UMIN-CTR Clinical Trial

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
Email	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
Email	urabem@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041440