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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:
ClinicalTrials.gov Identifier:
NCT00158106
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NHS Health Technology Assessment Programme
  Purpose
This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.

Condition Intervention
Speech or Language Impairment Following Stroke Procedure: Speech and Language therapy for dysarthria and/or aphasia

Study Type: Interventional
Study Design: 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)

Further study details as provided by NHS Health Technology Assessment Programme:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 60
Study Start Date: February 2005
Estimated Study Completion Date: August 2005
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158106


Locations
United Kingdom
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
  More Information

ClinicalTrials.gov Identifier: NCT00158106     History of Changes
Other Study ID Numbers: HTA ref. 02/11/04
ISRCTN78617680
04/MRE03/30
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by NHS Health Technology Assessment Programme:
functional communicative ability
cost effectiveness
service user preferences

Additional relevant MeSH terms:
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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