Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manchester, United Kingdom, M13 9PL
- Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults with communication impairment following a new stroke
Exclusion Criteria:
- Not fluent in the English language
- Subarachnoid haemorrhage
- Pre-existing, progressive dementia or learning disability
- Palliative care only or deceased since admission
- Resident outside the treatment area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome will be functional communicative ability.
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
Investigators
- Principal Investigator: Audrey Bowen, PhD, The University of Manchester, UK
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTA ref. 02/11/04
- ISRCTN78617680
- 04/MRE03/30
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