ACT NoW: Assessing the Effectiveness of Communication Therapy in the North West (ACT NoW)

November 3, 2010 updated by: University of Manchester

ACT NoW: Assessing the Effectiveness of Communication Therapy in the North West: a Pragmatic, Multi-centre Randomised Controlled Trial

Assessing Communication Therapy in the North West (ACT NoW) is a research project which aims to evaluate the effectiveness, cost effectiveness and service user preferences for communication therapy following stroke when compared to an attention control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is the leading cause of long-term disability in the UK. About a third of stroke survivors will suffer some level of communication problems following the stroke. Such problems can affect parts or all of the motor apparatus responsible for producing speech, thus affecting clarity of speech and overall intelligibility (a condition known as dysarthria). Alternatively, stroke can affect the cognitive system for comprehending and formulating language (a condition known as dysphasia or aphasia). Some people will suffer impairment of both speech and language.

For these people, Speech and Language Therapy is often offered. Solid research evidence is a pre-requisite for planning evidence-based service delivery and systematic reviews for dysarthria and aphasia highlighted a lack of good quality research evidence of the effectiveness of Speech and Language Therapy. To try and rectify this situation, the ACT NoW study has been commissioned and funded by the NIHR Health Technology Assessment Programme.

The aims of the ACT NoW Study are to determine the relative effectiveness and cost effectiveness of a Speech and Language Therapy (SLT) intervention for people with aphasia and/or dysarthria following stroke, when compared with an attention control. We also aim to explore the experience and the impact of the interventions from the perspective of both users and carers, using qualitative research.

The ACT NoW study is a pragmatic, multi-centre randomize controlled trial (RCT) with a nested qualitative study and full economic evaluation. The RCT involves comparison of two arms within this target population: a manualized Speech and Language Therapy (SLT) intervention; and an 'attention control'. Randomization will be stratified by diagnosis/severity as well as site/centre, with an 'intention to treat' approach.

The qualitative study will comprise interviews with patients and carers, purposefully sampled from each arm of the trial, to evaluate service user preferences for communication therapy after stroke. Innovative methods of communication support have been developed to enable people with communication difficulties to engage in the interview process.

The ACT NoW trial design was informed by a successful feasibility study.

We reached our target of 170 participants. This was the minimum we needed to achieve a powerful study. A fabulous achievement thanks to phenomenal dedication and hard work from everyone. Outcomes data were collect July 2010. Final data analysis is ongoing and results will be available from December 2010. Audrey Bowen, the study Chief Investigator will be presenting the results at the UK Stroke Forum in Glasgow (30th Nov- 2nd December 2010).

The results will be published in the NIHR HTA monograph and a short report on the results will be available from the study website: http://www.psych-sci.manchester.ac.uk/actnow/ Please check the study websites for updates.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9PL
        • The University of Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults diagnosed with aphasia and/or dysarthria following admission to hospital with a new stroke

Exclusion Criteria:

  • Subarachnoid haemorrhage
  • Pre-existing, progressive dementia or learning difficulties
  • Not able to receive therapy in the English language
  • Resident outside treatment area
  • Expected recovery without therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Speech Therapy
Other: Speech and Language Therapy (SLT)
Participants randomised into the treatment arm will receive early SLT of up to three sessions per week for a maximum duration of 16 weeks. The SLT intervention has been developed by a team of expert Speech and Language Therapists according to 'Best Practice Standards'. The intervention procedure is manualised to allow replicability by other Speech Therapy Departments if it is shown to be effective.
Active Comparator: ACT NoW Visitor
Other: Attention Control
Those in the attention control arm of the trial will receive similar levels of contact as those in the SLT arm. However contact will be with an ACT NoW Visitor who has no specific knowledge about communication therapy. They will provide empathy and spend time with the patient, without any input from Speech and Language Therapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be functional communicative ability
Time Frame: 6 months post randomisation
6 months post randomisation

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 months post randomisation
6 months post randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Estimate)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 3, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R011023
  • NIHR grant: 02/11/04
  • REC ref: 02/11/04
  • ISRCTN: 78617680

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Speech and Language Therapy (SLT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe