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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00158106     History of Changes
Other Study ID Numbers: HTA ref. 02/11/04, ISRCTN78617680, 04/MRE03/30
Study First Received: September 7, 2005
Last Updated: September 7, 2005
Health Authority: United Kingdom: Department of Health

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

Additional relevant MeSH terms:
Language Disorders
Stroke
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014