Assessing the effectiveness of Communication Therapy in the North West
ISRCTN | ISRCTN78617680 |
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DOI | https://doi.org/10.1186/ISRCTN78617680 |
ClinicalTrials.gov number | NCT00831740 |
Secondary identifying numbers | HTA 02/11/04 |
- Submission date
- 26/02/2004
- Registration date
- 27/02/2004
- Last edited
- 06/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Audrey Bowen
Scientific
Scientific
Human Communication & Deafness (HCD) Group
School of Psychological Sciences
University of Manchester
Ellen Wilkinson Building
Manchester
M13 9PL
United Kingdom
Phone | +44 (0)161 275 3363 |
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audrey.bowen@man.ac.uk |
Study information
Study design | Pragmatic multi-centre randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Patient information can be found at: http://www.psych-sci.manchester.ac.uk/actnow/patients/needtoknow/ |
Scientific title | Assessing the effectiveness of Communication Therapy in the North West: a pragmatic, multicentre randomised controlled trial |
Study acronym | ACT NoW |
Study objectives | 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(s) | 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) |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/10/2004 |
Completion date | 31/10/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 170 (85 in each arm) |
Key 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. |
Key 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. |
Date of first enrolment | 01/10/2004 |
Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Human Communication & Deafness (HCD) Group
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
Website | http://www.manchester.ac.uk/ |
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https://ror.org/027m9bs27 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
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. |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results of assessment of the reliability of procedure for rating a conversation sample | Yes | No | ||
Results article | results on validation of Communication Outcome after Stroke (COAST) scale | 01/12/2008 | Yes | No | |
Other publications | evaluation | 01/05/2012 | Yes | No | |
Results article | results | 13/07/2012 | Yes | No |