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Sponsored by: |
University of Manchester |
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Information provided by: | University of Manchester |
ClinicalTrials.gov Identifier: | NCT00831740 |
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.
Condition | Intervention |
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Stroke |
Other: Speech and Language Therapy (SLT) Other: Attention Control |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ACT NoW: Assessing the Effectiveness of Communication Therapy in the North West: a Pragmatic, Multi-Centre Randomised Controlled Trial |
Estimated Enrollment: | 170 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Speech Therapy: Experimental |
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.
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ACT NoW Visitor: Active Comparator |
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Audrey Bowen, Dr | +44 (0) 161 275 3363 | audrey.bowen@manchester.ac.uk |
Contact: Emma Patchick | + 44 (0) 161 275 4964 | emma.patchick@manchester.ac.uk |
United Kingdom | |
The University of Manchester | Recruiting |
Manchester, United Kingdom, M13 9PL | |
Contact: Research Secretary + 44 (0) 161 275 3363 actnowstudy@manchester.ac.uk | |
Contact: Emma Patchick + 44 (0) 161 275 4964 emma.patchick@manchester.ac.uk | |
Principal Investigator: Audrey Bowen, Dr |
Study ID Numbers: | R011023, NIHR grant: 02/11/04, REC ref: 02/11/04, ISRCTN: 78617680 |
Study First Received: | January 28, 2009 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00831740 History of Changes |
Health Authority: | United Kingdom: Department of Health; United Kingdom: Research Ethics Committee |
Stroke Communication Speech and Language Therapy |
Cerebral Infarction Stroke Vascular Diseases |
Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders |
Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders |