Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000212550
Ethics application status
Approved
Date submitted
20/02/2015
Date registered
5/03/2015
Date last updated
18/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Exterior Interior
Can pseudo-natural environments, produced through video projections, improve dementia related symptoms and behaviours?
Scientific title
Effects of pseudo-natural environments on agitation, depression, sleep quality and well-being in individuals with dementia.
Secondary ID [1] 286018 0
Nil
Universal Trial Number (UTN)
U1111-1166-2335
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioural Disturbances 293981 0
Depression 293982 0
Circadian Rhythmicity / Sleep Disturbances 293983 0
Dementia 294345 0
Condition category
Condition code
Mental Health 294281 294281 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 294282 294282 0 0
Dementias
Mental Health 294283 294283 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventional phase (Control B) delivers a projection of recorded exterior natural environments (3 total) in an interior context to create an immersive (sight and sound) experience of nature. Participants will view all three variations of the natural environments throughout each Arm of the intervention phase, which will be completed over a 12 week period. An incremental approach has been applied to the length of intervention exposure with each Arm of the intervention phase (Control B). The environments will be taken from 3 contexts - Australian bush, Ocean/Beach, Animals in nature.

Arm 1 (Week 12-15)
Each participant (individually) will watch 5 minutes of any of the 3 potential natural environment projections with a care worker (2x per week) for a period of three weeks.

Arm 2 (Week 15-18)
Each participant (individually) will watch 10 minutes of any of the 3 potential natural environment projections with a care worker (2x per week) for a period of three weeks.

Arm 3 (Week 18-21)
Each participant (individually) will watch 15 minutes of any of the 3 potential natural environment projections with a care worker (2x per week) for a period of three weeks.

Arm 4 (Week 21-24)
Each participant (individually) will watch 20 minutes of any of the 3 potential natural environment projections with a care worker (2x per week) for a period of three weeks.

The researcher will unobtrusively collect timing and observational information relating to participant responses to each intervention throughout the study. This information will identify the preferred natural environment for each participant and the group collectively.
Intervention code [1] 290996 0
Treatment: Other
Intervention code [2] 290997 0
Behaviour
Intervention code [3] 290998 0
Lifestyle
Comparator / control treatment
The pre-intervention (no treatment) phase provides baseline data of specific dementia behaviours and symptoms, over a period of 12 weeks. This pre-intervention phase (Control A) creates a comparator for analysis whereby the intervention (active control) participants become their own control condition. During the 12 weeks post-intervention (no treatment) phase (Control C) participants remain monitored and data collection activities continue.

Control A monitors participant agitation for a 12 week period using the Cohen-Mansfield Agitation Inventory (Long Form) with assessments undertaken by suitably trained care staff at (baseline) week 0, 3, 6, 9 and 12.

Control C monitors participant agitation for a 12 week period using the Cohen-Mansfield Agitation Inventory (Long Form) with assessments undertaken by suitably trained care staff at (baseline) week 36, 39, 42, 45 and 48.
Control group
Active

Outcomes
Primary outcome [1] 294075 0
Changes in type and frequency of behaviours measured using the Cohen-Mansfield Agitation Inventory (Long Form) [CMAI]
Timepoint [1] 294075 0
From baseline and every 3 weeks prior to intervention commencement (week 3, 6, 9 and 12), during intervention (week 15, 18, 21 and 24) and post intervention cessation (week 27, 30 and 33). Total of 11 measurement points.
Primary outcome [2] 294076 0
Mean Pittsburgh Sleep Quality Index [PSQI] score
Timepoint [2] 294076 0
From baseline and every 12 weeks (week 0, 12, 24, 36). Total of 4 measurement points.
Primary outcome [3] 294077 0
Mean Cornell Scale for Depression in Dementia [CSDD] score
Timepoint [3] 294077 0
From baseline and every 12 weeks (week 0, 12, 24, 36). Total of 4 measurement points.
Secondary outcome [1] 312477 0
Mean incidence of physical and pharmacological restrain use assessed through Clinical Notes.
Timepoint [1] 312477 0
Weekly from baseline (week 0) to (week 36). Total of 37 measurement points.
Secondary outcome [2] 312478 0
Mean incidence of falls assessed through Clinical Notes.
Timepoint [2] 312478 0
Weekly from baseline (week 0) to (week 36). Total of 37 measurement points.
Secondary outcome [3] 312479 0
Mean incidence of sundown syndrome behaviours assessed through Clinical Notes.
Timepoint [3] 312479 0
Weekly from baseline (week 0) to (week 36). Total of 37 measurement points.
Secondary outcome [4] 312480 0
Mean incidence of social interaction assessed through Clinical Notes.
Timepoint [4] 312480 0
Weekly from baseline (week 0) to (week 36). Total of 37 measurement points.

Eligibility
Key inclusion criteria
Individuals residing in an institutional care facility within the metropolitan area of Perth, Western Australia.

Individuals with a confirmed dementia diagnosis.

Individuals with active behavioural symptoms (assessed using the Cohen-Mansfield Agitation Inventory) with a frequency score of 4 (weekly) in at least two items of the CMAI or a total score greater than 45.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are significantly visually impaired.

Individuals who have a medically diagnosed sleep breathing disorder (sleep apnoea).

Individuals who have a seizure disorder.

Study design
Purpose of the study
Treatment
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
Other
Other design features
The single group of participants act as their own control condition through monitoring pre-post study. Participants will receive all three variations of the intervention throughout each intervention Arm(x4).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We are planning a study of a continuous response variable (Cohen-Mansfield Agitation Inventory) scale from matched pairs of study subjects (Pre-Post study). Prior data indicate that the difference in the response of matched pairs is normally distributed with standard deviation 20. If the true difference in the mean response of matched pairs is 8 (delta), we will need to study 51 pairs (sample size) of subjects to be able to reject the null hypothesis that this response difference is zero with probability (power) 80%. The Type I error probability associated with this test of this null hypothesis is alpha=0.05.

Clinical significance is arguably most pertinent when considering the most disruptive of dementia behaviours. Therefore a change in rated frequency from several times a day to several times a week, for the sub-scales of Aggressive behaviour and Verbally Agitated behaviour of the Cohen-Mansfield Agitation Inventory (Long Form with expanded definitions), would be indisputably clinically significant. Therefore a reduction in scores from baseline to post-intervention of at least 8 points would be regarded clinically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2016
Actual
Date of last participant enrolment
Anticipated
1/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 9133 0
6000 - Perth
Recruitment postcode(s) [2] 13090 0
6102 - Bentley South

Funding & Sponsors
Funding source category [1] 290610 0
Self funded/Unfunded
Name [1] 290610 0
Ms Shaye Starr
Country [1] 290610 0
Australia
Primary sponsor type
Individual
Name
Associate Professor, Dr Dianne Smith
Address
Department of Architecture and Interior Architecture
School of Built Environment
Curtin University
GPO Box U1987
Perth
Western Australia 6845
Country
Australia
Secondary sponsor category [1] 289297 0
Individual
Name [1] 289297 0
Ms Shaye Starr
Address [1] 289297 0
Curtin University
PO Box 3168
Carlisle South
Western Australia 6101
Country [1] 289297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292242 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 292242 0
Ethics committee country [1] 292242 0
Australia
Date submitted for ethics approval [1] 292242 0
21/11/2014
Approval date [1] 292242 0
16/04/2015
Ethics approval number [1] 292242 0
HR70/2015

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

Contacts
Principal investigator
Name 54266 0
Ms Shaye Starr
Address 54266 0
Curtin University
PO Box 3168
Carlisle South
Western Australia 6101
Country 54266 0
Australia
Phone 54266 0
+61 433 686 969
Fax 54266 0
Email 54266 0
[email protected]
Contact person for public queries
Name 54267 0
Shaye Starr
Address 54267 0
Curtin University
PO Box 3168
Carlisle South
Western Australia 6101
Country 54267 0
Australia
Phone 54267 0
+61 433 686 969
Fax 54267 0
Email 54267 0
[email protected]
Contact person for scientific queries
Name 54268 0
Shaye Starr
Address 54268 0
Curtin University
PO Box 3168
Carlisle South
Western Australia 6101
Country 54268 0
Australia
Phone 54268 0
+61 433 686 969
Fax 54268 0
Email 54268 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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