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Trial registered on ANZCTR

Registration number

ACTRN12617000007336

Ethics application status

Approved

Date submitted

10/11/2016

Date registered

3/01/2017

Date last updated

3/01/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

A supervised walking program to reduce risky wandering in people with severe dementia in residential aged care: A feasibility study

Scientific title

A supervised walking program to reduce risky wandering in people with severe dementia in residential aged care: A feasibility study

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1189-6932

Trial acronym

Linked study record

Health condition

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

dementia

Wandering

Condition category

Condition code

Neurological

Alzheimer's disease

Neurological

Dementias

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be taken for a walk by a care staff member or research assistant. Both received 2 hours of training from the principle investigator covering the intervention protocol and acceptable communication styles to be used while walking with participants. Communication style was limited to prescriptive, informative and supportive language to minimise the potential of confounding results with social communication. At the end of the training session the participating care staff and research assistant completed a quiz to assess understanding of communication styles with > 98% accuracy. The intervention protocol involved taking the participating person with dementia on a 30 minute walk, 30 minutes before their unique peak activity period, 5 days per week (Mon-Fri) for 3 weeks. The walk will be on a predetermined route either within the secure facility or outside the secure facility dependent upon care needs. To measure protocol fidelity, the person leading the walk completed a checklist of essential protocol items (pre walk checklist (asked to go for walk, wearing appropriate clothing, elimination needs attended to, offered a drink), time walk started, duration of walk, route taken, and comments about deviations from protocol). 10% of all interventions were observed by the principle investigator or project manager for inter rater reliability and to monitor communication styles.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Number of walks completed - recorded on fidelity check list completed at the end of each supervised walk by the person supervising the walk

Timepoint [1]

Checklist was completed at the end of each supervised walk

Primary outcome [2]

Congruence with intervention protocol

Timepoint [2]

Checklist completed at the end of each supervised walk and checked by a second observer for 10% of all walks

Secondary outcome [1]

Composite secondary outcome
Wandering characteristics - steps taken (Actigraph data), Frequency and duration of intrusion of private space (direct observation), type of pattern (lapping, pacing, random, direct) of ambulation (direct observation)

Timepoint [1]

Pre (week 1), during (weeks 2-4) and post (week 5) intervention measures - 2 x 2hours / person / week
10% of all observations are checked by a second observer for IRR

Secondary outcome [2]

Agitation - Cohen-Mansfield Agitation Inventory

Timepoint [2]

Baseline (1 week before intervention), weeks 1-3 of the 3 week intervention, and a week after the 3 week intervention period

Secondary outcome [3]

Sleep using General Sleep Scale

Timepoint [3]

Baseline (1 week before intervention), weeks 1-3 of the 3 week intervention, and a week after the 3 week intervention period

Secondary outcome [4]

Quality of Life using QoL-AD proxy report

Timepoint [4]

Baseline (1 week before intervention), weeks 1-3 of the 3 week intervention, and a week after the 3 week intervention period

Secondary outcome [5]

Falls as reported in facility incident reporting system

Timepoint [5]

3 months before intervention commencement, weeks 1-3 of the 3 week intervention, and a week after the 3 week intervention period

Secondary outcome [6]

weight

Timepoint [6]

weekly weight collected at baseline (1 week before intervention), weeks 1-3 of the 3 week intervention, and a week after the 3 week intervention period

Eligibility

Key inclusion criteria

>65 years
Severe dementia as documented in medical file and confirmed using Modified Mini Mental State Exam
Independently ambulant (wheelie walker and walking stick acceptable)
Not acutely mentally ill
Positive wandering history as reported by care staff and confirmed using the Revised Algase Wandering Scale

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

<65 year
Not severe dementia
Not independently ambulant

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Pre and post measures to examine impact of intervention on outcome measures

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Repeated measures ANOVA

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/10/2015

Date of last participant enrolment

Anticipated

Actual

30/04/2016

Date of last data collection

Anticipated

Actual

31/07/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4022 - Rothwell

Recruitment postcode(s) [2]

4020 - Scarborough

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Dementia Collaborative Research Centre

Address [1]

QUT
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 Human Research Ethics Committee

Ethics committee address [1]

Victoria Park Rd
Kelvin Grove, Qld, 4059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2015

Approval date [1]

23/07/2015

Ethics approval number [1]

1500000422

Summary

Brief summary

Dementia-related wandering is very common and has been observed in 100% of ambulant people with dementia in RAC (Algase, Kupferschmid, Beel-Bates, & Beattie, 1997). Anecdotal evidence suggests that, when wandering occurs within safe limits, some benefits may be experienced such as physical activity, stimulation, the provision of meaningful activity and improved quality of life (J Dewing, 2006; Martino-Salzman, Blasch, Morris, & McNeal, 1991). However, evidence suggests that when wandering goes beyond safe limits, adverse outcomes for the person who wanders can be experienced (malnutrition and dehydration, sleep deprivation, increased potential for injury from falls and resident to resident violence, becoming lost, and death) (Algase, Beattie, & Son, 2004). For the person with dementia being cared for in RAC, unique problems associated with wandering are experienced. In the RAC setting the person with dementia who wanders can enter out of bounds areas, such as the bedroom of another resident, which can result in loss of privacy. Due to cognitive impairment, the person with dementia who has had their privacy invaded by a person who wanders may respond to the invasion with verbal and physical abuse, which exposes the person who wanders and their co-resident to increased risk of harm (Shinoda-Tagawa et al., 2004; Talerico, Evans, & Strumpf, 2002). The aspect of wandering resulting in these outcomes is known as boundary transgression (BT), defined as a dimension of wandering that takes the person who wanders to out of bounds or hazardous areas. InRAC when wandering takes the person with dementia into the private space of a co-resident, wandering could result in resident to resident violence, loss of privacy and increased agitation for the recipient of the intrusion, and social isolation for the person who wanders (MacAndrew, 2014). Staff and family members also reported that from their experience, wandering-related BT was very common in RAC, was difficult to manage as carers could not predict where and when a BT would occur and if it would be disruptive to others, and often resulted in physical and verbal abuse. Despite the known asdverse outcomes of wandering in RAC, in the absence of RCTs, there is not strong evidence to support the effectiveness of  interventions, and there remains a dearth of evidence-based guidelines for the management of wandering in RAC .
The aims of this pilot study are, in people with dementia living in residential aged care, to explore
1. the feasibility of using a supervised walking program delivered before peak ambulation periods
2. to examine if taking a person with severe dementia who wanders for a daily 30 minute walk for 3 weeks will:
	a. Reduce risky wandering including boundary transgression (BT); 
	b. Improve quality of life (QoL), and sleep quality;
	c. Reduce agitation, falls and weight loss.  
A quasi-experimental study design will be used

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Margaret MacAndrew

Address

QUT
Victoria Park Rd
Kelvin Grove, Qld, 4059

Country

Australia

Phone

+61 7 3138 5956

Fax

[email protected]

Contact person for public queries

Name

Margaret MacAndrew

Address

QUT
Victoria Park Rd
Kelvin Grove, Qld, 4059

Country

Australia

Phone

+61 7 3138 5956

Fax

[email protected]

Contact person for scientific queries

Name

Margaret MacAndrew

Address

QUT
Victoria Park Rd
Kelvin Grove, Qld, 4059

Country

Australia

Phone

+61 7 3138 5956

Fax

[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.

Trial Review

Documents added manually

Documents added automatically