Contact information
Type
Scientific
Primary contact
Dr Audrey Bowen
ORCID ID
Contact details
Human Communication & Deafness (HCD) Group
School of Psychological Sciences
University of Manchester
Ellen Wilkinson Building
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 3363
audrey.bowen@man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00831740
Protocol/serial number
HTA 02/11/04
Study information
Scientific title
Assessing the effectiveness of Communication Therapy in the North West: a pragmatic, multicentre randomised controlled trial
Acronym
ACT NoW
Study hypothesis
This is 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?
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?
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.
Details of the study can also be found at: http://www.hta.ac.uk/1390
Protocol can be found at: http://www.ncchta.org/protocols/200200110004.pdf
The ACT NoW Pilot Study is registered with ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00158106
On 17/01/2008 the overall trial start and end dates were changed from 01/06/2004 and 30/11/2007 to 01/10/2004 and 28/02/2010, respectively.
On 23/01/2009 the following changes were made to the trial record:
1. The overall trial end date was changed from 28/02/2010 to 28/10/2010.
2. The target number of participants has been changed from 600 to 170 (85 in each arm).
On 28/01/2009 the scientific title was added.
On 10/07/2009 the overall trial end date was changed from 28/10/2010 to 31/10/2010.
Ethics approval
Northern and Yorkshire Research Ethics Committee
Phase 1: granted 14/09/2004 (ref: 04/MRE03/30)
Phase 2: granted 14/07/2006 (ref: 06/MRE03/42)
Study design
Pragmatic multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.psych-sci.manchester.ac.uk/actnow/patients/needtoknow/
Condition
Stroke
Intervention
Speech and language therapy versus an attention control.
Added 06/02/2009: Duration of intervention depends on each patient; the maximum duration is 16 weeks. The intervention period will be followed by an 8-week 'break'/ retention period.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Current primary outcome measures as of 28/01/2009:
The following will be assessed 6 months after randomisation:
1. Functional communicative ability. Blinded expert therapists will rate semi-structured conversation using the Therapy Outcomes Measures (TOMS) scale.
2. Economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. Carers will self-complete the ACT NoW 'Support for Others Questionnaire' and research assistants will gather data for participant health economics evaluation through hospital records.
3. Qualitative study will examine service users' and carers' perspectives on the process and effects of Speech and Language Therapy or the control treatment. These will be assessed using qualitative interview schedules including rating scales developed specifically for this trial.
Previous primary 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.
Secondary outcome measures
Added 28/01/2009:
The following will be assessed 6 months after randomisation:
1. Quality of life, assessed by Euroqol EQ-5D
2. Patients and carers self-reported ratings of functional communicative ability as measured by the Communication Outcome After Stroke (COAST) scale
Overall trial start date
01/10/2004
Overall trial end date
31/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 23/01/2009:
Adults diagnosed with aphasia and/or dysarthria following admission to hospital with a stroke.
Previous inclusion criteria:
Adults diagnosed with aphasia or dysarthria following admission to hospital with a stroke.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
170 (85 in each arm)
Participant exclusion criteria
Current exclusion criteria as of 23/01/2009:
1. Subarachnoid haemorrhage
2. Progressive dementia/ learning difficulties
3. Not able to receive therapy in the English language
4. Expected recovery without therapy
Previous exclusion criteria:
Subarachnoid haemorrhage, progressive dementia, expected recovery without therapy.
Recruitment start date
01/10/2004
Recruitment end date
01/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Human Communication & Deafness (HCD) Group
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be publicly available from December 2010 - the Chief Investigator, Audrey Bowen will be giving an invited presentation on the results at the UK Stroke Forum in Glasgow (30th November - 2nd Dec).
The results will be published in the NIHR HTA monograph and a short report on the results will be available from the study website. Please check the study website for updates.
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 results of assessment of the reliability of procedure for rating a conversation sample in http://www.informaworld.com/smpp/content~content=a793360179
2. 2008 results on validation of Communication Outcome after Stroke (COAST) scale in http://www.ncbi.nlm.nih.gov/pubmed/19052247
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22797843
4. 2012 evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22613690
Publication citations
-
Results
Bowen A, Hesketh A, Patchick E, Young A, Davies L, Vail A, Long AF, Watkins C, Wilkinson M, Pearl G, Ralph MA, Tyrrell P, Effectiveness of enhanced communication therapy in the first four months after stroke for aphasia and dysarthria: a randomised controlled trial., BMJ, 2012, 345, e4407.
-
Evaluation
Bowen A, Hesketh A, Patchick E, Young A, Davies L, Vail A, Long A, Watkins C, Wilkinson M, Pearl G, Lambon Ralph M, Tyrrell P, , Clinical effectiveness, cost-effectiveness and service users' perceptions of early, well-resourced communication therapy following a stroke: a randomised controlled trial (the ACT NoW Study)., Health Technol Assess, 2012, 16, 26, 1-160, doi: 10.3310/hta16260.
-
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, 22, 12, 1083-1094, doi: 10.1177/0269215508090091.