
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Basic information
Public title
Dissemination and implementation of psychosocial dementia care programme in Japan: an observational study of process evaluation between different service models
Acronym
A process observation and evaluation of dementia care programme
Scientific Title
Research project for dissemination of dementia care programme
Scientific Title:Acronym
Research project for dissemination of dementia care programme
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics | Psychiatry | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate the barriers to disseminate and implement a psychosocial dementia care programme that has been developed by Tokyo Metropolitan Institute of Medical Science as a delegated project of Tokyo Metropolitan government. We thus plan to introduce the programme into different types of service providers, evaluate the implementation process, and compare the process between the service types.
Basic objectives2
Others
Basic objectives -Others
Process evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of efforts and time spent for care professionals to hold a multidisciplinary discussion meeting to evaluate level of neuropsychiatric symptoms, to identify unmet needs, and to establish an action plan; time spent to input evaluation into the online tool
Key secondary outcomes
Participating care professionals' level of understanding and competence in dementia care before and after training course; level of neuropsychiatric symptoms of persons with dementia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver | Other |
Interventions/Control_1
Participating care professionals will complete a 1-day training course of the programme. Each professional will introduce the programme into 2 persons with dementia during 6 months. The professional will hold 3-time multidisciplinary discussion meetings to evaluate level of neuropsychiatric symptoms, identify unmet needs, and establish an action plan for the person with dementia.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons with dementia diagnosis who use following types of long-term care insurance services: in-home care management, in-home multiple service, group home, or special nursing home.
Key exclusion criteria
The person with dementia and/or his/her surrogate decision maker does not provide informed consent to participate in the study; the person is in an acute deterioration of physical or mental functioning.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Nakanishi |
| Middle name | |
| Last name | Miharu |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Mental Health Promotion Project
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
+81-3-6834-2292
nakanishi-mh@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Niimura |
| Middle name | |
| Last name | Junko |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Mental Health Promotion Project
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
+81-3-6834-2293
Homepage URL
niimura-jk@igakuken.or.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Center for Medical Research Cooperation, Tokyo Metropolitan Institute of Medical Science
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel
+81-3-6834-2391
renkei@igakuken.or.jp
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
| 2019 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3233/ADR-200235
Number of participants that the trial has enrolled
125
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2020 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042479
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
