Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000979651
Ethics application status
Approved
Date submitted
29/07/2014
Date registered
11/09/2014
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing the impact of aphasia in stroke patients and their caregivers a year post onset via a brief early intervention: a cluster randomised control trial of the Aphasia Action Success Knowledge (ASK) program.
Scientific title
Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: study protocol for a randomized controlled trial
Secondary ID [1] 284940 0
Nil
Universal Trial Number (UTN)
U1111-1159-0323
Trial acronym
The ASK study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292421 0
Stroke 292937 0
Aphasia 292938 0
Condition category
Condition code
Mental Health 293232 293232 0 0
Depression
Physical Medicine / Rehabilitation 293233 293233 0 0
Speech therapy
Stroke 293283 293283 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Aphasia ASK intervention consists of a face to face intervention and follow-up phone calls provided by a speech pathologist up until 12 months post stroke. The intervention is for 6 to 8 weeks for an hour each week. The topics in the intervention include a number of modules and cover a range of areas including: caregiver training (e.g. communication partner training), education (on aphasia, successful coping strategies and support services) stress management, positive adaptive strategies, sharing of personal stories and developing peer-based support. The participants will be able to prioritise the order of modules based on their personal interest and needs. The prioritisation occurs during the module “getting started”. Each module is colour coded rather than numbered to assist with this process. The first session establishes the goals for the program using collaborative goal setting techniques. The goals form the basis for prioritising the modules that are covered in future weeks. For example, if the participant’s goal is to stay positive, there is a module on positive thinking that includes information about and practice on exercises for strategies which were drawn from the counselling literature. At the end of each module, further resources are recommended including community based options/programmes/resources. Goals are revisited each session. The modules are designed as a guide and should be incorporated with clinical skill and knowledge to ensure the program is person-centred. Aphasia ASK is to be delivered as individual sessions with only one participant with aphasia and their family member(s) involved at any one time. Follow-up monthly phone calls or visits (which ever method is suitable for the participants) will be made until 12 months post stroke. The follow up calls with revisit the participant goals set during the program and provide additional information and resources where necessary. An Aphasia ASK program manual has been written for the provider therapist and a separate aphasia friendly workbook has been written for the recipients. Recipients will receive the written materials prior to each session.
Intervention code [1] 289772 0
Prevention
Intervention code [2] 289775 0
Rehabilitation
Intervention code [3] 290164 0
Behaviour
Comparator / control treatment
A secondary stroke prevention program forms the content of the attention control package. It will be provided in a similar dosage (1 hour session per week for 6-8 weeks and follow-up monthly phone calls until 12 months post stroke) and similar format (written support materials, delivered to both patients and their family) to the Aphasia ASK intervention The information that will inform the modules will include:
What is stroke? Recovery from stroke
Understanding risk factors for stroke Lifestyle interventions
Barriers to implementing lifestyle changes
Understanding your medication
Control group
Active

Outcomes
Primary outcome [1] 292588 0
Assessment for Living with Aphasia (ALA)
Timepoint [1] 292588 0
12 months post stroke
Primary outcome [2] 292589 0
Stroke and Aphasia Depression Questionnaire (SADQ-10)
Timepoint [2] 292589 0
12 months post stroke
Secondary outcome [1] 309277 0
Bakas Caregiver Outcomes Scale –Revised (BCOS)
Timepoint [1] 309277 0
12 months post stroke
Secondary outcome [2] 309278 0
General Health Questionnaire (GHQ)
Timepoint [2] 309278 0
12 months post stroke
Secondary outcome [3] 325112 0
The secondary outcome for people with aphasia will include a 10-item measure of self-reported stroke risk-related behaviors. Both ideal (for example, taking medication as prescribed) and nonideal behaviors (for example, smoking cigarettes) will be measured with higher scores out of 10 indicating performance of more ideal behaviors. See Eames S, Hoffmann TC, Phillips NF. Evaluating stroke patients’ awareness of risk factors and readiness to change stroke risk-related behaviors in a randomized controlled trial. Top Stroke Rehabil. 2014;21 S52–62
Timepoint [3] 325112 0
12 months post stroke

Eligibility
Key inclusion criteria
Inclusion criteria for aphasia patients include:
Onset of first stroke in the past 6 months and diagnosis of aphasia
18 years

Inclusion criteria for nominated family members if able to be involved include:
> 18 years
Sufficient hearing level and English language skills to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with aphasia and their family member(s) will be excluded if they have concomitant progressive neurological conditions (for example, dementia) or a concurrent medical condition impacting on their mental health (for example, cancer) as confirmed by self-report. There are no other inclusion or exclusion criteria for family member participants.

People with aphasia must present with their first incidence of post stroke aphasia and will be excluded for the following reasons:
1) aphasia as an etiology other than stroke,
2) a current psychiatric diagnosis (for example, depressive disorder or anxiety disorder confirmed by medical record),
3) current depressive symptoms upon screening with the Stroke Aphasic Depression Questionnaire Hospital Version-10 (score of 12 or more) or The Depression Intensity Scale Circles (score of 3 or more),
4) receiving treatment in a psychiatric setting, or
5) enrolled in other aphasia or depression treatment studies.

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)
Hospital clusters will be randomised to either one of the two treatment arms. Participants will undergo the assigned treatment arm with a qualified speech pathologist from when they are first recruited until 12 months post stroke. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations were calculated for both primary outcome measures (ALA and SADQ-21). Power calculations on the ALA have been calculated from an intensive aphasia treatment study and an Australian longitudinal aphasia study. Power calculations on the SADQ have been calculated from the Cost analysis of the Communication and Low Mood (CALM) study. The ALA required a larger sample size compared to the SADQ-21, and therefore, the larger sample size required by the ALA was determined necessary to adequately power the study. To achieve a power of 80 % with a 5 % level of significance in comparing the two arms of the study (Aphasia ASK versus attention control - SSPIP), we need 186 patients (93 per arm) with an effect size of 0.367, computed using ALA data. The extent to which power is diminished by clustering was considered in relation to the design effect (DE) =1 + (m -1)r10, where m = the average size of a cluster and r is the intra-class correlation coefficient. Typically, intraclass correlation coefficients are small (<0.02); thus a conservatively estimated intra-class correlation of 0.02 was used. A cluster size of 20 was chosen based on the feasibility of running the intervention, as well as the availability of patients with aphasia within clusters. Thus DE = 1+ (20-1)*0.02 = 1.38, and the total sample size required was calculated as 186 * 1.38 ˜ 258. To account for an attrition rate of 25 % to the 12-month follow-up period, 344 patients would be needed (172 per arm).

Baseline characteristics of participating patients of the two arms will be presented and compared for any meaningful differences at baseline. Outcomes of interest will be analyzed on an intention-to-treat basis. Multilevel modelling using mixed models, which takes into account patients being nested within clusters, will be able to examine whether changes in the outcomes, which are on interval-scale, vary over time as well as across the two (Aphasia ASK and attention control- SSPIP) programs, after adjusting for the effects of any potential confounders (if any). In addition, attrition patterns across the two arms will be examined to determine randomness of missing data, and if required, multiple imputations will be implemented. All statistical analyses will be performed using Stata statistical software. An alpha level of 0.05 will be accepted as significant. The results of the statistical models will be presented in the form of regression coefficients, their 95 % confidence intervals, and effect sizes. The residuals of the fitted models will be examined to ensure that all required assumptions are met. The statistician completing the data analyses will be blinded to group allocation until analysis is completed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2015
Actual
24/11/2015
Date of last participant enrolment
Anticipated
30/05/2019
Actual
Date of last data collection
Anticipated
30/11/2019
Actual
Sample size
Target
344
Accrual to date
148
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289569 0
Government body
Name [1] 289569 0
National Health and Medical Research Council
Country [1] 289569 0
Australia
Primary sponsor type
University
Name
The University Of Queensland
Address
Brisbane, St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 288251 0
None
Name [1] 288251 0
Address [1] 288251 0
Country [1] 288251 0
Other collaborator category [1] 278040 0
University
Name [1] 278040 0
University of Sydney
Address [1] 278040 0
The University of Sydney
NSW 2006
Australia
Country [1] 278040 0
Australia
Other collaborator category [2] 278041 0
University
Name [2] 278041 0
Bond University
Address [2] 278041 0
14 University Dr, Robina QLD 4226
Country [2] 278041 0
Australia
Other collaborator category [3] 278042 0
University
Name [3] 278042 0
University of Western Sydney
Address [3] 278042 0
Hawkesbury Campus,, College Dr, Richmond NSW 2753
Country [3] 278042 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291306 0
Darling Downs Hospital Health Service
Ethics committee address [1] 291306 0
Ethics committee country [1] 291306 0
Australia
Date submitted for ethics approval [1] 291306 0
Approval date [1] 291306 0
26/06/2014
Ethics approval number [1] 291306 0
EC00182

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49790 0
Prof Linda Worrall
Address 49790 0
Speech Pathology
The University of Queensland
St Lucia, QLD 4072
Country 49790 0
Australia
Phone 49790 0
+617 3365 2891
Fax 49790 0
Email 49790 0
[email protected]
Contact person for public queries
Name 49791 0
Brooke Ryan
Address 49791 0
Speech Pathology
The University of Queensland
St Lucia, QLD 4072
Country 49791 0
Australia
Phone 49791 0
+61733651380
Fax 49791 0
Email 49791 0
[email protected]
Contact person for scientific queries
Name 49792 0
Brooke Ryan
Address 49792 0
Speech Pathology
The University of Queensland
St Lucia, QLD 4072
Country 49792 0
Australia
Phone 49792 0
+61733651380
Fax 49792 0
Email 49792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not received ethical clearance for data sharing


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
EmbaseReducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: Study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1257-9
EmbaseThe Aphasia Action, Success, and Knowledge Programme: Results from an Australian Phase i Trial of a Speech-Pathology-Led Intervention for People with Aphasia Early Post Stroke.2017https://dx.doi.org/10.1017/BrImp.2017.5
N.B. These documents automatically identified may not have been verified by the study sponsor.