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Trial registered on ANZCTR


Registration number
ACTRN12617000088347
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
17/01/2017
Date last updated
17/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Listening to preferred music to reduce risky wandering: A feasibility study
Scientific title
Listening to preferred music to reduce risky wandering in people with severe dementia in residential aged care
Secondary ID [1] 290469 0
Nil other
Universal Trial Number (UTN)
U1111-1189-5507
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 300835 0
Wandering 300836 0
Condition category
Condition code
Neurological 300662 300662 0 0
Dementias
Neurological 301152 301152 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non-drug trial
Participants with severe dementia living in long term care with a history of wandering will listen to a selection of preferred music as selected by the participants next of kin. The music will be downloaded on to an iPod shuffle and listened to through head phones or speakers depending on preference. There are 2 conditions (2 participating facilities):
Condition 1: Each participant will listen to their selection of music in a quiet area for 20 mins, 5 days per week (Mon-Fri), for 3 weeks, 30 minutes before an individuals unique peak activity period.
Condition 2: Each participant will listen to their selection of music in a quiet area for 20 mins, 5 days per week (Mon-Fri), for 3 weeks, at a randomized time not including 30 minutes before an individuals unique peak activity period. Participants will be randomised to any 20 minute time period not 30 mins prior to peak activity periods or during scheduled meal times between 8am-6.30pm Mon-Fri.
Cluster randomization at the level of the facility was used to assign conditions - Facility 1 assigned condition 1; Facility 2 assigned condition 2. Condition assignment was chosen by a colleague not associated with the project. Participants only received 1 condition
The intervention will be delivered by trained research assistants who will remain with the participant during the intervention to observe reaction to the music (duration of time listening to music) and mood using Lawton's Modified Behavior Stream. To measure protocol fidelity, the person conducting the music session completed a checklist of essential protocol items (pre music session checklist (asked participant if they would like to listen to music, wearing appropriate clothing, elimination needs attended to, offered a drink), time music session commenced, duration of music session, mood that participant listen to music (headphones/speaker), location that music session was conducted, and comments about deviations from protocol). 10% of all interventions were observed by the principle investigator or project manager for inter rater reliability.
Intervention code [1] 296321 0
Behaviour
Intervention code [2] 296552 0
Prevention
Comparator / control treatment
Comparisons will be made between the two conditions as well between weeks (Baseline (1 week before intervention), weekly during the 3 week intervention, week after the 3 week intervention)
Pre and post measures of wandering behaviour (steps taken, intrusion into private space, pattern of ambulation) by direct observation 2 x 2hr/week/participant, agitation, mood (Lawton's Modified Behavior Stream - collected during each intervention and pre or post wandering observations)
Control group
Active

Outcomes
Primary outcome [1] 300083 0
Feasibility of following the intervention protocol through checklist completed at the end of each intervention session and congruence with a second observer of 10% of all interventions delivered
Timepoint [1] 300083 0
During each listening to music session the RA will observe the participant's mood to assess acceptability . At the end of each listening to music session the RA will complete a checklist of items included in the protocol
Secondary outcome [1] 328983 0
Composite outcomes
Characteristics of wandering: frequency of ambulation (steps taken using Actigraph activity monitor), boundary transgression (frequency and duration of entry into private space collected by direct observation), pattern of ambulation (lapping, pacing, random, direct collected using direct observation).
Timepoint [1] 328983 0
Baseline (pre intervention - Week 1), during intervention (Week 2-4) and post intervention (week 5).
RA observe each participant for 2 hours 2 x per week - 1 x in peak activity periods, 1 x outside peak activity periods. For IRR 10% of all observations have 2 observers - aim for 95% congruence. re training to occur if not acheived
Secondary outcome [2] 329846 0
Agitation - Cohen Mansfield Agitation Inventory - Short Form (CMAI-SF)
Timepoint [2] 329846 0
Baseline (pre intervention - start Week 1), during intervention (Start Weeks 2-4) and post intervention (start week 5).
Secondary outcome [3] 329851 0
Staff and family perceptions of benefits and acceptability of music program: Composite secondary outcome
Timepoint [3] 329851 0
Interviews conducted in the weeks after the 3 week listening to music program is completed with staff present during the listen ting to music program.
Secondary outcome [4] 330320 0
Acceptability of the use of headphones or speakers (mode of listening to music directed by person with dementia or family member) to listen to music
Timepoint [4] 330320 0
The duration of time that the participant listen s to music will be recorded at the end of each listening to music session by the RA observing the session
Secondary outcome [5] 330783 0
Are participants able to listen to music for a period of 20 minutes per day five times per week for 3 weeks?
Timepoint [5] 330783 0
During each listening to music session, the participant will be observed by the research assistant who will note when the session is ended and why it ends i.e. by participant or research assistant
Secondary outcome [6] 330784 0
Do participants enjoy listening to music?
Timepoint [6] 330784 0
At the end of each listening to music session, participants will be asked if they enjoyed the music session.
Secondary outcome [7] 330785 0
Immediate pleasure
Timepoint [7] 330785 0
During each listening to music session the RA will observe the participant and collect data related to positive (pleasure, interest), neutral and negative (sadness, worry/anxiety, anger) affect will be collected (Lawton's Modified Behavior Stream)
Secondary outcome [8] 330787 0
Reliability of staff to identify residents with dementia who wander and exhibit BT at an intensity that is observable
Timepoint [8] 330787 0
Congruence between identified potential participants with inclusion criteria

Eligibility
Key inclusion criteria
> 55 years
Severe dementia as documented in medical history and confirmed with Global Deterioration Scale
Positive history of wandering as reported by care staff and confirmed using Revised Algase Wandering Scale
Independently ambulant (wheelie walker and walking stick acceptable
Not experiencing an acute mental illness
Able to listen to music
Enjoys listening to music
Walks > 5000 step per day
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not severe dementia
Not independently ambulant
Does not walk > 5000 steps per day
Experiencing an acute psychotic episode

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A colleague not associated with the project chose one of two folded pieces of paper with condition 1 and condition 2 written on them. The first one chosen was allocated to Facility 1 and Facility 2 received the other.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To compare effect of intervention, repeated measures ANOVA will be used to compare mean frequency of CMAI scores and wandering observations across the 5 weeks of the program

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
28/02/2017
Actual
Date of last data collection
Anticipated
31/05/2017
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 14552 0
4022 - Rothwell

Funding & Sponsors
Funding source category [1] 294882 0
Other Collaborative groups
Name [1] 294882 0
Dementia Collaborative Research Centre
Country [1] 294882 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd
Kelvin Grove, Qld 4059
Country
Australia
Secondary sponsor category [1] 293720 0
None
Name [1] 293720 0
Address [1] 293720 0
Country [1] 293720 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296260 0
Queensland University of Technology
Ethics committee address [1] 296260 0
Victoria Park Rd
Kelvin Grove, Qld 4059
Ethics committee country [1] 296260 0
Australia
Date submitted for ethics approval [1] 296260 0
12/05/2016
Approval date [1] 296260 0
25/07/2016
Ethics approval number [1] 296260 0
1600000627

Summary
Brief summary
In the absence of effective alternatives, residential aged care (RAC) still resort to using pharmacological interventions, such as antipsychotic and sedating medications, to manage behaviours of dementia despite there being strong evidence that these are ineffective and are associated with severe adverse outcomes for the person with dementia. Non-pharmacological interventions are recommended as best practice to mitigate adverse outcomes associated with behaviours of dementia. There is considerable evidence that listening to preferred music reduces agitation in dementia. However, there is also robust evidence that dementia-related wandering and agitation are distinct phenomenon. Therefore we cannot assume that an intervention effective in reducing agitation will also reduce aspects of wandering that incur risk or result in negative outcomes for the person with dementia. There have been no known trials of music based interventions for people with dementia who wander, despite the pressing need for non-pharmacological interventions in this area. The goal of this applied research is to test the feasibility of using an intervention protocol, previously found to be effective in reducing agitation for people with dementia, to determine if it can be used with people who wander.
Therefore the aims of this feasibility study are:
1) For people with dementia who wander and exhibit boundary transgression (BT) (entry into out of bounds and hazardous areas) in residential aged care (RAC):
a. Is listening to music for a period of 20 minutes five times per week for 3 weeks tolerated?
b. Is listening to the music via ear bud head phones tolerated?
c. Do participants enjoy listening to the music?
2) Does listening to preferred music daily for 20 minutes under two conditions:
a) Reduce risky aspects of wandering including frequent ambulation and boundary transgression (BT)?
b) Reduce participant agitation?
c) Provide immediate pleasure to the participant?
3) Are facility care staff able to reliably identify residents with dementia who wander and exhibit BT at an intensity that is observable?
4) Do care staff and family members perceive the music intervention to be beneficial for resident with dementia who wander?

This feasibility study will use cluster randomisation (Facility 1 and Facility 2) to trial two intervention conditions:
Condition 1: Daily (Mon-Fri) session of listening to preferred music for 20 minutes, 30 minutes before unique peak activity period
Condition 2: Daily (Mon-Fri) session of listening to preferred music for 20 minutes at a randomly selected time between 10 am-7pm not including 30 mins prior to individual peak activity periods.
Pre, during and post intervention measures of wandering characterisitics (frequency, boundary transgression, pattern), mood and agitation will be collected.
Trial website
Trial related presentations / publications
Public notes
Participating nursing homes
Beaumont Care Rothwell and Seabrae Manor Rothwell

Contacts
Principal investigator
Name 70178 0
Dr Margaret MacAndrew
Address 70178 0
QUT
Victoria Park Rd
Level 3 N Block
Kelvin Grove, Qld 4059
Country 70178 0
Australia
Phone 70178 0
+61 7 31385956
Fax 70178 0
Email 70178 0
[email protected]
Contact person for public queries
Name 70179 0
Margaret MacAndrew
Address 70179 0
QUT
Victoria Park Rd
Level 3 N Block
Kelvin Grove, Qld 4059
Country 70179 0
Australia
Phone 70179 0
+61 7 31385956
Fax 70179 0
Email 70179 0
[email protected]
Contact person for scientific queries
Name 70180 0
Margaret MacAndrew
Address 70180 0
QUT
Victoria Park Rd
Level 3 N Block
Kelvin Grove, Qld 4059
Country 70180 0
Australia
Phone 70180 0
+61 7 31385956
Fax 70180 0
Email 70180 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

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