UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046431 |
|---|---|
| Receipt number | R000052980 |
| Scientific Title | Changes in Casual Music Therapy Intervention for Irritation, Behavioral Abnormalities and Anxiety in Patients with Frontotemporal dementia |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/06/25 14:38:36 |
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Basic information
Public title
Changes in Casual Music Therapy Intervention for Irritation, Behavioral Abnormalities and Anxiety in Patients with Frontotemporal dementia
Acronym
Changes in Casual Music in Patients with Frontotemporal dementia
Scientific Title
Changes in Casual Music Therapy Intervention for Irritation, Behavioral Abnormalities and Anxiety in Patients with Frontotemporal dementia
Scientific Title:Acronym
Changes in Casual Music in Patients with Frontotemporal dementia
Region
| Japan |
Condition
Condition
Frontotemporal dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of music therapy on Frontotemporal dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BEHAVE-AD
DBD
Key secondary outcomes
1.Record patient behavior changes.
2. Evaluation before and after implementation.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Music therapy
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Patients with frontotemporal dementia with impatience, behavioral abnormalities, and anxiety requiring isolation
Key exclusion criteria
Alzheimer's disease
Lewy body dementia
Cerebrovascular demetia
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Hashida |
Organization
Social medical corporation Hokutokai
Division name
Nursing department
Zip code
561-0803
Address
1-9-1 Siroyama.Toyonaka City.Osaka.Japan
TEL
06-6865-1211
nur@hokuto-kai.com
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Hashida |
Organization
Social medical corporation Hokutokai
Division name
Nursing department
Zip code
561-0803
Address
1-9-1 Siroyama.Toyonaka City.Osaka.Japan
TEL
06-6865-1211
Homepage URL
nur@hokuto-kai.com
Sponsor or person
Institute
Social medical corporation Hokutokai
Institute
Department
Personal name
Funding Source
Organization
Social medical corporation Hokutokai
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee, Social medical corporation Hokutokai
Address
1-9-1 Siroyama.Toyonaka City.Osaka.Japan
Tel
06-6865-1211
clin-res@hokuto-kai.com
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
| 2022 | Year | 04 | Month | 01 | 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
1
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
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 20 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052980
