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

Sponsor
NHS Health Technology Assessment Programme (Other)
Overall Status
Completed
CT.gov ID
NCT00158106
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Speech and Language therapy for dysarthria and/or aphasia
N/A

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Educational/Counseling/Training
Official Title:
Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
Study Start Date :
Feb 1, 2005
Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

  1. The primary outcome will be functional communicative ability. []

Secondary Outcome Measures

  1. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester Manchester United Kingdom M13 9PL

Sponsors and Collaborators

  • NHS Health Technology Assessment Programme

Investigators

  • Principal Investigator: Audrey Bowen, PhD, The University of Manchester, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00158106
Other Study ID Numbers:
  • HTA ref. 02/11/04
  • ISRCTN78617680
  • 04/MRE03/30
First Posted:
Sep 12, 2005
Last Update Posted:
Sep 12, 2005
Last Verified:
Sep 1, 2005
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 12, 2005