Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000469314
Ethics application status
Approved
Date submitted
26/08/2008
Date registered
22/09/2008
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a post-discharge education and support package for stroke clients and their carers: Randomised control trial (Does providing information after stroke help?)
Scientific title
Do stroke clients and carers provided with a post-discharge education and support package demonstrate better stroke knowledge as compared with those receiving usual care?
Secondary ID [1] 288168 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evaluating the effectiveness of an education and support package for clients with stroke and their carers. 3611 0
Condition category
Condition code
Stroke 3769 3769 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The education and support package consists of a written education booklet that provides tailored information, supplemented by verbal reinforcement and repetition of the information contained therein stroke. This verbal reinforcement will occur both face-to-face (prior to hospital discharge) and over the telephone (after hospital discharge) for up to 3 months post-discharge.

The written education booklet contains topics including the definition, causes, warning signs, risk factors, effects, diagnosis and treatment of stroke, as well as rehabilitation, recovery, returning to activities, going home, practical management strategies and services and support available after stroke.

Face-to-face contact will be made up to three times with intervention participants, each contact estimated to last between 5 and 20 minutes.

Telephone support will be initiated up to three times over the first 3 months post discharge, with each call estimated to last between 2 and 10 minutes. Additionally, over this time period, intervention participants will have the option to call to ask questions, again same time period.
Intervention code [1] 3324 0
Other interventions
Comparator / control treatment
Standard care: the usual contact that clients and their carers/family members 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 principal researcher.
Control group
Active

Outcomes
Primary outcome [1] 4708 0
Stroke-related knowledge as determined by a stroke knowledge questionnaire.
Timepoint [1] 4708 0
Baseline (just prior to discharge) and 3 months post-discharge
Secondary outcome [1] 7886 0
Stroke-risk factor awareness (as assessed by an opened ended question and a checklist of stroke-related risk factors requiring a yes/no/unsure response).
Timepoint [1] 7886 0
Baseline (just prior to discharge) and 3 months post-discharge.
Secondary outcome [2] 7947 0
Self-efficacy (using measures designed for this study).
Timepoint [2] 7947 0
Baseline (just prior to discharge) and 3 months post-discharge.
Secondary outcome [3] 7948 0
Stroke risk-related behaviour change (using a checklist requiring a yes/no/unsure response) and readiness to change these behaviours (using a single statement staging algorithm for each behaviour).
Timepoint [3] 7948 0
Baseline (just prior to discharge) and 3 months post-discharge.
Secondary outcome [4] 7949 0
Anxiety and depression (using the Hospital Anxiety and Depression Scale).
Timepoint [4] 7949 0
Baseline (just prior to discharge) and 3 months post-discharge.
Secondary outcome [5] 7950 0
Client quality of life (using the Stroke and Aphasia Quality of life Scale-39) and carer burden (using the Caregiver Strain Index).
Timepoint [5] 7950 0
Baseline (just prior to discharge) and 3 months post-discharge.
Secondary outcome [6] 7951 0
Satisfaction (questions regarding satisfaction and usefulness of information received using 10-point Likert scale; open ended questions regarding information needs and any positive or negative experiences).
Timepoint [6] 7951 0
Baseline (just prior to discharge) and 3 months post-discharge

Eligibility
Key inclusion criteria
Participants will:
- be clients - or carers of clients - with a current admission for stroke (first of subsequent)
- be medically stable with good prognosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
- have been living in a residential care facility prior to admission, or have residential care as a planned discharge destination, and/or
- have inadequate English, cognition, communication, vision and/or hearing to provide informed consent and complete the questionnaire/assessments.
If the client is excluded on the basis of the last criteria alone, but their carer meets all criteria, then the carer is still invited to participate.

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)
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, the principal researcher will obtain their written consent and complete the initial interview.
Randomisation will occur using sealed, opaque envelopes, marked for consecutive participants. After the initial interview is completed, the principal researcher will open the envelope to determine the participant’s random allocation. Participants will be randomised in this way in strict order of interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequentially numbered opaque envelopes will be prepared by a person unrelated to the study, using a random numbers table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
4/10/2008
Date of last participant enrolment
Anticipated
Actual
14/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3788 0
University
Name [1] 3788 0
The University of Queensland (Australia Post-graduate Award (APA) Scholarship)
Country [1] 3788 0
Australia
Primary sponsor type
Individual
Name
Sally Eames
Address
PhD Candidate
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] 3398 0
None
Name [1] 3398 0
Address [1] 3398 0
Country [1] 3398 0
Other collaborator category [1] 386 0
Individual
Name [1] 386 0
Dr Tammy Hoffmann
Address [1] 386 0
Lecturer
Division of Occupational Therapy
School of Health and Rehabilitation Sciences
Services Road
The University of Queensland
St Lucia, QLD 4072
Country [1] 386 0
Australia
Other collaborator category [2] 387 0
Individual
Name [2] 387 0
Prof Linda Worrall
Address [2] 387 0
Professor
Division of Speech Pathology
Co-Director, Communication Disability Centre
School of Health and Rehabilitation Sciences
Services Road
The University of Queensland
St Lucia, QLD 4072
Country [2] 387 0
Australia
Other collaborator category [3] 388 0
Individual
Name [3] 388 0
Dr Stephen Read
Address [3] 388 0
Neurologist
Royal Brisbane and Women's Hospital
Cnr Butterfield Street and Herston Road
Herston QLD 4029
Country [3] 388 0
Australia
Other collaborator category [4] 624 0
Individual
Name [4] 624 0
Dr Andrew Wong
Address [4] 624 0
Neurologist
The Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [4] 624 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5850 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 5850 0
Cnr of Butterfield Street and Herston Road
Herston QLD 4029
Ethics committee country [1] 5850 0
Australia
Date submitted for ethics approval [1] 5850 0
Approval date [1] 5850 0
11/08/2008
Ethics approval number [1] 5850 0
EC00172 (Reference number 2008/088)
Ethics committee name [2] 6756 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [2] 6756 0
Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [2] 6756 0
Australia
Date submitted for ethics approval [2] 6756 0
18/12/2008
Approval date [2] 6756 0
11/02/2009
Ethics approval number [2] 6756 0
EC00167 (Reference Number 2009/007)
Ethics committee name [3] 6757 0
The University of Queensland's Medical Research Ethics Committee
Ethics committee address [3] 6757 0
Research and Research Training Division
Cumbrae-Stewart Building (72)
The University of Queensland
QLD 4072
Ethics committee country [3] 6757 0
Australia
Date submitted for ethics approval [3] 6757 0
20/03/2009
Approval date [3] 6757 0
28/03/2009
Ethics approval number [3] 6757 0
EC00179 (Project Number: 2008001561)

Summary
Brief summary
The provision of information is recognised as a key component of post-stroke management for clients, their carers and their families and can improve client and carer knowledge, reduce client depression and increase some aspects of client satisfaction. Clients with stroke and their families need, and want, information about stroke, across a broad content range and there is evidence that their education and support needs are not met by current practice.

Current recommendations for effective information provision include providing a combining verbal and written information, using an interactive teaching style and repetition or reinforcement of information.

Preliminary research conducted by this team sought stroke clients’ and carers’ content, format, teaching style and timing preferences regarding stroke educational support. Although this data is as yet unpublished, it confirms support for the aforementioned recommendations (combination of written and verbal information, an interactive style and reinforcement). It was further established that a combination of face-to-face and telephone contact is acceptable to clients with stroke and their carers. As a result, an education and support package was developed, consisting of a previously trialled Australian tailored written education booklet, supplemented by verbal reinforcement and repetition of the information contained therein.

This study will evaluate the impact of this education and support package through a single-blind randomised control trial, by comparing the health and psychosocial outcomes of participants in the intervention group with those of participants in the control group, who will receive usual care. Outcome measures will be administered prior to hospital discharge and again at three months post discharge.
Trial website
Trial related presentations / publications
Eames, Hoffmann, Worrall, Read and Wong (2013) Randomised controlled trial of an education and support package for stroke patients and their carers BMJ Open 3:e002538

Eames, Hoffmann and Phillips (2014) Evaluating stroke patients’ awareness of risk factors and readiness to change stroke risk-related behavior in a randomized controlled trial Topics in Stroke Rehabilitation 21: S52-62
Public notes

Contacts
Principal investigator
Name 28878 0
Dr Sally Eames
Address 28878 0
Occupational Therapy Department
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD, 4012
Country 28878 0
Australia
Phone 28878 0
+61 (0)7 3176 5008
Fax 28878 0
Email 28878 0
[email protected]
Contact person for public queries
Name 12035 0
Sally Eames
Address 12035 0
PhD Candidate
Division of Occupational Therapy
School of Health and Rehabilitation Sciences
Services Road
The University of Queensland
St Lucia, QLD 4072
Country 12035 0
Australia
Phone 12035 0
+ 61 7 3365 2870
Fax 12035 0
+ 61 7 3365 1622
Email 12035 0
[email protected]
Contact person for scientific queries
Name 2963 0
Sally Eames
Address 2963 0
PhD Candidate
Division of Occupational Therapy
School of Health and Rehabilitation Sciences
Services Road
The University of Queensland
St Lucia, QLD 4072
Country 2963 0
Australia
Phone 2963 0
+ 61 7 3365 2870
Fax 2963 0
Email 2963 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
EmbaseEvaluating stroke patients' awareness of risk factors and readiness to change stroke risk-related behaviors in a randomized controlled trial.2014https://dx.doi.org/10.1310/tsr21S1-S52
N.B. These documents automatically identified may not have been verified by the study sponsor.