Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000238673
Ethics application status
Approved
Date submitted
18/02/2014
Date registered
6/03/2014
Date last updated
6/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quantifying the Physical, Cognitive and Social Activity Levels Early After Stroke: How Enriched is the Acute Stroke Environment?
Scientific title
Quantifying Activity Levels of Survivors Early After Stroke
Secondary ID [1] 283906 0
Nil
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 290904 0
Condition category
Condition code
Stroke 291256 291256 0 0
Ischaemic
Stroke 291552 291552 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational Study- Quantifying activity using direct observation techniques (behavioral mapping). Patients will be observed on a randomly selected weekday every 5 minutes for 55 minutes during each of the following time periods (i) 8-11am, (ii) 11am-2pm, (iii) 2pm-5pm and (iv) 5pm-8pm.
Patients will be observed for one day within the first 21 days following their stroke.
Intervention code [1] 288587 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291253 0
Percentage of the day spent in activity using behavioural mapping techniques on one weekday during their admission within the acute neurology ward/stroke unit, < or = to 21 since their initial stroke. They will be observed on a randomly selected weekday every 5 minutes for 55 minutes during each of the following time periods (i) 8-11am, (ii) 11am-2pm, (iii) 2pm-5pm and (iv) 5pm-8pm.
Timepoint [1] 291253 0
> 2 days and < or = 21 days post stroke
Secondary outcome [1] 306345 0
Experience of stroke patients recovering in acute stroke setting early after stroke using qualitative in -depth interview techniques. They will be interviewed within the first 21 days post stroke and whilst they are still an inpatient within the ward.
Timepoint [1] 306345 0
> 2 days and < or = 21 days post stroke
Secondary outcome [2] 306346 0
Experience of staff working in an acute stroke setting with patients recovering very early after stroke using qualitative in -depth interview techniques.
Timepoint [2] 306346 0
At some stage during the conduct of the observational study. Data collection is expected to be completed by August 2014.

Eligibility
Key inclusion criteria
Admitted for recent stroke
Estimated length of stay > 2 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
premorbid modified Rankin Scale score > or = 3.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Activity, location and people present for each participant will be expressed as a percentage of the total number of observations made. A Pearson product–moment correlation coefficient (r) will be calculated to assess the relationship between activity level and (i) stroke severity (ii) motor function (motor component of NIHSS), (iii) cognitive function (cognitive component of NIHSS), and (iv) mood (HADS). The 95% confidence intervals (CI) for Pearson’s r will be calculated using Fisher’s transformation. All analyses will be performed using STATA 13.0. Qualitative data will be analysed using an inductive thematic approach with the use of constant comparison.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
Date of last participant enrolment
Anticipated
31/07/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2112 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 7804 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 288748 0
Charities/Societies/Foundations
Name [1] 288748 0
National Stroke Foundation
Country [1] 288748 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Stroke Foundation
Address
Level 7, 461 Bourke St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 287443 0
Government body
Name [1] 287443 0
Hunter Stroke Service (Hunter New England Local Health District)
Address [1] 287443 0
Lookout Rd
New Lambton Heights, NSW, 2305
Country [1] 287443 0
Australia
Secondary sponsor category [2] 287444 0
University
Name [2] 287444 0
University of Newcastle
Address [2] 287444 0
University Drive
Callaghan, NSW, 2308
Country [2] 287444 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290587 0
Hunter New England Health Local Health District Human Research Ethics Committee
Ethics committee address [1] 290587 0
Lookout Rd
New Lambton Heights
NSW 2305
Ethics committee country [1] 290587 0
Australia
Date submitted for ethics approval [1] 290587 0
Approval date [1] 290587 0
22/01/2014
Ethics approval number [1] 290587 0
HNEHREC- 13/12/11/5.22, NSW HREC-LNR/13/HNE/546

Summary
Brief summary
Acute stroke patients spend as little as 13% the day in physical activity (1), but how much of their day is spent participating in cognitive and social activities remains unknown. The proposed observational study seeks to determine the: (i) physical, cognitive and social activity levels of patients very early after stroke, (ii) relationship between stroke severity and activity levels, (iii) proportion of acute stroke patients capable of engaging in greater activity and, (iv) barriers and facilitators to activity in an acute neurology unit. This is important preliminary work required to inform the translation of the use of an enriched environment into the acute setting.
Trial website
N/A
Trial related presentations / publications
None at this stage
Public notes

Contacts
Principal investigator
Name 45550 0
Dr Heidi Janssen
Address 45550 0
Hunter Medical Research Institute
Stroke Research Team Level 3 East
Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Country 45550 0
Australia
Phone 45550 0
+61 2 40420417
Fax 45550 0
+61 2 40420033
Email 45550 0
[email protected]
Contact person for public queries
Name 45551 0
Dr Heidi Janssen
Address 45551 0
Hunter Medical Research Institute
Stroke Research Team Level 3 East
Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Country 45551 0
Australia
Phone 45551 0
+61 2 40420417
Fax 45551 0
+61 2 40420033
Email 45551 0
[email protected]
Contact person for scientific queries
Name 45552 0
Dr Heidi Janssen
Address 45552 0
Hunter Medical Research Institute
Stroke Research Team Level 3 East
Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Country 45552 0
Australia
Phone 45552 0
+61 2 40420417
Fax 45552 0
+61 2 40420033
Email 45552 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.