UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036393 |
|---|---|
| Receipt number | R000041440 |
| Scientific Title | Nonpharmacologic intervention for Behavioral and psychological symptoms of dementia using the positive emotions of patients with Alzheimer's disease |
| Date of disclosure of the study information | 2019/04/03 |
| Last modified on | 2021/10/05 17:22:18 |
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Basic information
Public title
Nonpharmacologic intervention for Behavioral and psychological symptoms of dementia using the positive emotions of patients with Alzheimer's disease
Acronym
Nonpharmacologic intervention for BPSD for patients with Alzheimer's disease
Scientific Title
Nonpharmacologic intervention for Behavioral and psychological symptoms of dementia using the positive emotions of patients with Alzheimer's disease
Scientific Title:Acronym
Nonpharmacologic intervention for BPSD for patients with Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Positive emotion is brought out from a patient with Alzheimer's disease by non-pharmacological intervention, and research into the change in BPSD, daily living behavior, language quantity and contents of language, are carry out.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of BPSD using Neuropsychiatric Inventory.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention using nostalgic music and reminiscence.Four times, two months.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Elderly people diagnosed with Alzheimer's disease.
2. Elderly persons with Alzheimer's disease admitted to a mental hospital.
3. Conversation is possible.
4. There is no problem with vision and hearing.
Key exclusion criteria
1.Serious behavior and psychological symptoms
2.A doctor in charge judges that participation in the research is unsuitable.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mie |
| Middle name | |
| Last name | Urabe |
Organization
Kyoto Prefectural University of Medicine
Division name
School of Nursing
Zip code
602-0857
Address
410 Nakagoryo-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-212-5444
urabem@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Mie |
| Middle name | |
| Last name | Urabe |
Organization
Kyoto Prefectural University of Medicine
Division name
School of Nursing
Zip code
602-0857
Address
410 Nakagoryo-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-212-5444
Homepage URL
urabem@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Kyoto Prefectural University of Medicine
Address
410 Nakagoryo-cho, Kamigyo-ku, Kyoto, Japan
Tel
075-212-5444
urabem@koto.kpu-m.ac.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 | 04 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now, the intervention of face to face at psychiatric hospital is difficult because of COVID-19.
So we had to stop the intervention for a while.
In the future, we will apply for changing methods except for face-to-face
Management information
Registered date
| 2019 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041440
