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

NCT ID: NCT00158106

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Speech or Language Impairment Following Stroke

Keywords

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functional communicative ability cost effectiveness service user preferences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Speech and Language therapy for dysarthria and/or aphasia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Health Technology Assessment Programme

OTHER

Sponsor Role lead

Principal Investigators

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Audrey Bowen, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Manchester, UK

Locations

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Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ISRCTN78617680

Identifier Type: -

Identifier Source: secondary_id

04/MRE03/30

Identifier Type: -

Identifier Source: secondary_id

HTA ref. 02/11/04

Identifier Type: -

Identifier Source: org_study_id