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

Primary Purpose

Speech or Language Impairment Following Stroke

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Speech and Language therapy for dysarthria and/or aphasia

About this trial

This is an interventional educational/counseling/training trial for Speech or Language Impairment Following Stroke focused on measuring functional communicative ability, cost effectiveness, service user preferences

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

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.

Full Information

NCT ID

NCT00158106

First Posted

September 7, 2005

Last Updated

September 7, 2005

Sponsor

NHS Health Technology Assessment Programme

1. Study Identification

Unique Protocol Identification Number

NCT00158106

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

NHS Health Technology Assessment Programme

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Speech or Language Impairment Following Stroke

Keywords

functional communicative ability, cost effectiveness, service user preferences

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Speech and Language therapy for dysarthria and/or aphasia

Primary Outcome Measure Information:

Title

The primary outcome will be functional communicative ability.

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Audrey Bowen, PhD

Organizational Affiliation

The University of Manchester, UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Manchester

ZIP/Postal Code

M13 9PL

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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