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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: NHS Health Technology Assessment Programme

Current Primary Outcome: The primary outcome will be functional communicative ability.

Original Primary Outcome: Same as current

Current Secondary Outcome: 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.

Original Secondary Outcome: Same as current

Information By: NHS Health Technology Assessment Programme

Dates:
Date Received: September 7, 2005
Date Started: February 2005
Date Completion: August 2005
Last Updated: September 7, 2005
Last Verified: September 2005