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Trial registered on ANZCTR


Registration number
ACTRN12609000741280
Ethics application status
Approved
Date submitted
25/08/2009
Date registered
26/08/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of brief interventions for enhancing early emotional adjustment following stroke: A pilot randomised controlled trial
Scientific title
Do stroke patients receiving either a self-management or cognitive-behavioural intervention demonstrate enhanced early emotional adjustment as compared with those receiving usual care?
Secondary ID [1] 280754 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Comparing the effectiveness of a brief self-management intervention, a brief cognitive-behavioural intervention with usual care on early emotional adjustment in stroke patients. 243491 0
Condition category
Condition code
Stroke 239792 239792 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 8-session self-management intervention will be conducted by an occupational therapist and will include the provision and reinforcement of individualised written information, and activities that are aimed at assisting individuals to learn problem-solving skills, perform functional tasks, and adjust to life post-stroke.

The 8-session coping skills intervention will be conducted by a clinical psychology trainee and will include cognitive and behavioural exercises to prepare individuals for discharge and to adjust post-discharge (for example, psychoeducation, self-monitoring, graduated activity participation, and cognitive restructuring).

In both groups, the 8 sessions will be of 1 hour duration and will be held once per week over 8 weeks, with the first session being held while the patient is still in hospital
Intervention code [1] 237111 0
Rehabilitation
Comparator / control treatment
Standard care: the usual contact that patients would receive from the hospital’s treating team members. This would include medical assessment and treatment, nursing care, assessment and/or treatment from allied health staff, discharge planning and any information or education associated with this treatment. The control group will receive no information or intervention from the research team
Control group
Active

Outcomes
Primary outcome [1] 240562 0
Presence or absence, and severity of anxiety and depressive symptoms as determined by structured interview based on the Diagnostic and Statistical Manual of Mental Disorders ? Fourth Edition, and the Hospital Anxiety and Depression Scale
Timepoint [1] 240562 0
Baseline (prior to hospital discharge), post intervention (approx 2 months post-discharge) and at 3 months post-intervention
Secondary outcome [1] 257157 0
Functional Performance as measured by the Modified Barthel Index and the Nottingham Extended Activities of Daily Living Scale
Timepoint [1] 257157 0
Baseline (prior to hospital discharge), post intervention (approx 2 months post-discharge) and at 3 months post-intervention
Secondary outcome [2] 257158 0
Cognitive appraisal ability as measured by the Stress Appraisal Coping Measure (SAM)
Timepoint [2] 257158 0
Baseline (prior to hospital discharge), post intervention (approx 2 months post-discharge) and at 3 months post-intervention
Secondary outcome [3] 257159 0
Self-efficacy as measured by a Self-Efficacy Questionnaire
Timepoint [3] 257159 0
Baseline (prior to hospital discharge), post intervention (approx 2 months post-discharge) and at 3 months post-intervention
Secondary outcome [4] 257160 0
Stroke knowledge as measured by the Knowledge of Stroke Questionnaire
Timepoint [4] 257160 0
Baseline (prior to hospital discharge), post intervention (approx 2 months post-discharge) and at 3 months post-intervention
Secondary outcome [5] 257161 0
Quality of Life as measured by the Stroke and Aphasia Quality of Life Scale (SAQOL)
Timepoint [5] 257161 0
Baseline (prior to hospital discharge), post intervention (approx 2 months post-discharge) and at 3 months post-intervention
Secondary outcome [6] 257162 0
Treatment expectations as measured by the Treatment Expectations Scale
Timepoint [6] 257162 0
End of 1st, 4th and 8th sessions (intervention participants only)
Secondary outcome [7] 257163 0
Self-awareness of deficits as measured by the Self-Perceptions in Rehabilitation Questionnaire (SPIRQ)
Timepoint [7] 257163 0
End of 1st, 4th and 8th sessions (intervention participants only)

Eligibility
Key inclusion criteria
Participants will:
- have a diagnosis of stroke
- be medically stable
- have adequate English and expressive and receptive communication skills, and
- have adequate cognitive capacity to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have:
- presence of a neurodegenerative condition (e.g. dementia), or
- home discharge destination further than 50km of the hospital

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)
The person who determines if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated. Concealed allocation will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Several days before discharge, an eligible participant will be advised of the study by a member of the Hospital’s treating team and be invited to received further information and/or participate. If agreeable, the principal researcher will provide more information and answer any questions. If they wish to participate, a research assistant will obtain their written consent and complete the initial interview. Participants will then be randomly allocated using a predetermined computer generated randomisation in strict order of interview.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237535 0
University
Name [1] 237535 0
University of Queensland
Address [1] 237535 0
The University of Queensland Graduate School The University of Queensland Cumbrae-Stewart Building Research Road Brisbane QLD 4072
Country [1] 237535 0
Australia
Funding source category [2] 237536 0
University
Name [2] 237536 0
Griffith University
Address [2] 237536 0
Griffith University, Messines Ridge Road, Mt Gravatt, QLD 4122
Country [2] 237536 0
Australia
Primary sponsor type
Individual
Name
Dr Tammy Hoffmann
Address
Division of Occupational Therapy School of Health and Rehabilitation Sciences Services Road The University of Queensland St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 237014 0
Individual
Name [1] 237014 0
Dr Tamara Ownsworth
Address [1] 237014 0
School of Psychology, Psychology Building (M24), Messines Ridge Road, Griffith University, Mt Gravatt, QLD 4122
Country [1] 237014 0
Australia
Other collaborator category [1] 828 0
Individual
Name [1] 828 0
Prof David Shum
Address [1] 828 0
School of Psychology, Psychology Building (M24), Messines Ridge Road, Griffith University, Mt Gravatt, QLD 4122
Country [1] 828 0
Australia
Other collaborator category [2] 829 0
Individual
Name [2] 829 0
Dr Stephen Read
Address [2] 829 0
Royal Brisbane and Women's Hospital Cnr Butterfield Street and Herston Road Herston QLD 4029
Country [2] 829 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243668 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 243668 0
Cnr of Butterfield Street and Herston Road Herston QLD 4029
Ethics committee country [1] 243668 0
Australia
Date submitted for ethics approval [1] 243668 0
Approval date [1] 243668 0
10/06/2009
Ethics approval number [1] 243668 0
EC00172
Ethics committee name [2] 243669 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 243669 0
), Messines Ridge Road, Griffith University, Mt Gravatt, QLD 4122
Ethics committee country [2] 243669 0
Australia
Date submitted for ethics approval [2] 243669 0
Approval date [2] 243669 0
16/07/2009
Ethics approval number [2] 243669 0
EC00162
Ethics committee name [3] 243670 0
The University of Queensland's Medical Research Ethics Committee
Ethics committee address [3] 243670 0
Research and Research Training Division Cumbrae-Stewart Building (72) The University of Queensland QLD 4072
Ethics committee country [3] 243670 0
Australia
Date submitted for ethics approval [3] 243670 0
Approval date [3] 243670 0
02/07/2009
Ethics approval number [3] 243670 0
EC00179

Summary
Brief summary
This project is a pilot randomised control trial employing a prospective longitudinal design. It aims to evaluate two brief intervention approaches for improving early emotional adjustment to stroke during the discharge and transition to home period by comparing them to a control group. The two interventions are a self-management approach and a cognitive-behavioural coping skills approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30034 0
Address 30034 0
Country 30034 0
Phone 30034 0
Fax 30034 0
Email 30034 0
Contact person for public queries
Name 13281 0
Dr Tammy Hoffmann
Address 13281 0
Division of Occupational Therapy
School of Health and Rehabilitation Sciences
Services Road
The University of Queensland
St Lucia, QLD 4072
Country 13281 0
Australia
Phone 13281 0
+61 7 5595 5522
Fax 13281 0
Email 13281 0
t.hoffmann@uq.edu.au
Contact person for scientific queries
Name 4209 0
Dr Tammy Hoffmann
Address 4209 0
Division of Occupational Therapy
School of Health and Rehabilitation Sciences
Services Road
The University of Queensland
St Lucia, QLD 4072
Country 4209 0
Australia
Phone 4209 0
+61 7 5595 5522
Fax 4209 0
Email 4209 0
t.hoffmann@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary