Assessing the effectiveness of Communication Therapy in the North West

ISRCTN ISRCTN78617680
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

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

Study website

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

Study designPragmatic multi-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Patient information can be found at: http://www.psych-sci.manchester.ac.uk/actnow/patients/needtoknow/
Scientific titleAssessing the effectiveness of Communication Therapy in the North West: a pragmatic, multicentre randomised controlled trial
Study acronymACT NoW
Study objectivesThis 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) studiedStroke
InterventionSpeech 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 typeBehavioural
Primary outcome measureCurrent 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 measuresAdded 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 date01/10/2004
Completion date31/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants170 (85 in each arm)
Key inclusion criteriaCurrent 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 criteriaCurrent 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 enrolment01/10/2004
Date of final enrolment01/02/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Human Communication & Deafness (HCD) Group
Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Website http://www.manchester.ac.uk/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planResults 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?
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