Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000169347
Ethics application status
Approved
Date submitted
20/03/2008
Date registered
7/04/2008
Date last updated
7/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
"Getting your life back on track after stroke" (A Phase II multi centred, Single Blind, Randomised, Controlled Trial of the Stroke Self Management Program versus Standard Care or the Chronic Condition Self Management Program in Stroke Survivors)
Scientific title
"Getting your life back on track after stroke" (A Phase II multi centred, Single Blind, Randomised, Controlled Trial of the Stroke Self Management Program versus Standard Care or the Chronic Condition Self Management Program in Stroke Survivors)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Determining the most effective model of self management for stroke survivors 2952 0
Condition category
Condition code
Stroke 3092 3092 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1 - Chronic Condition Self Management Program. Participants will receive usual care and undertake the
Chronic Condition Self Management Program. This generic education
program runs with a range of disease groups including stroke. Participants will attend the program 1 x 2.5 hr session per week for six weeks. The program involves presentations, group activities and hand outs.
Intervention 2 - Stroke Self Management Program. Participants will receive usual care and undertake the Stroke Self Management Program. This stroke specific, education program is designed to help "get life back on track" after stroke. Participants will attend the program 1 x 2.5 hr session per week for eight weeks. The program involves presentations, group activities and hand outs.
Intervention code [1] 2684 0
Other interventions
Comparator / control treatment
"Standard Care" participants will receive their usual care when they are discharged from hospital. They may be managed by their general practitioner, referred to community services, given information about life after stroke, or join a stroke support group.
Control group
Active

Outcomes
Primary outcome [1] 3980 0
Improvements in positive and active engagement in life as
measured by the Health Education Impact Questionnaire (heiQ).
Timepoint [1] 3980 0
6 months
Secondary outcome [1] 6697 0
Improvement in mood as measured by the Irritability, Depression and Anxiety Scale
Timepoint [1] 6697 0
6 months
Secondary outcome [2] 6698 0
Cost benefits as measured by the particpant held diary
Timepoint [2] 6698 0
6 months

Eligibility
Key inclusion criteria
1/ Participants 18 years and over with a clinical diagnosis of stroke. (Participants who have had a previous stroke will be included in the study)

2/ Participants must be living in the community or have the capacity to return to living in the community.

3/ Participants must be at least 3 months post stroke event.

4/ Participants may have cognitive impairment

5/ Participants may have language difficulties.

6/ Participants may be living independently or assisted by a carer (or carers).

(The carer may attend in the self management program.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1/ Previous participation in any type of Self Management Program.
2/ People who live or will live in an aged care facility prior to commencement of the study
3/ Patients who are not able or willing to attend a self management program for 2.5 hours per week for up to 8 weeks.
4/ Patient for whom English is a second language

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)
Participants may be recruited in the following manner.
1/ Letter from the Head of the Stroke Unit to all eligible participants at 5 hospital sites across Adelaide,
2/ Advertising in local Adelaide newspapers, 3/ Flyer in Stroke SA newsletter
4/ Promotion through Divisions of General Practice
5/ Word of mouth.
The Research Assistant will undertake a telephone screen with all participants to ensure eligibility. This will be followed by a home visit to obtain consent and complete initial assessment.
Allocation is concealed as the allocation involves contacting the holder of the allocation schedule (the Stroke Educator) at a central administration site. The Stroke Educator then utilises a centralised randomisation process using a remote, telephone based, computer generated procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A remote, telephone based, computer-generated randomisation procedure will be used. This service is provided by an independent organisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3207 0
Charities/Societies/Foundations
Name [1] 3207 0
J.R and J.O. Wicking Trust
Country [1] 3207 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] 2875 0
None
Name [1] 2875 0
Address [1] 2875 0
Country [1] 2875 0
Other collaborator category [1] 245 0
University
Name [1] 245 0
Associate Professor Malcolm Battersby Director
Flinders Human Behaviour and Health Research Unit
Address [1] 245 0
Margaret Tobin Centre
GPO Box 2100
Bedford Park SA
Country [1] 245 0
Australia
Other collaborator category [2] 246 0
Hospital
Name [2] 246 0
Professor Richard Lindley
Chair of Geriatric Medicine
Westmead Hospital
Address [2] 246 0
Department of Geriatric Medicine
Westmead Hospital
Darcy Rd
Westmead NSW
Country [2] 246 0
Australia
Other collaborator category [3] 247 0
Other Collaborative groups
Name [3] 247 0
Associate Professor Helen Dewey
Neurologist
National Stroke Research Institute
Address [3] 247 0
Level 1
Neurosciences Building
Repatriation Hospital
Austin Health
Heidelberg Heights VIC 3081
Country [3] 247 0
Australia
Other collaborator category [4] 248 0
Other Collaborative groups
Name [4] 248 0
Associate Professor Richard Osborne
National Health and Medical Research Council (NHMRC) Population Health Fellow
Centre for Rheumatic Diseases
Address [4] 248 0
Department of Medicine (RMH/WH)
The University of Melbourne
Parkville
Melbourne VIC 3050
Country [4] 248 0
Australia
Other collaborator category [5] 249 0
Other Collaborative groups
Name [5] 249 0
Ms D Cadilhac
Manager
Public Health
National Stroke Research Institute
Address [5] 249 0
Level 1
Neurosciences Building
Repatriation Hospital
Austin Health
Heidelberg Heights VIC 3081
Country [5] 249 0
Australia
Other collaborator category [6] 250 0
University
Name [6] 250 0
Dr Velandei Srikanth
Senior Lecturer
Monash University
Address [6] 250 0
Department of Medicine
Block E
Level 5
Monash Medical Centre
Clayton VIC 3168
Country [6] 250 0
Australia
Other collaborator category [7] 251 0
University
Name [7] 251 0
Dr Andrew Lee
Neurologist and Cerebrovascular Physician
Flinders University
Address [7] 251 0
Flinders University Department of Neurology
Flinders Medical Centre
Department of Neurology
Bedford Drive
Bedford Park SA
Country [7] 251 0
Australia
Other collaborator category [8] 252 0
Charities/Societies/Foundations
Name [8] 252 0
Dr E. Lalor
CEO National Stroke Foundation
Address [8] 252 0
Level 7
461 Bourke St
Melbourne VIC 3000
Country [8] 252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5187 0
Ethics of Human Research Committee (The Queen Elizabeth Hospital; and Lyell McEwin Hospital)
Ethics committee address [1] 5187 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South SA 5011
Ethics committee country [1] 5187 0
Australia
Date submitted for ethics approval [1] 5187 0
Approval date [1] 5187 0
10/11/2007
Ethics approval number [1] 5187 0
2007162
Ethics committee name [2] 5188 0
The Flinders Clinical Research Ethics Committee
Flinders Medical Centre
Ethics committee address [2] 5188 0
Level 2
Room 2A221
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [2] 5188 0
Australia
Date submitted for ethics approval [2] 5188 0
Approval date [2] 5188 0
12/11/2007
Ethics approval number [2] 5188 0
108/07
Ethics committee name [3] 5189 0
The Research Ethics Committee
The Royal Adelaide Hospital
Ethics committee address [3] 5189 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [3] 5189 0
Australia
Date submitted for ethics approval [3] 5189 0
Approval date [3] 5189 0
05/12/2007
Ethics approval number [3] 5189 0
071115

Summary
Brief summary
Each year 53,000 Australians have a stroke and 88% return home to the community. Stroke survivors struggle to recover quality of life at home.Self management programs are a new initiative designed to help people living with a chronic condition manage their day to day lives more effectively, improve quality of life and live a more healthy lifestyle. In 2004/06, the National Stroke Foundation developed and piloted a stroke self management program. The Phase 1 trial demonstrated positive outcomes for the participants. The aim of this Phase 2 trial is to test the proposed research protocol and outcome measures, whilst validating the effect size calculation in preparation for a Phase 3 larger RCT.
Participants will be recruited from six hospitals in Adelaide with a letter from the HEad of the Stroke Unit, through advertising in local Adelaide newspapers, through Stroke SA, general practice or word of mouth. Stroke survivors returning home or already living in the community,3/12 after their stroke will be invited to participate. Participants will be randomly allocated to one of three groups: The first group, "Standard Care" will receive their usual care when they are discharged from hospital. They may be managed by their GP, referred to community services, given information about life after stroke, or join a stroke support group. The second group will receive usual care and undertake the Chronic Condition Self Management Program. This generic, six week education
program runs with a range of disease groups including stroke. The third group will
receive usual care and undertake the Stroke Self Management Program. This eight week education program is designed to help "get life back on track" after stroke.
All participants will be assessed prior to admission to the program, at 6-8 weeks
and at 6 months. The assessor will be unaware of the group allocation. The primary outcome measure is improvements in positive and active engagement in life as
measured by the hei-Q. The hei-Q is designed to measures changes in self
management programs. Improvements in quality of life, mood and cost benefits
are secondary outcomes. This is the first time in the world that the impact of
cognition, language and physical disability on a person's ability to self manage will
be explored. An accurate record of adverse events shall be maintained. Participants will be informed of their right to withdraw at any time without prejudice
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28457 0
Address 28457 0
Country 28457 0
Phone 28457 0
Fax 28457 0
Email 28457 0
Contact person for public queries
Name 11614 0
Sally Hoffmann
Address 11614 0
National Stroke Foundation
Level 7
461 Bourke St
Melbourne VIC 3000
Country 11614 0
Australia
Phone 11614 0
+61 3 96701000
Fax 11614 0
+61 3 96709300
Email 11614 0
sally@strokefoundation.com.au
Contact person for scientific queries
Name 2542 0
Associate Professor Malcolm Battersby
Address 2542 0
Director
Flinders Human Behavior and Health Research Unit
Margaret Tobin Centre
GPO Box 2100
Bedford Park SA
Country 2542 0
Australia
Phone 2542 0
+61 8 84042323
Fax 2542 0
Email 2542 0
malcolm.battersby@fmc.sa.gov.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

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