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Assessing the effectiveness of Communication Therapy in the North West
ISRCTN ISRCTN78617680
DOI 10.1186/ISRCTN78617680
ClinicalTrials.gov identifier NCT00831740
EudraCT number
Public title Assessing the effectiveness of Communication Therapy in the North West
Scientific title Assessing the effectiveness of Communication Therapy in the North West: a pragmatic, multicentre randomised controlled trial
Acronym ACT NoW
Serial number at source HTA 02/11/04
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.

Please note that, as of 17/01/2008, anticipated start and end dates of this trial have been updated from 01/06/2004 and 30/11/2007 to 01/10/2004 and 28/02/2010, respectively.

Please note that, as of 23/01/2009, extensive amendments have been made to this ISRCTN record. They include the following:
1. Anticipated end date of this trial has been amended from 28/02/2010 to 28/10/2010
2. The target number of participants has been amended from 600 to 170 (85 in each arm)
Other changes are recorded in the relevant fields.

Please note that the scientific title was added as of 28/01/2009.

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

Please note that as of 10/07/2009 this record was updated to include an extended anticipated end date; the previous anticipated end date was 28/10/2010.
Lay summary http://www.psych-sci.manchester.ac.uk/actnow/patients/
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
Countries of recruitment United Kingdom
Disease/condition/study domain Stroke
Participants - 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.
Participants - 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.
Anticipated start date 01/10/2004
Anticipated end date 31/10/2010
Status of trial Completed
Patient information material Patient information can be found at: http://www.psych-sci.manchester.ac.uk/actnow/patients/needtoknow/
Target number of participants 170 (85 in each arm)
Interventions Please note that as of 03/11/10 this trial has been completed.
Recruitment ended in February 2010. Final outcomes were collected in July 2010 and this data is currently being analysed.
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 (link below). Please check the study website for updates.

Speech and language therapy versus an attention control.

Added as of 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.
Primary outcome measure(s) 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 measure(s) Added as of 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
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.psych-sci.manchester.ac.uk/actnow/
Publications 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
Contact name Dr  Audrey  Bowen
  Address Human Communication & Deafness (HCD) Group
School of Psychological Sciences
University of Manchester
Ellen Wilkinson Building
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Tel +44 (0)161 275 3363
  Fax +44 (0)161 275 3373
  Email audrey.bowen@man.ac.uk
Sponsor University of Manchester (UK)
  Address Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Sponsor website: http://www.manchester.ac.uk/
Date applied 26/02/2004
Last edited 22/10/2012
Date ISRCTN assigned 27/02/2004
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