Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000616875
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
8/06/2012
Date last updated
27/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of music on agitated behaviours in older people with dementia.
Scientific title
The Effect of Music on Agitated Behaviours in Older People with Dementia: A Randomised Cross-over Study.
Secondary ID [1] 280587 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitated behaviours in older people with dementia. 286582 0
Condition category
Condition code
Mental Health 286856 286856 0 0
Other mental health disorders
Neurological 286957 286957 0 0
Dementias
Alternative and Complementary Medicine 286958 286958 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare the effect of music to the effect of a reading group on disruptive behaviours. The intervention activities are, i) participants were engaged in a group music making activity through singing, instrumental performance and where appropriate, movement or ii) engaged in a group reading activity conducted in a separate room to where the music program. Both activities occurred three times a week for 40 minutes for eight weeks. On completion, participants were exposed to the opposite activity for another eight weeks. A five-week ‘washout’ period was included between cross-over to reduce potential carryover effects.
Intervention code [1] 284968 0
Behaviour
Intervention code [2] 285046 0
Treatment: Other
Comparator / control treatment
Reading group
Control group
Active

Outcomes
Primary outcome [1] 287214 0
Agitated behaviours - 14 short-item Cohen-Mansfield Agitation Inventory (CMAI).
Timepoint [1] 287214 0
3 timepoints - At baseline, mid-point (after the first eight-week intervention arm) and post-intervention (after the second eight-week intervention arm)
Secondary outcome [1] 297646 0
Depression - Geriatric Depression Scale (GDS)
Timepoint [1] 297646 0
3 timepoints - At baseline, mid-point (after the first eight-week intervention arm) and post-intervention (after the second eight-week intervention arm)
Secondary outcome [2] 297793 0
Quality of life - Dementia Quality of Life (DQol) and Resident and Staff Observation Checklist - Quality of Life (RSCO-Qol)
Timepoint [2] 297793 0
3 timepoints - At baseline, mid-point (after the first eight-week intervention arm) and post-intervention (after the second eight-week intervention arm)
Secondary outcome [3] 297794 0
Anxiety - Rating Anxiety in Dementia (RAID)
Timepoint [3] 297794 0
3 timepoints - At baseline, mid-point (after the first eight-week intervention arm) and post-intervention (after the second eight-week intervention arm)
Secondary outcome [4] 297859 0
Participant's severity of dementia
Timepoint [4] 297859 0
Assessed by trained and experienced RAs blinded to treatment groups at baseline and post-intervention on
the Mini-Mental State Exam (MMSE) (Folstein et
al., 1975)

Eligibility
Key inclusion criteria
1) A medical diagnosis of mild to moderate dementia or probable dementia (i.e. a cognitive impairment level of 12-24 on the Mini Mental State Exam (Folstein, Folstein, & McHugh, 1975), or features consistent with dementia of Alzheimer’s type as per DSM—IV (American Psychiatric Association, 1994).
2) A documented behavioural history of agitation and aggression on nursing or medical records within the previous month to recruitment.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A Mini-Mental State Exam (MMSE) score that falls outside the range of 12-24.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A biostatistician not associated with data collection, will conduct the randomization process using a computer generated program that will outline the different ordering of treatments for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The biostatistician’s non-association with data collection will safeguard against researcher bias. All data collection will be undertaken by Research Assistants (RAs) who are ‘blinded’ or unaware of the participants’ treatment groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
14/09/2009
Date of last participant enrolment
Anticipated
Actual
2/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285342 0
Government body
Name [1] 285342 0
National Health and Medical Research Council (NHMRC) Dementia Research Grants Program
Country [1] 285342 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 284235 0
None
Name [1] 284235 0
Address [1] 284235 0
Country [1] 284235 0
Other collaborator category [1] 260831 0
Other Collaborative groups
Name [1] 260831 0
RSL Care
Address [1] 260831 0
301 Wickham Street
Fortitude Valley
QLD 4006
Country [1] 260831 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287355 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287355 0
Ethics committee country [1] 287355 0
Australia
Date submitted for ethics approval [1] 287355 0
Approval date [1] 287355 0
01/04/2008
Ethics approval number [1] 287355 0
NRS/08/08/HREC
Ethics committee name [2] 287394 0
RSL Care
Ethics committee address [2] 287394 0
Ethics committee country [2] 287394 0
Australia
Date submitted for ethics approval [2] 287394 0
Approval date [2] 287394 0
30/07/2008
Ethics approval number [2] 287394 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34241 0
Prof Prof Marie Cooke
Address 34241 0
School of Nursing and Midwifery
Griffith University
170 Kessels Road
Nathan, Qld, 4111
Country 34241 0
Australia
Phone 34241 0
61 7 37355253
Fax 34241 0
Email 34241 0
[email protected]
Contact person for public queries
Name 17488 0
Professor Marie Cooke
Address 17488 0
Professor of Nursing School of Nursing and Midwifery
Griffith University
Nathan Campus
170 Kessels Road
Nathan
QLD 4111
Country 17488 0
Australia
Phone 17488 0
+61 7 3735 5253
Fax 17488 0
+61 7 3735 5431
Email 17488 0
[email protected]
Contact person for scientific queries
Name 8416 0
Professor Marie Cooke
Address 8416 0
Professor of Nursing School of Nursing and Midwifery
Griffith University
Nathan Campus
170 Kessels Road
Nathan
QLD 4111
Country 8416 0
Australia
Phone 8416 0
+61 7 3735 5253
Fax 8416 0
+61 7 3735 5431
Email 8416 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.