M Rose

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

BackgroundPeople with aphasia and their family members are at high risk of experiencing postxa0stroke depression. The impact of early interventions on mood and quality of life for people with aphasia is unknown.Methods/designThis study will determine whether an early intervention for both the person with aphasia after stroke and their family members leads to better mood and quality of life outcomes for people with aphasia, and less caregiver burden and better mental health for their family members. This is a multicenter, cluster-randomized controlled trial. Clusters, which are represented by Health Service Districts, will be randomized to the experimental intervention (Aphasia Action Success Knowledge Program) or an attention control (Secondary Stroke Prevention Information Program). People with aphasia and their family members will be blinded to the study design and treatment allocation (that is, will not know there are two arms to the study). Both arms of the study will receive usual care in addition to either the experimental or the attention control intervention. A total of 344 people with aphasia and their family members will be recruited. Considering a cluster size of 20, the required sample size can be achieved from 18 clusters. However, 20 clusters will be recruited to account for the potential of cluster attrition during the study. Primary outcome measures will be mood and quality of life of people with aphasia at 12xa0months postxa0stroke. Secondary measures will be family member outcomes assessing the impact of caregiving and mental health, and self-reported stroke risk-related behaviors of people with aphasia.DiscussionThis is the first known program tailored for people with aphasia and their family members that aims to prevent depression in people with aphasia by providing intervention early after the stroke.Trial registrationThis trial is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as ACTRN12614000979651. Date registered: 11 September 2014.

A randomized controlled trial of very early rehabilitation in speech after stroke

Rationale The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. Aims and hypothesis The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC. Sample size estimates A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of αu2009=u20090.05. Setting Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014–2017. Design Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. Participants Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). Randomization Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. Intervention All participants receive UC—usual ward-based aphasia therapy. Arm 1: UC—no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy—a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45–60u2009min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke. Study outcome measures The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks. Economic evaluation Incremental cost-effectiveness ratios at 26 weeks will be reported. Discussion This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population.