Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
Speech or Language Impairment Following Stroke
Procedure: Speech and Language therapy for dysarthria and/or aphasia
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|Official Title:||Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)|
- The primary outcome will be functional communicative ability.
- The economic analysis to estimate incremental cost effectiveness and net benefit of the intervention. Qualitative study to examine service users' and carers' perspectives Speech and Language Therapy vs control treatment.
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||August 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158106
|Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester|
|Manchester, United Kingdom, M13 9PL|
|Principal Investigator:||Audrey Bowen, PhD||The University of Manchester, UK|