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

Speech or Language Impairment Following Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158106
• Other study ID #: HTA ref. 02/11/04
• Secondary ID: ISRCTN7861768004
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: September 7, 2005
• Start date: February 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: NHS Health Technology Assessment Programme
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Language Disorders
• Speech or Language Impairment Following Stroke

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
NHS Health Technology Assessment Programme

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be functional communicative ability.
Secondary	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.