Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000554965
Ethics application status
Approved
Date submitted
25/05/2011
Date registered
31/05/2011
Date last updated
24/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Out-and-About trial: Improving quality of life after stroke
Scientific title
Do rehabilitation teams that receive the Out-and-about program provide more outings to community-based stroke patients over 12 months than rehabilitation teams that receive only clinical guidelines?
Secondary ID [1] 252018 0
None
Universal Trial Number (UTN)
Trial acronym
Out-and-About
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rehabilitation provided by physiotherapists, occupational therapists and therapy assistants in community-based rehabilitation teams to community-based people with stroke. 257503 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257735 257735 0 0
Occupational therapy
Physical Medicine / Rehabilitation 257736 257736 0 0
Physiotherapy
Stroke 257737 257737 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Guidelines + training: Physiotherapists, occupational therapists and therapy assistants in experimental teams will receive a written copy of the National Stroke Foundation's Clinical Guidelines for Stroke Management 2010 to be utilised for the duration of 12 months. In addition, they will attend a half-day workshop and receive education about providing therapy to people after stroke, as well as feedback about team practice from a medical record audit.
Intervention code [1] 256595 0
Behaviour
Intervention code [2] 256659 0
Rehabilitation
Comparator / control treatment
Guidelines only: Physiotherapists, occupational therapists and therapy assistants in control teams will receive a written copy of the National Stroke Foundation's Clinical Guidelines for Stroke Management 2010 only.
Control group
Active

Outcomes
Primary outcome [1] 258566 0
Rehabilitation teams: The proportion of people with stroke receiving four or more outings during therapy. This outcome will be assessed by way of retrospective audits of medical records for clients with stroke (baseline and 12 months).
Timepoint [1] 258566 0
12 months.
Primary outcome [2] 258693 0
Rehabilitation teams: Number of outings delivered to people with stroke by team members, as assessed by retrospective audits of medical records for clients with stroke (baseline and 12 months).
Timepoint [2] 258693 0
12 months
Secondary outcome [1] 264548 0
People with stroke: Number of outings, as measured during waking hours for seven consecutive days by use of a personal Global Positioning Device (GPS) carried or worn by the person with stroke. GPS data will be downloaded via Google Maps.
Timepoint [1] 264548 0
6 months
Secondary outcome [2] 264550 0
People with stroke: Distance travelled outdoors, as measured by data collected from a personal GPS carried or worn by the person with stroke for a consecutive seven day period.
Timepoint [2] 264550 0
6 months
Secondary outcome [3] 264595 0
People with stroke: Nature of outings (i.e., types of places visited, reason for leaving house). This outcome will be assessed by way of a self-report diary kept for seven days.
Timepoint [3] 264595 0
6 months
Secondary outcome [4] 264596 0
People with stroke: Walking capacity, measured by the 6-Minute Walk Test (a standardised measure of distance walked over six minutes)
Timepoint [4] 264596 0
6 months
Secondary outcome [5] 276187 0
Cost effectiveness: Assessed for people with stroke via health service use (calculated from data collected by Medicare Australia, the Department of Veterans Affairs, the New South Wales Department of Health Inpatient Statistics Collections and the Pharmaceutical Benefits Scheme; including data related to GP and specialist consultations) and health benefits (SF-6D data calculated from the SF-36). The cost to deliver the intervention will be assessed by total program costs (cost of the workshop training materials, trainer's time and the opportunity cost of the trainee's time when attending the workshops) and outdoor journey costs (number of outdoor journey sessions delivered to each patient, as counted from file audits).
Timepoint [5] 276187 0
6 months

Eligibility
Key inclusion criteria
Rehabilitation Teams:
- A service providing rehabilitation to people with stroke who live in the community
- Employing at least 1 x physiotherapist
- Employing at least 1 x occupational therapist
- Receiving at least 20 x referrals of people with stroke in the previous 12 months


People with stroke:
- Stroke sustained no more than 12 months previous to starting therapy
- Able to walk 10 metres outdoors with/without a walking aid or supervision
- Over 18 years of age
- Living either at home, in a nursing home or hostel
- State that they would like to get out of the house more often than they currently do
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Rehabilitation teams:
- Teams solely providing transitional aged care

People with stroke:
- Severe cognitive deficits
- A level of English comprehension which precludes the ability to provide informed consent and/or to complete baseline measures.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Rehabilitation team recruitment:
Rehabilitation teams will be recruited across New South Wales (NSW). Teams will be contacted, and a meeting conducted, to explain the procedures. The NHMRC Clinical Trials Centre, or a "third party" independent of the trial, will conduct off-site concealed allocation of teams to one of two groups (experimental, control).

Each rehabilitation team will recruit as many patients as possible over 12 months. Given that this is a cluster randomised trial, people with stroke will be experimental or control by virtue of the allocation to condition of the rehabilitation team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Rehabilitation teams will be randomised using a central computerised randomisation service, administered independently by the NHMRC Clinical Trials Centre or a "third party" independent of the trial. A minimisation method will be used to ensure balance on the following factors: primary mode of service delivery (hospital-based or home-based), type of health sector (public or private), caseload size (high or low), average number of outings conducted at baseline.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
15/08/2011
Date of last participant enrolment
Anticipated
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257092 0
Government body
Name [1] 257092 0
NHMRC
Country [1] 257092 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 256395 0
Government body
Name [1] 256395 0
NHMRC
Address [1] 256395 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 256395 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259124 0
Sydney South West Area Health Service Human Research Ethics Committee - Concord Repatriation General Hospital Zone
Ethics committee address [1] 259124 0
Ethics committee country [1] 259124 0
Australia
Date submitted for ethics approval [1] 259124 0
17/12/2009
Approval date [1] 259124 0
20/01/2010
Ethics approval number [1] 259124 0
CH62/6/2009-194

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

Contacts
Principal investigator
Name 31248 0
Dr Annie McCluskey
Address 31248 0
Cumberland Campus C42
PO Box 170
University of Sydney
Sydney NSW 1825
Country 31248 0
Australia
Phone 31248 0
+61 2 9351 9834
Fax 31248 0
Email 31248 0
[email protected]
Contact person for public queries
Name 14495 0
Dr Annie McCluskey
Address 14495 0
PO Box 170
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141
Country 14495 0
Australia
Phone 14495 0
+61 2 9351 9834
Fax 14495 0
+61 2 9351 9177
Email 14495 0
[email protected]
Contact person for scientific queries
Name 5423 0
Dr Annie McCluskey
Address 5423 0
PO Box 170
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141
Country 5423 0
Australia
Phone 5423 0
+61 2 9351 9834
Fax 5423 0
+61 2 9351 9177
Email 5423 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
SourceTitleYear of PublicationDOI
EmbaseCompliance with Australian stroke guideline recommendations for outdoor mobility and transport training by post-inpatient rehabilitation services: An observational cohort study.2015https://dx.doi.org/10.1186/s12913-015-0952-7
N.B. These documents automatically identified may not have been verified by the study sponsor.