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Trial registered on ANZCTR


Registration number
ACTRN12613001182785
Ethics application status
Approved
Date submitted
21/10/2013
Date registered
29/10/2013
Date last updated
29/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a new intensive model of aphasia rehabilitation achieve better outcomes than usual care with chronic aphasia resulting from stroke?
Scientific title
In patients with chronic aphasia resulting from Cerebrovascular accident (CVA), does a new intensive, comprehensive aphasia rehabilitation program, compared with usual speech pathology care, provide better language and quality of life outcomes.
Secondary ID [1] 283165 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 290198 0
Aphasia 290199 0
Condition category
Condition code
Stroke 290591 290591 0 0
Ischaemic
Stroke 290592 290592 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 290765 290765 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The University of Queensland's Aphasia LIFT program seeks to integrate all aspects of what people with aphasia and their families want with evidence-based components into a “package”. LIFT involves over 50 hours of intervention per participant and incorporates individual impairment-based therapy, individual functional therapy computer therapy and group sessions for information sharing and discussion of topics related to living with aphasia & topics requested by participants. It seeks to provide participants with tools to practice language themselves through use of commercial computerised aphasia programs in treatment, as well as instruction on how to develop their own personalised therapy materials. Mobile technology such as iPads & iPhones are used frequently both to achieve communication goals such as being able to text short messages to family and friend and to maintain practice schedules. In the maintenance phase (weeks 4-7) participants will use a tablet-based therapy program at home, monitored and updated regularly by the speech pathologist. Data will be gathered on time spent on the therapy tasks as well as progress. The speech pathologist will also 'check-in' with the participant via telephone to talk through any issues and check that the participant is adhering to the program. In addition, LIFT links them into community resources (peer-led aphasia groups, stroke groups, interest groups, other professionals) so that the psychosocial benefits of the group are maintained. Family members are also part of the program. The program culminates in a challenge day in which participants present what they have achieved in front of family and friends. Group-level data demonstrates that Aphasia LIFT yielded positive and enduring outcomes in language impairment, functional communication, and communication-related quality of life in individuals with aphasia.

The intervention arms are:

Usual care: Any aphasia therapy up to 12 months post stroke, delivered by typical speech pathology service providers in outpatient hospital setting or community based rehabilitation setting in the patients’ homes or centres.

LIFT: 3 week intensive program + 4 weeks maintenance, delivered by trained speech pathologists at The UQ CCRE Aphasia Clinic and other rehabilitation centres of our Partner Organisations. Participants in LIFT attend 10 x 60 minute sessions per week each of individual therapy, 5 x 60 minute sessions per week of computer-based therapy and 2 x 60 minute sessions per week of group therapy.
Intervention code [1] 288032 0
Rehabilitation
Comparator / control treatment
Usual speech pathology service provided to people with aphasia following a stroke, in south east Queensland. Current standard practice in speech pathology is for people with aphasia to have daily sessions with a speech pathologist whilst in inpatient care, usually on a one-to-one basis or in a group.
Once discharged from inpatient care, people in need of ongoing language therapy may have sessions up to three times a week, depending on their needs. This treatment is usually delivered over a number of months depending on the severity of the aphasia. Co-occurring psychosocial issues are dealt with on an 'as-needed' basis.
Control group
Active

Outcomes
Primary outcome [1] 290602 0
Content Information Units:
Connected speech is considered to have greater ecological validity compared to language battery tasks. Two samples of language will be elicited using standard narrative discourse stimuli (participants tell a story about a single picture and a picture sequence) and an interactional discourse sample (barrier task used to promote a dialogue but with controlled vocabulary). The content and efficiency of language will be measured by calculating the percentage of correct information units (CIUs) and CIUs/minute. The authors report interjudge reliability to be 90% and both %CIU’s and CIUs/minute were able to differentiate 20 people with aphasia from 20 without.
Timepoint [1] 290602 0
Baseline, post-treatment and 12 months post-onset of stroke.
Primary outcome [2] 290603 0
Assessment for Living with Aphasia:
The ALA is a self-rated aphasia-friendly assessment of the impact of aphasia on a person’s everyday life. It is based on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) framework, an adaptation of the World Health Organization's International Classification of Functioning, Disability, and Health for people with aphasia. The authors reported that the ALA is psychometrically sound, with analysis of 101 participants indicating good inter-rater reliability (Cronbach alpha 0.85).
Timepoint [2] 290603 0
Baseline, post-treatment and 12 months post-onset of stroke.
Secondary outcome [1] 304881 0
Comprehensive Aphasia Test:
The CAT assesses language performance across multiple modalities: comprehension of spoken language and written language, repetition, naming, reading and writing. Inter-rater reliability is good to excellent (ICC above 0.9 in 23/26 elements of the battery) and there were significant correlations showing good concurrent validity between the CAT subtests and related tests.
Timepoint [1] 304881 0
Baseline, post-treatment and 12 months post-onset of stroke.
Secondary outcome [2] 304882 0
Boston Naming Test:
The BNT assesses word-finding by confrontation naming of 60 line drawings of high to low frequency objects. It is a frequently used, quick test of confrontation naming. Probe tasks of both treated & untreated items that participants fail to name at baseline will be used to specifically measure the effect of treatment on naming and its generalization to untreated named items. Internal consistency for the 60-item version ranges from r = 0.78 to 0.96 across studies.
Timepoint [2] 304882 0
Baseline, post-treatment and 12 months post-onset of stroke.
Secondary outcome [3] 304883 0
Participant Satisfaction:
An aphasia-friendly semi-structured interview with satisfaction rating scales have been designed to elicit the views of participants with aphasia.
Timepoint [3] 304883 0
Post treatment.
Secondary outcome [4] 304884 0
Assessment of Quality of Life (AQoL-4D):
A 12-item questionnaire that measures quality of life on the domains Independent Living, Mental Health, Relationships, Senses. Cronbach’s Alpha for these domains range from a satisfactory correlation of 0.54 for Senses to 0.92 for Mental Health.
Timepoint [4] 304884 0
Baseline, post-treatment and 12 months post-onset of stroke.
Secondary outcome [5] 304885 0
Family members of people with aphasia:
Communicative Effectiveness Index (CETI) - The CETI is a proxy rated measure of functional communication of the person with aphasia. Construct validity was reported to be good since the CETI showed significant change in a recovering group of people with aphasia compared to a stable group of people with aphasia.
Timepoint [5] 304885 0
Baseline, post-treatment and 12 months post-onset of stroke
Secondary outcome [6] 304886 0
Family members of people with aphasia:
Bakas Caregiver Outcomes Scale - Family members and friends often report needing support. Family members’ outcomes will be measured using the Bakas Caregiver Outcomes Scale. Internal consistency (alpha = 0.90) and test-retest reliability (ICC = 0.66; 95% CI = 0.42-0.81) was satisfactory. Criterion-related validity was supported by correlations with the SF-36 (r = 0.32, p < .001) and a criterion variable measuring how caregivers' lives had changed (r = 0.67, p < .001).
Timepoint [6] 304886 0
Baseline, post-treatment and 12 months post-onset of stroke
Secondary outcome [7] 304887 0
Family members of people with aphasia:
Participant Satisfaction - A semi-structured interview with satisfaction rating scales have been designed to elicit the views of participants who are family members
Timepoint [7] 304887 0
Post-treatment
Secondary outcome [8] 304888 0
Treating speech pathologists:
Australian Therapy Outcome Measure (AUSTOMs) - To obtain a speech pathology perspective on outcomes of participants with aphasia across the ICF, the AusTOMs language rating scale will be used. This is a frequently used clinical outcome measure used by speech pathologists.
Timepoint [8] 304888 0
Baseline, post therapy and 12 months post-onset of stroke
Secondary outcome [9] 304906 0
Speech Pathology Stakeholders:
Semi-structured stakeholder interviews - people with an interest in aphasia rehabilitation ( e.g speech pathologists, people with aphasia, speech pathology managers) will be purposively sampled and interviewed following a short video and presentation about the LIFT program. An experienced qualitative researcher will use a semi-structured interview with participants to explore the barriers and enablers to implementing and sustaining change in use of both the LIFT components (intensive therapy, group therapy, family support, goal oriented therapy, computer-based therapy) and the LIFT program as a whole.
Timepoint [9] 304906 0
Ongoing throughout the study.

Eligibility
Key inclusion criteria
1. Participants with aphasia:

Confirmed stroke (medical chart) and confirmed aphasia using the Frenchay Aphasia Screening Test.
Score above cut-off on the Montreal Cognitive Assessment cognitive screen.
Willing to forego other speech therapy for the duration of the study and during follow-up
Able to toilet independently or with the assistance of an accompanying caregiver.
Requires at least 7 more weeks of therapy as reported by the referring speech pathologist
English language, hearing and vision sufficient for therapy as judged by the referring speech pathologist and the research assistant.

2. Family members/carers of participants with aphasia:

Able to speak English

3. Treating speech pathologists

Qualified practising speech pathologists, employed by either UQ or the partner hospitals, who are providing either LIFT or usual care to the people with aphasia in this study.

4. Speech pathology stakeholders

Speech pathology managers, speech pathologists and consumers (i.e. people with aphasia and their family members/carers)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with aphasia:

Co-existing neurological or mental health condition (e.g., dementia, severe depression)
Severe apraxia of speech or severe dysarthria
Global aphasia preventing completion of assessments tasks
Transition care patients who receive aphasia services at home on discharge from hospital

2. Family members/carers of people with aphasia:

Must not have dementia or other cognitive impairments
Must not have uncorrected vision or hearing impairments that will prevent participation

3. Treating speech pathologists

No exclusion criteria

4. Speech pathology stakeholders

No exclusion criteria

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)
Potential participants will be identified soon after admission to hospital with stroke by their treating speech pathologist. The site liaison speech pathologist will approach the participant and their family member/carer to discuss their involvement in the trial. If they indicate interest, consent will be obtained after adequate discussion and opportunity for consideration and asking questions.
All participants will continue to receive usual speech pathology care up to four months post-stroke, at which point they enter the study. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomization will be used in order to ensure balance between LIFT and usual care groups with respect to severity of aphasia (mild/moderate, severe) using the Frenchay Aphasia Screening Test (FAST) screening assessment. Randomization using a computer-generated list of random numbers will occur immediately after consent has been obtained and at least 2 weeks prior to discharge from hospital separately within each stratum (e.g. mild/moderate or severe stratum). To minimize the risk that different numbers of patients will be assigned to the LIFT and the usual care groups, blocked randomization of the patients will be used. Blocked randomization offers the advantage that at any point in the trial, there will be a balance in the number of patients assigned to A versus B.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Pragmatic-effectiveness trials are generally acknowledged to be most appropriate for studies of economic viability and this is the overall design for this study. It examines the effectiveness of LIFT in a parallel single blinded two arm stratified block randomization pragmatic trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
EFFICACY OF TREATMENT: Data will be analysed on an intention to treat basis. To evaluate the effectiveness of the LIFT intervention program over usual care, linear mixed models will be implemented. Linear mixed modelling will be able to examine whether changes in the outcomes of interest, all of which are on interval-scale, vary over time as well as across the two groups (LIFT and usual), after adjusting for the effects of any potential confounders (if any). An alpha level of 0.05 will be accepted as significant. The results of the linear mixed models will be presented in the form of odds ratios and their 95% confidence intervals

COST EFFECTIVENESS: A two-pronged economic analysis will be conducted. First, an analysis alongside the trial will display the costs against their benefits measured as units of improvement on the relevant scales for communication ability. A second analysis will define the cost against quality-adjusted life years (QALYs).

TRANSLATIONAL STUDY: (Putting LIFT into speech pathology practice) Content analysis will identify the factors influencing practice that will need to be addressed by a tailored strategy for successful implementation of LIFT. We will draw on current best evidence for practice change (e.g. Cochrane Effective Practice and Organisation of Care (EPOC) reviews and contemporary implementation research) and use a systematic, theory-informed approach to develop the strategy.

SAMPLE SIZE
People with aphasia (n=234):
Power calculations on the primary outcome measure of the Assessment for Living with Aphasia (ALA) have been calculated from the Phase 1 & 2 LIFT study and our collected unpublished longitudinal data from our current NHMRC grant (Project ID # 631464). It assumes usual care has occurred to 12 months post onset. To achieve a power of 80% with 5% level of significance in comparing the two groups (one tailed–LIFT intervention is more effective than the usual care) we need 186 subjects (93 per group) with an effect size of 0.3668. To account for an attrition rate of 25% to the 12 month follow up period, we need a total of 234 participants recruited into the study (117 per group). For CIUs, an effect size of 1.67 was calculated with n=12 (6 per group) using data from a study of usual aphasia therapy for reading. Since the sample size was much less & no other usual care comparison group was found that used CIUs as an outcome measure, the ALA power calculation was used.
Family members/carers of people with aphasia (n=234):
Each person with aphasia recruited to the study will have a participating family member or carer.
Treating speech pathologists (n=30-50):
This is an estimate, based on numbers of speech pathologists known to be working in recruiting hospitals.
Stakeholders (n=30):
The study is funded for 30 semi-structured interviews with speech pathology stakeholders. It was felt that this number allowed for sampling of a suitably broad range of viewpoints.

Total pool of participants = ~550

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1555 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 1556 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [3] 1557 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [4] 1558 0
Gold Coast Hospital - Southport
Recruitment hospital [5] 1559 0
Ipswich Hospital - Ipswich
Recruitment hospital [6] 1560 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 1561 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [8] 1562 0
Logan Hospital - Meadowbrook
Recruitment hospital [9] 1563 0
Beaudesert Hospital - Beaudesert
Recruitment hospital [10] 1564 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [11] 1565 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 288045 0
Government body
Name [1] 288045 0
National Health and Medical Research Council
Country [1] 288045 0
Australia
Primary sponsor type
Individual
Name
Professor Linda Worrall
Address
CCRE in Aphasia Rehabilitation
School of Health and Rehabilitation Sciences
Level 8, Therapies Building 84a
The University of Queensland
St Lucia
QLD 4072
Country
Australia
Secondary sponsor category [1] 286771 0
Individual
Name [1] 286771 0
Associate Professor David Copland
Address [1] 286771 0
CCRE in Aphasia Rehabilitation
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country [1] 286771 0
Australia
Secondary sponsor category [2] 286867 0
Individual
Name [2] 286867 0
Ms Melissa Lawrie
Address [2] 286867 0
Director of Speech Pathology
Gold Coast University Hospital
1 Hospital Boulevard
Southport, QLD 4125
Country [2] 286867 0
Australia
Secondary sponsor category [3] 286868 0
Individual
Name [3] 286868 0
Professor Elizabeth Ward
Address [3] 286868 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Country [3] 286868 0
Australia
Secondary sponsor category [4] 286869 0
Individual
Name [4] 286869 0
Doctor Moya Pattie
Address [4] 286869 0
Team Leader - Speech Pathology
The Wesley Hospital
P O Box 499
Toowong, QLD 4066
Country [4] 286869 0
Australia
Secondary sponsor category [5] 286870 0
Individual
Name [5] 286870 0
Doctor Asad Khan
Address [5] 286870 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Luca, QLD 4072
Country [5] 286870 0
Australia
Secondary sponsor category [6] 286871 0
Individual
Name [6] 286871 0
Doctor Jacob Veerman
Address [6] 286871 0
The University of Queensland School of Population Health
Public Health Building
Herston Road
Herston, QLD 4006
Country [6] 286871 0
Australia
Secondary sponsor category [7] 286872 0
Individual
Name [7] 286872 0
Doctor Denise O'Connor
Address [7] 286872 0
School of Public Health and Preventative Medicine
Monash University
Alfred Hospital
Melbourne, VIC 3800
Country [7] 286872 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289970 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 289970 0
Ethics committee country [1] 289970 0
Australia
Date submitted for ethics approval [1] 289970 0
13/09/2013
Approval date [1] 289970 0
18/10/2013
Ethics approval number [1] 289970 0
EC00167
Ethics committee name [2] 289971 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [2] 289971 0
Ethics committee country [2] 289971 0
Australia
Date submitted for ethics approval [2] 289971 0
24/09/2013
Approval date [2] 289971 0
Ethics approval number [2] 289971 0
EC00374
Ethics committee name [3] 289972 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [3] 289972 0
Ethics committee country [3] 289972 0
Australia
Date submitted for ethics approval [3] 289972 0
22/11/2013
Approval date [3] 289972 0
Ethics approval number [3] 289972 0
EC00179

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

Contacts
Principal investigator
Name 42762 0
Prof Linda Worrall
Address 42762 0
CCRE in Aphasia Rehabilitation
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country 42762 0
Australia
Phone 42762 0
+61 7 3365 2891
Fax 42762 0
Email 42762 0
l.worrall@uq.edu.au
Contact person for public queries
Name 42763 0
Renee Allan
Address 42763 0
CCRE in Aphasia Rehabilitation
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country 42763 0
Australia
Phone 42763 0
+61 7 3365 7595
Fax 42763 0
Email 42763 0
r.allan1@uq.edu.au
Contact person for scientific queries
Name 42764 0
Linda Worrall
Address 42764 0
CCRE in Aphasia Rehabilitation
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country 42764 0
Australia
Phone 42764 0
+61 7 3365 2891
Fax 42764 0
Email 42764 0
l.worrall@uqedu.au

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No Supporting Document Provided



Results publications and other study-related documents

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