Stroke Attention Rehabilitation Trial (START): Impact of Attention Process Training (APT) on Attention and Quality of Life

Phase 3

Completed

• Conditions: Stroke; Stroke -; Stroke - Ischaemic

• Registration Number: ACTRN12607000045415
• Lead Sponsor: Clinical Trials research Unit, faculty of Medical and Health Sciences, University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

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).

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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.[At Baseline, 5-weeks and 6-months];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.[At Baseline, 5-weeks and 6-months]

Secondary Outcome Measures

Name	Time	Method
stroke survivor<br>1. Bells Test<br>2. Trails A/B <br>3. Stroop test <br>4. Paced Auditory Serial Addition Test (PASAT)<br>5. SF-36[At Baseline, 5-weeks and 6-months];stroke survivor<br>6. Neuropsychological assessments of memory and language<br>7. the Modified Rankin Scale<br>8. General Health Questionnaire 28; see below for criteria) <br>9. Cognitive Failures Questionnaire[At Baseline and 6-months ];caregiver<br>10. SF-36<br>11. Bakas Caregiving Outcomes Scale[At Baseline and 6 months];Additional Outcomes to be assessed include Health Economics as indicated by service utilisation.[Costs assessed from baseline to 6 month follow-up]