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

N

NHS Health Technology Assessment Programme

Status

Completed

Conditions

Speech or Language Impairment Following Stroke

Treatments

Procedure: Speech and Language therapy for dysarthria and/or aphasia

Study type

Interventional

Funder types

Other

Identifiers

NCT00158106
HTA ref. 02/11/04
04/MRE03/30
ISRCTN78617680

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Educational/Counseling/Training

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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