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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]

Nil other

Universal Trial Number (UTN)

U1111-1189-5507

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Wandering

Condition category

Condition code

Neurological

Dementias

Neurological

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]

Behaviour

Intervention code [2]

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]

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]

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]

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]

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]

Agitation - Cohen Mansfield Agitation Inventory - Short Form (CMAI-SF)

Timepoint [2]

Baseline (pre intervention - start Week 1), during intervention (Start Weeks 2-4) and post intervention (start week 5).

Secondary outcome [3]

Staff and family perceptions of benefits and acceptability of music program: Composite secondary outcome

Timepoint [3]

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]

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]

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]

Are participants able to listen to music for a period of 20 minutes per day five times per week for 3 weeks?

Timepoint [5]

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]

Do participants enjoy listening to music?

Timepoint [6]

At the end of each listening to music session, participants will be asked if they enjoyed the music session.

Secondary outcome [7]

Immediate pleasure

Timepoint [7]

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]

Reliability of staff to identify residents with dementia who wander and exhibit BT at an intensity that is observable

Timepoint [8]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4022 - Rothwell

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Dementia Collaborative Research Centre

Address [1]

QUT
Level 6 N Block
Victoria Park Rd
Kelvin Grove, Qld 4059

Country [1]

Australia

Primary sponsor type

University

Name

Queensland University of Technology

Address

Victoria Park Rd
Kelvin Grove, Qld 4059

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queensland University of Technology

Ethics committee address [1]

Victoria Park Rd
Kelvin Grove, Qld 4059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/05/2016

Approval date [1]

25/07/2016

Ethics approval number [1]

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

Dr Margaret MacAndrew

Address

QUT
Victoria Park Rd
Level 3 N Block
Kelvin Grove, Qld 4059

Country

Australia

Phone

+61 7 31385956

Fax

margaret.macandrew@qut.edu.au

Contact person for public queries

Name

Margaret MacAndrew

Address

QUT
Victoria Park Rd
Level 3 N Block
Kelvin Grove, Qld 4059

Country

Australia

Phone

+61 7 31385956

Fax

margaret.macandrew@qut.edu.au

Contact person for scientific queries

Name

Margaret MacAndrew

Address

QUT
Victoria Park Rd
Level 3 N Block
Kelvin Grove, Qld 4059

Country

Australia

Phone

+61 7 31385956

Fax

margaret.macandrew@qut.edu.au

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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