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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00448318
Registration number
NCT00448318
Ethics application status
Date submitted
14/03/2007
Date registered
16/03/2007
Date last updated
16/03/2007
Titles & IDs
Public title
Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
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Scientific title
Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
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Secondary ID [1]
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WKG_07_BB
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Alzheimer's Disease
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Dementia, Vascular
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Lewy Body Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Mental Health
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Other mental health disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mini Mental State Examination: baseline cf. post intervention scores.
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Hierarchic Dementia Scale: baseline cf. post intervention scores.
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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Geriatric Depression Scale: baseline cf. post intervention scores.
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Assessment method [3]
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Timepoint [3]
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Primary outcome [4]
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Note: post intervention measures taken within 24 hours of final therapeutic intervention session
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [1]
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EEG fast/slow ratio: baseline cf. post intervention scores.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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EEG Coherence: baseline cf. post intervention scores.
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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EEG evoked potentials:baseline cf. post intervention scores.
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Note: post intervention measures taken within 24 hours of final therapeutic intervention session
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Assessment method [4]
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Timepoint [4]
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Eligibility
Key inclusion criteria
* Clinical diagnosis of dementia
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* delirium
* acute medical conditions (eg pneumonia, cardiac failure)
* primary psychiatric conditions (eg schizophrenia)
* severe hearing impairment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2007
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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National Ageing Research Institute - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
National Ageing Research Institute, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Dementing syndromes are, for the most part, incurable. People with dementia become highly dependent and frequently have to move from their homes into residential aged care facilities. Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success. Increasingly, people with dementia, their families and carers are turning to supplementary or alternative approaches to the management of their symptoms. There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia. These include reports of improved memory, improved language skills, reduced anxiety and depression, reductions in agitation and disruptive behaviours and better social relationships with family, peers and carers. However, the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers. This clinical trial will examine the effects of a music therapy intervention. The study will recruit 180 patients in sub-acute hospital wards. Participants will be randomly placed in groups that receive either occupational therapy or music therapy. Before the therapy programs begin, we will use questionnaires to measure memory function, language ability, orientation and mood. We will also record brain activity from the surface of the scalp, blood pressure and pulse to examine physiological responses. The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy. We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions. This will provide information about the immediate effects of music on mood and social interaction. The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia. This understanding will be useful in developing better applications of music therapy. It will also add to our current knowledge about how the various diseases cause the problems they do. In summary, the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence.
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Trial website
https://clinicaltrials.gov/study/NCT00448318
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jonathan B Barber, PhD
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Address
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National Ageing Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jonathan B Barber, PhD
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Address
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Country
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Phone
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+61 3 8387 2638
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00448318
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