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Clinical Trials/NCT00158106
NCT00158106
Completed
N/A

Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)

NHS Health Technology Assessment Programme1 site in 1 country60 target enrollmentFebruary 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Speech or Language Impairment Following Stroke
Sponsor
NHS Health Technology Assessment Programme
Enrollment
60
Locations
1
Primary Endpoint
The primary outcome will be functional communicative ability.
Status
Completed
Last Updated
20 years ago

Overview

Brief Summary

This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.

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.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
August 2005
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
NHS Health Technology Assessment Programme

Eligibility Criteria

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

Outcomes

Primary Outcomes

The primary outcome will be functional communicative ability.

Secondary Outcomes

  • 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 Sites (1)

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