Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
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|ClinicalTrials.gov Identifier: NCT00158106|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
|Condition or disease||Intervention/treatment||Phase|
|Speech or Language Impairment Following Stroke||Procedure: Speech and Language therapy for dysarthria and/or aphasia||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)|
|Study Start Date :||February 2005|
|Study Completion Date :||August 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|