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

This study has been completed.
Sponsor:
Information provided by:
NHS Health Technology Assessment Programme
ClinicalTrials.gov Identifier:
NCT00158106
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 7, 2005
September 7, 2005
February 2005
Not Provided
The primary outcome will be functional communicative ability.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Speech or Language Impairment Following Stroke
Procedure: Speech and Language therapy for dysarthria and/or aphasia
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00158106
HTA ref. 02/11/04, ISRCTN78617680, 04/MRE03/30
Not Provided
Not Provided
NHS Health Technology Assessment Programme
Not Provided
Principal Investigator: Audrey Bowen, PhD The University of Manchester, UK
NHS Health Technology Assessment Programme
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP