UMIN-CTR Clinical Trial

Basic information
Public title	Examination of Effective Nursing Intervention for Music Therapy for Severe Dementia Elderly Person
Acronym	Music Intervention to Improve QOL of Elderly Individuals with Severe Dementia
Scientific Title	Examination of Effective Nursing Intervention for Music Therapy for Severe Dementia Elderly Person
Scientific Title:Acronym	Music Intervention to Improve QOL of Elderly Individuals with Severe Dementia
Region	Japan

Condition
Condition	Severe Alzheimer's disease
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Short-term effects To investigate the utility of music intervention for reducing BPSD, we examined the short- and long-term effects of passive and interactive approaches using individualized music associated with special memories to evoke positive emotions and recollection in elderly individuals with severe dementia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Short-term effects: we evaluated immediately before and after the music intervention using the autonomic nerve index and the Faces scale. Long-term effects: We evaluated BEHAVE-AD . The evaluations were conducted prior to the study (baseline), after the tenth music intervention, and 3 weeks after the intervention had ended. Long-term effects: we calculated the number of minutes of behavior that indicated responsiveness to the music intervention in the Passive and Interactive groups every session.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The Passive group participants listened to music presented through speakers in own room.The intervention was performed for 30 minutes once a week for 10 weeks (10 sessions in total).we approaches using individualized music associated with special memories.
Interventions/Control_2	The Interactive group participants selected and played music through speakers, and participated in interactive activities (playing, singing, dancing, etc.) with a music facilitator.The intervention was performed for 30 minutes once a week for 10 weeks (10 sessions in total).we approaches using individualized music associated with special memories.
Interventions/Control_3	The Control group participants spent time with caregivers in their own room as usual, without any music intervention (silent environment).
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The selection criteria were as follows. 1.Alzheimer'stype dementia according the diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders. 2. 4th edition; severity was classified at level 3, indicating severe dementia as specified by the Clinical Dementia Rating scale. 3. aged 65 years or more.
Key exclusion criteria	The exclusion criteria were as follows. 1.acoustic disturbance. 2. experience of playing musical instruments. 3. history of heart disease, hypertension, or diabetes (because changes in autonomic nervous system were used as an index).
Target sample size	39

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mayumi Sakamoto
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Nursing
Zip code
Address	7-5-10, Tomogaoka, Suma-ku, Kobe-city 654-0142 Hyogo,Japan.
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Mayumi Sakamoto
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Nursing
Zip code
Address	7-5-10, Tomogaoka, Suma-ku, Kobe-city 654-0142 Hyogo,Japan
TEL
Homepage URL
Email

Sponsor
Institute	Kobe University Graduate School of Health Sciences
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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IRB Contact (For public release)
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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	2012 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2007 Year 04 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 29 Day
Last modified on	2012 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010337

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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