Speech or Language Impairment Following Stroke Clinical Trial
Official title:
Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.
Research Question: This is the pilot phase of a two-phase study. Phase 1 - What is the
feasibility of conducting a randomised controlled trial of therapy for adults with
post-stroke communication impairment? to be followed in 2006 by Phase 2 - What are the
effectiveness, costs and service user preferences, for the provision of speech and language
therapy for communication difficulties experienced by people in hospital with a stroke?
Methodology: Phase 1 - Qualitative (focus groups & individual interviews) and quantitative
(pilot RCT). Phase 2 - Qualitative (focus groups & individual interviews) and quantitative
(a pragmatic, multicentred, randomised controlled trial, stratified by diagnosis and
therapist/centre, using an 'intention to treat' approach). Discrete choice experiments will
be used to determine cost effectiveness.
Outcome Measures: The primary outcome will be functional communicative ability. The economic
analysis will estimate the incremental cost effectiveness and net benefit of the
intervention group compared to the control group from a societal perspective. The
qualitative study will examine service users' and carers' perspectives on the process and
effects of Speech and Language Therapy or the control treatment.
Sample Group: Adults with dysarthria or aphasia, seen early after admission to hospital with
a stroke. Exclusions: subarachnoid haemorrhage, progressive dementia, expected recovery
without therapy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training