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Trial registered on ANZCTR


Registration number
ACTRN12613000796785
Ethics application status
Approved
Date submitted
15/07/2013
Date registered
16/07/2013
Date last updated
14/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Altering the Rehabilitation Environment to Improve Stroke Survivor Activity (AREISSA): A Phase II Trial
Scientific title
Altering the Rehabilitation Environment to Improve Stroke Survivor Activity (AREISSA): A Phase II Trial-Feasibility and Safety
Secondary ID [1] 282816 0
Nil
Universal Trial Number (UTN)
Trial acronym
AREISSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 289598 0
Condition category
Condition code
Stroke 289931 289931 0 0
Ischaemic
Stroke 289932 289932 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 289933 289933 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Before After Controlled Trial which will compare the activity levels of stroke patients with and without exposure to Environmental Enrichment (EE). EE will involve increased access to activities and equipment which facilitate physical, cognitive and social activities during rehabilitation from stroke in a hospital setting.
Before Phase (standard care) – in this period, participants will receive standard rehabilitation therapies within the standard rehabilitation environment for that particular rehabilitation unit.

The Before Phase is estimated to last for approximately 9 months or until 26 patients have been recruited to complete the intervention cohort. After the last participant in this phase has been discharged from the rehabilitation unit, the Implementation Phase will begin.

Implementation Phase- during this phase the participating rehabilitation unit will no longer recruit patients. They will be provided with the AREISSA Protocol for enrichment and Environmental Enrichment equipment. The Protocol and equipment aims to encourage patients to engage in physical, cognitive and social activity during non-therapy times throughout their entire waking hours. Accompanying this Protocol and enrichment equipment will be an Implementation package and support from the research team as outlined in the below After Phase section. The Implementation Phase will last for approximately 3 months. The time allocated to enhance embedding of this intervention in a busy rehabilitation unit.The After (intervention)Phase will begin at the end of this 3 months.

After Phase (intervention-Environmental Enrichment) – in this period, all participants will have access to both individual and communal forms of Environmental Enrichment for the duration of their stay in the rehabilitation unit. In addition to standard rehabilitation therapies delivered on the unit, participants will be given access to a communal enrichment area which will include computer with internet connection, reading material (fiction and non-fiction books, coffee table books, newspapers), jigsaw puzzles, board games and a dining area for eating meals. Individual enrichment will involve the provision of activities of the participant’s choice including music, audio books, books, word and number puzzles and board games. Family members of participants will be encouraged to bring in hobbies and activities that participants enjoyed prior to their stroke. Participants will have explained the benefits of undertaking activity after stroke and will be advised of daily targets to aim for.

Rehabilitation team members will be advised to encourage participants to attend the communal enrichment area or make use of their individual enrichment activities which will be available in satchels located at their bedside. Additionally, team members will be advised to encourage the participants to utilise the enrichment activities provided to them if the participant is seen to be inactive. At no stage will the participants be coerced into utilising the enrichment equipment and activities. They will be used at the discretion of the participants.

In both the Before (control) and After (intervention) phase, patients will be advised they are in a study investigating the effect that the surrounding environment has on stroke survivor recovery. There will be no mention of ‘environmental enrichment’. The After Phase will similarly last for 9 months or until 26 patients have been recruited to complete the intervention cohort.

Implementation
While the Environmental Enrichment model is largely patient driven, clinicians must support the change in the unit and provide patients with assistance when needed. Targeted implementation strategies will be used to help embed the intervention within the unit. Staff will be supported to promote the EE activities using the following evidence-based strategies: (i) education (ii) Enrichment Champions (iii) audit and feedback and (iv) site support (visits from the Trial Coordinator and regular phone and email contact).

Intervention code [1] 287501 0
Rehabilitation
Comparator / control treatment
Rehabilitation within a non-enriched (standard) environment.
Control group
Active

Outcomes
Primary outcome [1] 289987 0
Activity level : Percentage of the day stroke survivors spend engaged in activity (which includes physical, cognitive and or social activity) will be measured using behavioural mapping.
The primary outcome of activity will be determined using direct observation (via behavioural mapping).
As no instrumented methods of measuring physical, social and cognitive activity exist, it provides the only way to measure activity in this trial.
Behavioural mapping employs structured observation at 10 minute intervals to determine counts of pre-defined physical, cognitive and social activity undertaken by patients, in this trial throughout a 12 hour day.
The equipment in use and/or the activities undertaken by a patient will be recorded, together with the location of activity and the people present.
Trained Activity Assessors, blind to trial design and study objective will map patient activity. To preserve blinding, different assessors will be used in the ‘before’ and ‘after’ periods.
Timepoint [1] 289987 0
10 +/- 2 days following admission to the rehabilitation unit.
Secondary outcome [1] 303719 0
Feasibility: Average percentage of adherence to AREISSA Protocol will be measured weekly from protocol check lists completed by representatives from the participating units and then submitted to the trial office.
Timepoint [1] 303719 0
End of the before phase, end of the after phase
Secondary outcome [2] 303720 0
Safety of the model of EE (risk of adverse events).

All serious adverse events will be extracted from the medical record by a blinded assessor and recorded on a standardised form. Standard definitions will apply.

Examples of an adverse event will include:
fall with no soft tissue injury
fall with soft tissue injury
depression
anxiety
overuse injury
Timepoint [2] 303720 0
90 days post stroke
Secondary outcome [3] 303727 0
Tertiary outcomes: Recovery 90 days post stroke

Freedom from significant disability, calculated as a modified Rankin Scale (mRS) of less than 2. The mRS is valid and reliable measure of global disability commonly used to evaluate the effectiveness of stroke recovery therapies .
Timepoint [3] 303727 0
90 days post stroke
Secondary outcome [4] 303733 0
Rivermead Mobility Index (RMI) to measure level of physical function of participants.
Timepoint [4] 303733 0
90 days post stroke
Secondary outcome [5] 303734 0
Cognitive function as quantified using the brief but reliable cognitive screening tool the Montreal Cognitive Assessment (MoCA).
Timepoint [5] 303734 0
90 days post stroke
Secondary outcome [6] 303735 0
Hospital Anxiety and Depression Scale (HADS) to determine the mood state of participating stroke survivors. The HADS is comprised of questions estimating anxiety and depression and has been shown to be both reliable and valid for use in stroke survivors.
Timepoint [6] 303735 0
90 days post stroke
Secondary outcome [7] 303736 0
Health related quality of life (HRQoL), measured with the Assessment of Quality of Life (AQoL), which has also been shown to be reliable and valid tool in stroke survivors.
Timepoint [7] 303736 0
90 days post stroke
Secondary outcome [8] 303737 0
Self-efficacy will be assessed using the Stroke Self Efficacy Questionnaire to determine a persons’ perceived ability to drive their own enrichment.
Timepoint [8] 303737 0
90 days post stroke
Secondary outcome [9] 303738 0
Activity participation in the community setting will be assessed using the Activity Card Sort which has been validated for use in the elderly population.
Timepoint [9] 303738 0
90 days post stroke
Secondary outcome [10] 306539 0
Patient experience (of undergoing in-patient stroke rehabilitation within a standard rehabilitation unit environment vs within an enriched environment) will be collected using in-depth individual interviews.
Timepoint [10] 306539 0
Within 2 weeks post-discharge from inpatient rehabilitation.
Secondary outcome [11] 306540 0
Staff experience of working with stroke patients undergoing inpatient rehabilitation within a standard rehabilitation environment vs an enriched environment) using in-depth individual interviews.
Timepoint [11] 306540 0
Any time point during the before (control) phase and any time during the after (intervention) phase.

Eligibility
Key inclusion criteria
All patients with confirmed stroke of less than 4 weeks with a pre-morbid modified Rankin Scale (mRS1) score less than or equal to 2 (minimal/no disability) admitted for rehabilitation who are able to stand with the assistance of two people or less, can follow a one stage command and have a predicted estimated length of stay of greater than or equal to 14 days, will be eligible for inclusion.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients diagnosed with pre-existing dementia or any other deteriorating medical condition will be excluded.

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)
We will include people greater than or equal to 18 years of age who have been admitted to a rehabilitation unit for inpatient stroke rehabilitation in Australia. All patients admitted for stroke rehabilitation will be screened for eligibility using a standardised checklist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Before After Controlled Trial.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation

Based on results from our pilot study17, in which stroke patients exposed to EE were 1.2 (95%CI 1.0 to 1.4) times more likely to be engaged in activity, we hypothesise that the activity levels of patients undergoing stroke rehabilitation with EE will be 20% greater than those in the non-enriched rehabilitation period. Available data suggests an increase in activity of this magnitude during the critical recovery window is also likely to result in clinically meaningful improvements in functional outcome. Using the variability observed in our pilot trial and assuming standard settings of two-sided significance a = 0.05, a total of 208 patients, 104 patients per group (i.e. 26 control and 26 intervention patients per unit, n=4) will yield 80% power to detect 6% or greater difference in patient activity between EE exposed and non-exposed patient cohorts (mean1=0.5, mean2=0.56, SD1(0.14) SD2(0.165)). Although the magnitude of the benefit is expected to be around 20%, the trial has power to detect smaller effects of at least 6%. This extra power is built into the design to account for present uncertainty in Intraclass Correlation Coefficient (at 20% effect difference this sample size provides enough power to detect the clustering design effect of up to 11 (ICC up to 0.4)). It also provides higher power to observe meaningful changes in secondary and tertiary outcomes.


Statistical Analyses
Primary outcome
The difference between the control and intervention groups in percentage of the day participants spend in activity at day 10 (+/-2) following admission to the rehabilitation unit, adjusted for age and stroke severity (NIHSS) at the baseline, will be estimated using a multi-level (hierarchical) random-effect linear regression model with the group, age, and NIHSS score as independent variables and treating rehabilitation unit as a level variable.

Secondary and tertiary outcomes
The difference between the groups in the outcomes for safety and freedom from significant disability at 90 days adjusted for age and stroke severity at the baseline will be estimated using appropriate multi-level (hierarchical) random-effect regression models with the group, age, and NIHSS score as an independent variables and treating unit as a level variable, as follows:
*The rate of falls (falls per bed day) and rate of adverse events - Poisson or Negative Binomial regression model (participant to distributional assumptions)
*Freedom from significant disability at 90 days (mRS0-2) – logistic regression model.

Analysis of other tertiary outcomes (physical function (RMI), cognitive function (MoCA), mood (HADS) quality of life (AQoL)), as well as the estimation of corresponding Intraclass Correlation Coefficients for all outcomes, will be conducted using appropriate multi-level (hierarchical) random-effect regression models with the group, age, and NIHSS score as an independent variable and treating unit as a level variable.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 1993 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 1994 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 1995 0
Kingston Centre - Cheltenham

Funding & Sponsors
Funding source category [1] 287598 0
Other
Name [1] 287598 0
Hunter Medical Research Institute
Address [1] 287598 0
Lot 1 Kookaburra Crt
New Lambton Heights
NSW, 2305
Country [1] 287598 0
Australia
Funding source category [2] 287599 0
Charities/Societies/Foundations
Name [2] 287599 0
John Hunter Hospital Charitable Trust Foundation
Address [2] 287599 0
John Hunter Hospital Campus, Lookout Rd, New Lambton Heights,
NSW 2305
Country [2] 287599 0
Australia
Funding source category [3] 288598 0
Charities/Societies/Foundations
Name [3] 288598 0
National Heart Foundation- NSW Cardiovascular Research Network
Address [3] 288598 0
Level 3, 80 William Street
East Sydney NSW 2011
Country [3] 288598 0
Australia
Primary sponsor type
Other
Name
Hunter Medical Research Institute
Address
Lot 1 Kookaburra Crt
New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 286347 0
University
Name [1] 286347 0
The University of Melbourne
Address [1] 286347 0
Grattan St
Parkville, VIC, 3010
Country [1] 286347 0
Australia
Other collaborator category [1] 277523 0
University
Name [1] 277523 0
University of Newcastle
Address [1] 277523 0
University Drive
Callaghan , NSW, 2308
Country [1] 277523 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289574 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 289574 0
John Hunter Hospital Campus,
Lookout Rd
New Lambton Heights
NSW, 2305
Ethics committee country [1] 289574 0
Australia
Date submitted for ethics approval [1] 289574 0
31/07/2013
Approval date [1] 289574 0
15/10/2013
Ethics approval number [1] 289574 0
13/0918/4.06

Summary
Brief summary
Despite higher levels of activity being associated with better stroke recovery, stroke patients on most rehabilitation units spend the majority of their day inactive and alone. In animal models, Environmental Enrichment (EE) involves organisation of the environment and provision of equipment to facilitate physical, cognitive and social activity. EE promotes rewiring of the brain after stroke and has been found to significantly enhance functional recovery. Preliminary work on the use of a human model of EE using individual (eg. iPods, & word puzzles) and communal (eg. access to interactive gaming, computer, books/newspapers & jigsaws) enrichment in a rehabilitation unit indicates it encourages stroke patients to be more active. Greater activity during rehabilitation has numerous benefits, the most important of which is achieving better functional recovery and subsequently, greater independence. Altering the Rehabilitation Environment to Improve Stroke Survivor Activity (AREISSA) is a Phase II Trial involving four rehabilitation units which seeks to determine the safety, efficacy, feasibility and patient and staff acceptability of this model of EE during stroke rehabilitation.
We hypothisize that compared to stroke patients undergoing rehabilitation in non-enriched environments, patients recovering in EE will:
(i) be more active at 10 days (+/- 2) post admission, and that the guidelines which accompany the EE will:
(ii) be adhered to by staff, and
(iii) not result in a significant increase in falls or other adverse events.
Results from AREISSA will be used to inform future larger trials required to determine the effect of EE on stroke recovery and stroke survivor quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41378 0
Dr Neil Spratt
Address 41378 0
Department of Neurology, John Hunter Hospital,
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 41378 0
Australia
Phone 41378 0
+61 2 49216171
Fax 41378 0
+61 2 49217406
Email 41378 0
neil.spratt@hnehealth.nsw.gov.au
Contact person for public queries
Name 41379 0
Ms Heidi Janssen
Address 41379 0
Hunter Medical Research Institute

Stroke Research Team Level 3 East

Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305

Country 41379 0
Australia
Phone 41379 0
+61 2 40420417
Fax 41379 0
Email 41379 0
heidi.janssen@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 41380 0
Dr Neil Spratt
Address 41380 0
Department of Neurology, John Hunter Hospital,
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 41380 0
Australia
Phone 41380 0
+61 2 49 216171
Fax 41380 0
Email 41380 0
neil.spratt@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary