Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000679684
Ethics application status
Approved
Date submitted
10/06/2014
Date registered
26/06/2014
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of creating an enriched environment and subsequent impact on activity levels for stroke patients in an Acute Stroke Unit.
Scientific title
The effect of an enriched environment on activity levels compared to usual care in people admitted to an Acute Stroke Unit with a diagnosis of stroke.
Secondary ID [1] 284774 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
EESI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Stroke 292146 0
Condition category
Condition code
Stroke 292477 292477 0 0
Ischaemic
Stroke 292478 292478 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 292563 292563 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a study to determine if it is feasible to create an enriched environment in an Acute Stroke Unit and if it will increase patient activity in the Acute Stroke Unit. The study involves a prospective non-randomized quasi-experimental block design with 30 people with stroke recruited to the usual care group (block 1) and 30 people with stroke recruited to the enriched environment group (block 2). Each block is estimated to last for 12 weeks. No change in staffing levels will occur during the study.

In the usual care group, usual assessment and management of people with stroke admitted to the Acute Stroke Unit will occur.

In the enriched environment group, the physical and social environment of the Acute Stroke Unit will change to promote greater physical, social and cognitive activity. This will include a mix of individual and group therapies. Group activities will be organized to focus on different factors of stroke recovery e.g. education, emotional support, physical activities and leisure activities.

Communal areas will be created e.g., patients can have breakfast and lunch in the treatment room together with other patients under staff supervision. Different types of equipment will be available to stimulate physical, cognitive and social activity e.g., iPads, iPods, books, games, puzzles, music. Equipment will be accessible during and outside of therapy hours. Staff members will re- organise their work routine to facilitate patient activity during the day.

The enriched environment design requires being flexible from a day-to-day basis due to a fast changing patient population in the Acute Stroke Unit. A flexible week schedule with approximate 3 defined activity periods for 1 hour will be scheduled from Monday till Friday to organize and structure the enriched environment.

All patients and their visitors enrolled in the experimental group (second block) will be informed that activity after stroke enhances stroke recovery and they will be encouraged to utilize communal areas and materials to facilitate activity. Family will be asked to bring the patients own clothing and items of interest to contribute to patient activity. Staff members from the Acute Stroke Unit will stimulate patients to attend the communal areas and to utilize the materials to increase their activity level during the day. Patients, visitors and staff will be advised to respect the 1-hour rest time period after lunch.

To minimize risk and monitor for adverse events, blood pressure and temperature observations of patients will be performed 4 times a day. Two of the four time periods will always occur at 7.00 AM and 14.00 PM to ensure safety before peak activity levels. If SBP is greater than or equal to 200 and/ or Temperature greater than or equal to 38 degrees the subsequent activity period will be missed. After the missed period, blood pressure and temperature measurements will be repeated. When measurements are within safe limits the patient can continue to participate with the activities. When measurements are not within safe limits the patient will miss the subsequent activity period.
Intervention code [1] 289564 0
Treatment: Other
Intervention code [2] 289565 0
Rehabilitation
Comparator / control treatment
Standard care in an Acute Stroke Unit
Control group
Active

Outcomes
Primary outcome [1] 292345 0
Activity levels: Percentage of the day the patient is engaged in physical, social and cognitive activity. This will be collected through direct observation using behavioral mapping. Trained staff will observe the participant for 1 minute and will document the main activity performed during this minute. Staff will also document the type of activity, level of assistance required, location, positioning and all people who are present.
Timepoint [1] 292345 0
Behavioral mapping will commence the first behavioral mapping day after the patient is recruited to the study and continued until discharged from the Acute Stroke Unit. Behavioral mapping will occur every Tuesday, Thursday and Saturday from 7.30am till 7.30pm during each block.
Secondary outcome [1] 308737 0
Stroke survivor, main carer and clinical staff experience
In both blocks the participant and main carer will complete a survey designed specifically for this study to capture their service experience at discharge from the Acute Stroke Unit. Clinical staff will also be asked to participate in a staff survey specifically designed for this study when the standard care cohort is in week 6, and in week 6 in the enriched environment design.
Timepoint [1] 308737 0
Patient and main carer survey at discharge from the Acute Stroke Unit. Staff surveys when standard care cohort is in week 6, and when enriched environment cohort is in week 6.
Secondary outcome [2] 308738 0
Secondary complications will be defined as any adverse event or serious adverse event occurring during their admission to the Acute Stroke Unit. Adverse events that will be recorded are falls, pneumonia, pressure areas, cardiac problems, seizures, reduced GCS, stroke, TIA, urinary tract infection, depression, constipation and malnutrition. Severity of the adverse event and study intervention relationship will be determined.

Serious adverse events will be described as an adverse event that led to death or led to serious deterioration in health of a patient or other that: 1. Results in life threatening illness 2. Results in permanent impairment of a body structure 3. Requires prolonged hospitalisation 4. Results in medical or surgical intervention to prevent permanent impairment.
Timepoint [2] 308738 0
Adverse events and serious adverse events reported during the time the patient is admitted in the Acute Stroke Unit will be recorded. Serious adverse events will also be recorded at three months post stroke via telephone.
Secondary outcome [3] 308739 0
Functional outcomes
Mean Modified Rankin Scale scores.
Timepoint [3] 308739 0
Initial and at discharge from the Acute Stroke Unit. The MRS will also be completed at three months post stroke via telephone interview.
Secondary outcome [4] 308740 0
Functional outcome
Mean Modified Barthel Index.
Timepoint [4] 308740 0
Initial and at discharge from the Acute Stroke Unit.
Secondary outcome [5] 308741 0
Ambulatory function
Score on the Mobility Scale for Acute Stroke patients.
Timepoint [5] 308741 0
Initial and at discharge from the Acute Stroke Unit
Secondary outcome [6] 308742 0
Ambulatory function
Time to complete the 10-meter walk test.
Timepoint [6] 308742 0
Initial and at discharge from the Acute Stroke Unit.
Secondary outcome [7] 308743 0
Depression and anxiety
Mean score on the Hospital Anxiety and Depression Scale
Timepoint [7] 308743 0
Initial and discharge from the Acute Stroke Unit.
Secondary outcome [8] 308912 0
Nutritional intake
Mean percentage nutritional intake.
Consumed percentage of breakfast, lunch and dinner will be recorded during daily audits. All other nutritional intake will be recorded on food charts and accordingly calculated.
Timepoint [8] 308912 0
Food Audit and food charts starts the day after recruitment and will be performed from Monday through to Saturday till the patient gets discharged from the Acute Stroke Unit.
Secondary outcome [9] 308913 0
Nutritional intake
Mean weight.
Timepoint [9] 308913 0
The participants weight will be measured during initial and discharge assessment and routinely on Thursdays and Sundays.
Secondary outcome [10] 308914 0
Living arrangement
During the three months post stroke telephone interview the living arrangement will be determined.
Timepoint [10] 308914 0
3 months post stroke.
Secondary outcome [11] 308915 0
Health State Score
During the three months post stroke telephone interview the Health State Score will be determined.
Timepoint [11] 308915 0
3 months post stroke.

Eligibility
Key inclusion criteria
Adults who are 1) admitted to the Acute Stroke Unit with the diagnosis of a stroke (ischaemic and haemorrhagic) within 24-72 hours after onset, 2) able to complete a transfer with the assistance of 2 persons or less, 3) able to follow one stage commands, 4) requires assistance for basic ADL’s, 5) premorbid MRS 2 or less and able to walk independently.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient diagnosed with a rapid deteriorating health condition and/or with an active and uncontrolled mental health condition.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
Prospective quasi-experimental design. Participants are allocated by block, as the intervention is a change to the hospital environment in one Acute Stroke Unit.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Total activity will be expressed as a percentage of the total number of observations performed, as will activity within domains of physical, social and cognitive activity. The first 14 days of observations will be considered as the primary exposure profile. Difference in measure between the two blocks will be determined using one-way ANCOVA, with covariates including age, stroke severity and premorbid function. Using data of 'any activity' from a recent study of the effect of an enriched environment on activity conducted during inpatient rehabilitation, a sample size calculation determined that with an alpha level of 0.05, 26 participants per group are required to give the trial 80% power to detect a moderate effect size of 0.7.

All secondary outcomes measures will be compared between experimental and control group using ANCOVA, with covariates including age, stroke severity and premorbid function.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/06/2014
Date of last participant enrolment
Anticipated
30/04/2015
Actual
11/06/2015
Date of last data collection
Anticipated
Actual
11/06/2015
Sample size
Target
60
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2613 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 8289 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 289389 0
Charities/Societies/Foundations
Name [1] 289389 0
Wishlist Sunshine Coast Health Foundation; Novice Researcher Grant
Country [1] 289389 0
Australia
Funding source category [2] 289390 0
Government body
Name [2] 289390 0
Allied Health Professions Office; Health Practitioner Research Grant
Country [2] 289390 0
Australia
Funding source category [3] 289391 0
Hospital
Name [3] 289391 0
Allied Health Department, Medical Services, Nambour General Hospital
Country [3] 289391 0
Australia
Funding source category [4] 289392 0
Government body
Name [4] 289392 0
Clinical Practice Improvement Payment; Statewide Stroke Clinical Network, Queensland Health
Country [4] 289392 0
Australia
Primary sponsor type
Individual
Name
Mrs Ingrid Rosbergen
Address
Allied Health Department, Medical Services,
Nambour General Hospital
Hospital Road
Nambour 4560 QLD
Country
Australia
Secondary sponsor category [1] 288075 0
None
Name [1] 288075 0
Address [1] 288075 0
Country [1] 288075 0
Other collaborator category [1] 277996 0
University
Name [1] 277996 0
The University of Queensland;
School of Health and Rehabilitation Sciences
Address [1] 277996 0
Brisbane Qld 4072
Country [1] 277996 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291152 0
Metro North Hospital and Health Service, The Prince Charles Hospital, Human Research Ethics Committee
Ethics committee address [1] 291152 0
Ethics committee country [1] 291152 0
Australia
Date submitted for ethics approval [1] 291152 0
08/02/2014
Approval date [1] 291152 0
05/03/2014
Ethics approval number [1] 291152 0
HREC:14/QPCH/21
Ethics committee name [2] 291153 0
The University Of Queensland, Medical Research Ethics Committee
Ethics committee address [2] 291153 0
Ethics committee country [2] 291153 0
Australia
Date submitted for ethics approval [2] 291153 0
Approval date [2] 291153 0
21/03/2014
Ethics approval number [2] 291153 0
2014000371

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

Contacts
Principal investigator
Name 49114 0
Mrs Ingrid Rosbergen
Address 49114 0
Allied Health Services, Stroke and Neurology
Sunshine Coast University Hospital
6 Doherty Street
Birtinya QLD 4575
Country 49114 0
Australia
Phone 49114 0
+61 7 52028648
Fax 49114 0
Email 49114 0
[email protected]
Contact person for public queries
Name 49115 0
Rohan Grimley
Address 49115 0
Department of Medicine
Sunshine Coast University Hospital
6 Doherty Street
Birtinya QLD 4575
Country 49115 0
Australia
Phone 49115 0
+61 7 53134270
Fax 49115 0
Email 49115 0
[email protected]
Contact person for scientific queries
Name 49116 0
Sandra Brauer
Address 49116 0
The University of Queensland,
School of Health and Rehabilitation Sciences,
Brisbane Qld 4072
Country 49116 0
Australia
Phone 49116 0
+61 7 33652317
Fax 49116 0
Email 49116 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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