ANZCTR - Registration

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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]

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.

Condition category

Condition code

Physical Medicine / Rehabilitation

Occupational therapy

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

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]

Behaviour

Intervention code [2]

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]

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]

12 months.

Primary outcome [2]

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]

12 months

Secondary outcome [1]

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]

6 months

Secondary outcome [2]

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]

6 months

Secondary outcome [3]

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]

6 months

Secondary outcome [4]

People with stroke: Walking capacity, measured by the 6-Minute Walk Test (a standardised measure of distance walked over six minutes)

Timepoint [4]

6 months

Secondary outcome [5]

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]

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?

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]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

The University of Sydney
NSW 2006
Australia

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney South West Area Health Service Human Research Ethics Committee - Concord Repatriation General Hospital Zone

Ethics committee address [1]

SSWAHS
Human Research Ethics Committee - CRGH
Concord Repatriation General Hospital
Concord NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/12/2009

Approval date [1]

20/01/2010

Ethics approval number [1]

CH62/6/2009-194

Summary

Brief summary

The Out-and-about trial aims to change the practice of rehabilitation teams working with people with stroke in New South Wales, as well as increasing community participation in people with stroke. The trial will compare different types of education provided to 20 community rehabilitation teams and 300 people with stroke who they see over 12 months.  It is hypothesised that teams that receive one type of education will perform better than teams that receive the other type of education.

Trial website

Trial related presentations / publications

PUBLICATIONS:
McCluskey, A., Ada, L., Middleton, S., Kelly, P. J., Goodall, S., Grimshaw, J. M., Logan, P., Longworth, M. & Karageorge, A. (2013). Improving quality of life by increasing outings after stroke: study protocol for the Out-and-About trial. International Journal of Stroke, 8: 54–58. doi: 10.1111/j.1747-4949.2012.00966

PUBLICATIONS IN PROGRESS:
McCluskey, A., Ada, L., Middleton, S., Kelly, P., Goodall, S., Grimshaw, J., Logan, P., Longworth, M., Karageorge, A. Assisting stroke survivors to get out and about: Are Australian post-inpatient rehabilitation services complying with national stroke guideline recommendations? An observational cohort study.

McCluskey, A., Ada, L., Middleton, S., Kelly, P. J., Goodall, S., Grimshaw, J. M., Logan, P., Longworth, M. & Karageorge, A.  The Out-and-About program to change the behaviour of community teams and increase outings by stroke survivors: A cluster-randomised trial.

Karageorge, A., Vargas, J., McCluskey, A., & Ada, L. Predictors of community outings after stroke: an observational study

PRESENTATIONS:
McCluskey, A., Ada, L., Kelly, P. K., Middleton, S., Goodall, S., Longworth, M., Grimshaw, J., Logan, P., & Karageorge, A. Frequency of outings by recently discharged stroke survivors. Oral presentation at Smart Strokes 2013 Conference, 22 – 23 August 2013, Brisbane Australia.

McCluskey, A., Ada, L., Kelly, P. K., Middleton, S., Goodall, S., Longworth, M., Grimshaw, J., Logan, P., & Karageorge, A. Large variations exist in therapy provided to community stroke survivosr. Oral presentation at Australian 25th National Occupational Therapy Conference, 24 - 26 July 2013, Adelaide Australia.

McCluskey, A., et al (2012, May). Low compliance with national stroke guidelines: few physiotherapy or occupational therapy sessions occur outdoors in public streets. Poster session presented at the 7th World Congress for NeuroRehabilitation, Melbourne, VIC, Australia.

McCluskey, A., et al (2012, October). Low compliance with national stroke guidelines: few physiotherapy or occupational therapy sessions occur outdoors in public streets. Poster session presented at the 8th World Stroke Congress, Brasilia, Brazil.

McCluskey, A., et al (2012, August) A profile of non-inpatient rehabilitation services in NSW:  Variations in waiting times, frequency and nature of therapy – Paper presentation at the Stroke Society of Australasia/Smart Strokes National Conference, Sydney, NSW, Australia.

Public notes

Contacts

Principal investigator

Name

Dr Annie McCluskey

Address

Cumberland Campus C42
PO Box 170
University of Sydney
Sydney NSW 1825

Country

Australia

Phone

+61 2 9351 9834

Fax

annie.mccluskey@sydney.edu.au

Contact person for public queries

Name

Dr Annie McCluskey

Address

PO Box 170
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141

Country

Australia

Phone

+61 2 9351 9834

Fax

+61 2 9351 9177

annie.mccluskey@sydney.edu.au

Contact person for scientific queries

Name

Dr Annie McCluskey

Address

PO Box 170
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141

Country

Australia

Phone

+61 2 9351 9834

Fax

+61 2 9351 9177

annie.mccluskey@sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Compliance with Australian stroke guideline recommendations for outdoor mobility and transport training by post-inpatient rehabilitation services: An observational cohort study.	2015	https://dx.doi.org/10.1186/s12913-015-0952-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

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