Trial registered on ANZCTR


Trial ID
ACTRN12608000042347
Ethics application status
Approved
Date submitted
9/01/2008
Date registered
29/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
From rehabilitation to recovery: A model to optimise consumer and carer involvement in the first year post stroke
Scientific title
The first year after stroke: the efficacy of an intergrated approach aimed at facilitating stroke survivors and their carers to achieve personal goals in order to reduce post stroke depression and improve quality of life, compared to usual patient care approach.
Secondary ID [1] 259635 0
SVHM1
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Stroke 2688 0
Depression 2689 0
Quality of Life 2690 0
Carer burden 2691 0
Condition category
Condition code
Stroke 2806 2806 0 0
Haemorrhagic
Stroke 2807 2807 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Collaborative goal setting with the patient and carer prior to discharge from rehabilitation.
Monitoring of goal achievement and barriers to goal achievement.
Collaborative problem solving to overcome barriers.
Facilitated referral to health and community agencies, tailored to needs.
Promotion of healthy and active lifestyles.
Promotion of self efficacy and self reliance.
Providing targeted carer support through information provision, emotional support and practical support tailored to needs over a 12 month period.
Minimum of four interventions, maximum twelve.
Intervention code [1] 2426 0
Rehabilitation
Comparator / control treatment
Usual care plus phone contact with an allied health practitioner on three occasions for general support and encouragement.
Control group
Active

Outcomes
Primary outcome [1] 3694 0
Mean Assessment of Quality of Life score for carers
Timepoint [1] 3694 0
6 and 12 months after stroke
Primary outcome [2] 3695 0
Mean Geriatric Depression Scale score for stroke survivors
Timepoint [2] 3695 0
Baseline (discharge from rehabilitation admission), 6 and 12 months after stroke
Secondary outcome [1] 6235 0
Zarit Caregiver Burden Scale - carers
Timepoint [1] 6235 0
6 and 12 months after stroke
Secondary outcome [2] 6236 0
Functional Independence Measure (motor subset)
Timepoint [2] 6236 0
Baseline, 6 and 12 months post stroke
Secondary outcome [3] 6237 0
Minimental State Examination - stroke survivors
Timepoint [3] 6237 0
Baseline, 6 and 12 months post stroke
Secondary outcome [4] 6238 0
London Handicap Scale - stroke survivors
Timepoint [4] 6238 0
Baseline, 6 and 12 months post stroke
Secondary outcome [5] 6239 0
Activity Card Sort - stroke survivors
Timepoint [5] 6239 0
Baseline, 6 and 12 months post stroke
Secondary outcome [6] 6240 0
Strategies Used by People to Promote Health Scale - stroke survivors
Timepoint [6] 6240 0
Baseline, 6 and 12 months post stroke

Eligibility
Key inclusion criteria
Patient admitted for rehabilitation with a primary diagnosis of acute stroke.
Carers
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Discharge from rehabiliation to nursing home.
Primary cause of disabilities is a diagnosis other than stroke.
Living more than one hour travel time from St.Vincent's Health Melbourne.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/03/2008
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
120
Actual sample size
Recruitment status
Active, not recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2944 0
Government body
Name [1] 2944 0
Auatralian Research Council (ARC)
Address [1] 2944 0
GPO Box 2702
Canberra
ACT 2601
Country [1] 2944 0
Australia
Primary sponsor type
Hospital
Name
St.Vincent's Health Melbourne
Address
PO Box 2900
Fitzroy
Victoria 3065
Country
Australia
Secondary sponsor category [1] 2657 0
University
Name [1] 2657 0
The University of Melbourne
Address [1] 2657 0
Faculty of Medicine Dentistry and Health Sciences
Grattan Street
Parkville
Victoria 3052
Country [1] 2657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4886 0
St.Vincent's Health Melbourne
Ethics committee address [1] 4886 0
PO Box 2900
Fitzroy
Victoria 3065
Ethics committee country [1] 4886 0
Australia
Date submitted for ethics approval [1] 4886 0
12/12/2007
Approval date [1] 4886 0
Ethics approval number [1] 4886 0
162/07

Summary
Brief summary
Despite an acknowledgement of the significance of carer support and consumer involvement in recovery, to date there is a lack of empirical evidence regarding their impact on the outcome of rehabilitation programs for stroke patients. The aim of this study is to develop a consumer and carer centred model to assist with recovery and community reintegration in the first year after the onset of stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28282 0
Address 28282 0
Country 28282 0
Phone 28282 0
Fax 28282 0
Email 28282 0
Contact person for public queries
Name 11439 0
Christine Graven
Address 11439 0
Physiotherapy Department
St.Vincent's Health Melbourne
PO Box 2900
Fitzroy 3065
Victoria
Country 11439 0
Australia
Phone 11439 0
(03) 9288 3827
Fax 11439 0
Email 11439 0
Christine.GRAVEN@svhm.org.au
Contact person for scientific queries
Name 2367 0
Christine Graven
Address 2367 0
Physiotherapy Department
St.Vincent's Health Melbourne
PO Box 2900
Fitzroy 3065
Victoria
Country 2367 0
Australia
Phone 2367 0
(03) 9288 3827
Fax 2367 0
Email 2367 0
Christine.GRAVEN@svhm.org.au