Clinical trial NCT00158106: Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
Official title: Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech or Language Impairment Following Stroke
Keywords: functional communicative ability
cost effectiveness
service user preferences
Lead sponsor: NHS Health Technology Assessment Programme
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.

Detailed description: Research Question: This is the pilot phase of 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? to be followed in 2006 by 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? Methodology: 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.

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.

Sample Group: Adults with dysarthria or aphasia, seen early after admission to hospital with a stroke. Exclusions: subarachnoid haemorrhage, progressive dementia, expected recovery without therapy.

Eligibility criteria: Inclusion Criteria:

* Adults with communication impairment following a new stroke

Exclusion Criteria:

* Not fluent in the English language
* Subarachnoid haemorrhage
* Pre-existing, progressive dementia or learning disability
* Palliative care only or deceased since admission
* Resident outside the treatment area

Primary outcomes:
measure: The primary outcome will be functional communicative ability.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester
Study officials:
affiliation: The University of Manchester, UK
name: Audrey Bowen, PhD
role: PRINCIPAL_INVESTIGATOR
References: