Assessing the effectiveness of Communication Therapy in the North West

ISRCTN	ISRCTN78617680
DOI	https://doi.org/10.1186/ISRCTN78617680
ClinicalTrials.gov (NCT)	NCT00831740
Protocol serial number	HTA 02/11/04
Sponsor	University of Manchester (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

http://www.psych-sci.manchester.ac.uk/actnow/patients/

Contact information

Dr Audrey Bowen
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
Email	audrey.bowen@man.ac.uk

Study information

Primary study design	Interventional
Study design	Pragmatic multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(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.
Key secondary outcome measure(s)	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
Completion date	31/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	170
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

United Kingdom
England

Study participating centre

Human Communication & Deafness (HCD) Group

Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Results article	results	13/07/2012		Yes	No
Other publications	evaluation	01/05/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes