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

Stroke Clinical Trial

— ACT NoW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831740
• Other study ID #: R011023
• Secondary ID: NIHR grant: 02/1
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: November 3, 2010
• Start date: October 2006
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Long A, Hesketh A, Bowen A; ACT NoW Research Study. Communication outcome after stroke: a new measure of the carer's perspective. Clin Rehabil. 2009 Sep;23(9):846-56. doi: 10.1177/0269215509336055. Epub 2009 May 29. Erratum in: Clin Rehabil. 2010 Apr;24(4):383. — View Citation

Long A, Hesketh A, Paszek G, Booth M, Bowen A. Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale. Clin Rehabil. 2008 Dec;22(12):1083-94. doi: 10.1177/0269215508090091. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be functional communicative ability		6 months post randomisation	No
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.		6 months post randomisation	No

External Links

•   Study Website