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Trial registered on ANZCTR


Registration number
ACTRN12607000045415
Ethics application status
Approved
Date submitted
26/10/2006
Date registered
12/01/2007
Date last updated
8/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Stroke Attention Rehabilitation Trial (START): Impact of Attention Process Training (APT) on Attention and Quality of Life
Scientific title
A randomised phase III study to evaluate the effectiveness of Attention Process Training (APT-I) in reducing attention deficits in people who recently suffered a stroke
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 1538 0
Condition category
Condition code
Stroke 1636 1636 0 0
Stroke 5019 5019 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial will examine the effectiveness of implementing an attention rehabilitation programme, Attention Process Training I (APT- I), by comparing two groups of persons who have recently suffered a stroke: those who receive APT with those who receive standard care. Those who recieve APT will also recieve standard care. Average duration of standard care is 3 weeks.
APT materials consist of a group of hierarchically organised tasks that exercise different components of attention, including sustained, selective, alternating, and divided attention. As an individual moves through the program the tasks place increasing demands on complex attention control. The program activities are not functional and resemble laboratory tasks. This is because most functional tasks (e.g., meal planning) are multifaceted and require activation of many different cognitive processes. Use of discrete attention tasks allows stimulation of isolated components of attention. Examples of APT activities identified by the authors of the intervention, Sohlberg and Mateer, that correspond to the different facets of attention are: (1) Sustained Attention: listening for target words or sequences within an array and pressing a button when the target is identified, listening to paragraphs and showing comprehension of content, and mental arithmetic; (2) Alternating Attention: Exercises that require listening for one type of target word or sequence and then switching to listening for a different type of word or sequence mid-way through the task, paper-and–pencil tasks that require alternating between generating numbers and letters that come before or after a presented target,; (3) Selective attention: Completion of sustained attention tasks with the addition of distractor noise or movement, completion of paper-and-pencil tasks with the addition of visual distracters (i.e., transparent overlays); (4) Divided Attention: reading paragraphs for comprehension while simultaneously scanning for a target word (i.e., counting the number of times “and” appears), completing a sustained attention activity while simultaneously tracking elapsed time.
A maximum of 30 hours of APT is to be provided in one-to-one sessions daily (weekdays). Sessions will occur once daily and be 90 minutes in length (with a mid-session break) and be conducted over 4 weeks. Clients are typically discharged after 3 weeks of inpatient rehabilitation. Those discharged before the end of the APT intevention will be followed-up for treatment and assessment at place of discharge.
Standard care includes daily sessions of occupational and physiotherapy, and other therapies (e.g., speech therapy) as required, and will be provided to both groups. In order that the provision of any other interventions that impact attention can be determined, all other rehabilitation interventions provided will be monitored in both groups until the end of the study (i.e., 6-months post-randomisation).
Intervention code [1] 1419 0
Rehabilitation
Comparator / control treatment
To receive standard care. Standard care includes daily sessions of occupational and physiotherapy, and other therapies (e.g., speech therapy) as required.
Control group
Active

Outcomes
Primary outcome [1] 2257 0
1. Integrated Visual & Auditory Continuous Performance Test (IVA-CPT), a computerised continuous performance test that provides indices of attention to both auditory and visual stimuli.
The IVA Attention Quotient will be the primary outcome used to gauge improvements in attention. Significant change on neuropsychological tests will be defined as one standard deviation.
Timepoint [1] 2257 0
At Baseline, 5-weeks and 6-months
Primary outcome [2] 2258 0
2. Mental Component Summary (MCS) score on the Medical Outcomes Study 36-item short Form questionnair (SF-36) - a measure of health related quality of life.
Timepoint [2] 2258 0
At Baseline, 5-weeks and 6-months
Secondary outcome [1] 3931 0
stroke survivor
1. Bells Test
2. Trails A/B
3. Stroop test
4. Paced Auditory Serial Addition Test (PASAT)
5. SF-36
Timepoint [1] 3931 0
At Baseline, 5-weeks and 6-months
Secondary outcome [2] 3932 0
stroke survivor
6. Neuropsychological assessments of memory and language
7. the Modified Rankin Scale
8. General Health Questionnaire 28; see below for criteria)
9. Cognitive Failures Questionnaire
Timepoint [2] 3932 0
At Baseline and 6-months
Secondary outcome [3] 3933 0
caregiver
10. SF-36
11. Bakas Caregiving Outcomes Scale
Timepoint [3] 3933 0
At Baseline and 6 months
Secondary outcome [4] 3934 0
Additional Outcomes to be assessed include Health Economics as indicated by service utilisation.
Timepoint [4] 3934 0
Costs assessed from baseline to 6 month follow-up

Eligibility
Key inclusion criteria
1.Newly diagnosed stroke (first-ever-in-a-lifetime stroke)2.Attention Deficit identified (defined as Bells test has at least 3 errors; PASAT or Trails A or Trails B = 0.5 [i.e. half a SD below the mean]; or IVA-CPT attention quotient, visual attention quotient or auditory quotient is = 90 [i.e 1 SD below Z -1.0 or Q < 90]). 3.Fluent in English (can converse, as standardised administration of tests requires English fluency).
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Cognitive deficit precluding participation precluding participation in APT (Mini-Mental State Examination Score < 20 );2.Unable to give informed consent; 3.Not considered medically stable (e.g., kidney/heart failure) in the opinion of a medical clinician (i.e., not referred for rehabilitation); 4.Known to have another condition that could impact assessment findings or ability to complete APT (e.g., drug abuse, alcoholism, mental illness) in the opinion of a medical clinician;5.Participation in another study that, in the opinion of the investigator, may affect cognitive performance or add significantly to participant burden.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation - Factors: sex, age (<70, =70), ethnicity (Pakeha, Non-pakeha), disability - Barthel (18 and above (high) or below 18 (very high), and site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Assessor, study manager, investigators, and data analyst are blinded to group assignment.
Phase
Phase 3
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 outside Australia
Country [1] 413 0
New Zealand
State/province [1] 413 0

Funding & Sponsors
Funding source category [1] 1782 0
Government body
Name [1] 1782 0
New Zealand Health Research Council
Address [1] 1782 0
Health Research Council of New Zealand
PO box 5441 Wellesley Street
Auckland 1141
New Zealand
Country [1] 1782 0
New Zealand
Primary sponsor type
University
Name
Clinical Trials research Unit, faculty of Medical and Health Sciences, University of Auckland
Address
The University of Auckland-Tamaki Campus
261 Morrin Road
Glen Innes
Private Bag 92019
Auckland 1141
New Zealand
Country
New Zealand
Secondary sponsor category [1] 1589 0
None
Name [1] 1589 0
n/a
Address [1] 1589 0
Country [1] 1589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3341 0
Northern Regional X ethics committee with Locality approval for both Middlemore Hospital and North Shore Hospital sites
Ethics committee address [1] 3341 0
Northern regional X Ethics Committee
Private Bag 92-522, Wellesley St
Auckland

Courier address:
3rd floor, Unisys building
650 Great South Rd
Penrose
Auckland
Ethics committee country [1] 3341 0
New Zealand
Date submitted for ethics approval [1] 3341 0
Approval date [1] 3341 0
01/10/2006
Ethics approval number [1] 3341 0
NTX/06/10/124

Summary
Brief summary
Approximately half of all individuals who have a stroke experience subsequent cognitive difficulties (e.g., memory, attention). Yet, post-stroke rehabilittaion has traditionally focussed on physical therapy and speech/language rehabilitation, with relatively little focus on improving the most common cognitive problem after stroke - impaired attention. Attention problems have a negative impact on functional outcomes (e.g., quality of life). There is evidence from several small studies, mostly in people with Traumatic brain Injury, that attention training can positively impact on functional outcomes. This randomised controlled trial will examine the effectiveness of implementing an attention rehabilitation programme, Attention Process training (APT-I) , by comparing two groups of persons who have recently suffered a stroke: those who recieve APT, and those who recieve standard care. Outcome measures will include attention deficits and other neuropsychological impairments, quality of life, levels of disability and handicap, and cost-effectiveness of the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27353 0
Address 27353 0
Country 27353 0
Phone 27353 0
Fax 27353 0
Email 27353 0
Contact person for public queries
Name 10608 0
Suzanne Barker-Collo
Address 10608 0
Department of Psychology
The University of Auckland
Private Bag 92019
Auckland
Country 10608 0
New Zealand
Phone 10608 0
+64 9 373-7599 ext 88517 or 86875
Fax 10608 0
+64 9 373-7450
Email 10608 0
s.barker-collo@auckland.ac.nz
Contact person for scientific queries
Name 1536 0
Associate Professor Valery Feigin
Address 1536 0
Director; National research centre for Stroke Applied neuroscience and neurorehabilitation
Auckland University of Technology
North Shore Campus
AA263, 90 Akoranga Dr, Northcote 0627
Private Bag 92006, Auckland 1142
Country 1536 0
New Zealand
Phone 1536 0
+ 64 9 921- 9166
Fax 1536 0
Email 1536 0
valery.feigin@aut.ac.nz

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