NCT00831740

Brief Summary

Assessing Communication Therapy in the North West (ACT NoW) is a research project which aims to evaluate the effectiveness, cost effectiveness and service user preferences for communication therapy following stroke when compared to an attention control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 4, 2010

Status Verified

October 1, 2010

Enrollment Period

3.8 years

First QC Date

January 28, 2009

Last Update Submit

November 3, 2010

Conditions

Stroke

Keywords

StrokeCommunicationSpeech and Language Therapy

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be functional communicative ability

    6 months post randomisation

Secondary Outcomes (1)

  • The economic analysis to estimate incremental cost effectiveness and net benefit of the intervention. Qualitative study to examine service users' and carers' perspectives Speech and Language Therapy vs control treatment.

    6 months post randomisation

Study Arms (2)

Speech Therapy

EXPERIMENTAL
Other: Speech and Language Therapy (SLT)

ACT NoW Visitor

ACTIVE COMPARATOR
Other: Attention Control

Interventions

Speech and Language Therapy (SLT)OTHER

Participants randomised into the treatment arm will receive early SLT of up to three sessions per week for a maximum duration of 16 weeks. The SLT intervention has been developed by a team of expert Speech and Language Therapists according to 'Best Practice Standards'. The intervention procedure is manualised to allow replicability by other Speech Therapy Departments if it is shown to be effective.

Speech Therapy
Attention ControlOTHER

Those in the attention control arm of the trial will receive similar levels of contact as those in the SLT arm. However contact will be with an ACT NoW Visitor who has no specific knowledge about communication therapy. They will provide empathy and spend time with the patient, without any input from Speech and Language Therapists.

ACT NoW Visitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults diagnosed with aphasia and/or dysarthria following admission to hospital with a new stroke

You may not qualify if:

  • Subarachnoid haemorrhage
  • Pre-existing, progressive dementia or learning difficulties
  • Not able to receive therapy in the English language
  • Resident outside treatment area
  • Expected recovery without therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Related Publications (2)

  • 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 Dec;22(12):1083-94. doi: 10.1177/0269215508090091.

    PMID: 19052247BACKGROUND

  • Long A, Hesketh A, Bowen A; ACT NoW Research Study. Communication outcome after stroke: a new measure of the carer's perspective. Clin Rehabil. 2009 Sep;23(9):846-56. doi: 10.1177/0269215509336055. Epub 2009 May 29.

    PMID: 19482891BACKGROUND

MeSH Terms

Conditions

StrokeCommunicationCommunication Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

October 1, 2006

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

November 4, 2010

Record last verified: 2010-10

Locations

GB(1)