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

Not Applicable

Completed

• Conditions: Speech or Language Impairment Following Stroke

• Registration Number: NCT00158106
• Lead Sponsor: NHS Health Technology Assessment Programme

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.

Study Timeline

• Study Start: 2005-02
• Study Completion: 2005-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Last Update Submitted: 2005-09-07
• Study First Posted: 2005-09-12
• Last Update Posted: 2005-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome will be functional communicative ability.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester; 🇬🇧 Manchester, United Kingdom