Condition category
Circulatory System
Date applied
26/02/2004
Date assigned
27/02/2004
Last edited
06/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.manchester.ac.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes