Assessing the Effectiveness of Communication Therapy in the North West - The ACT NoW Study.

Abstract

The ACTNoW study is a randomised controlled trial and qualitative study evaluating the effectiveness, cost-effectiveness and service user preferences for communication therapy after stroke.

Background

Stroke is the leading cause of long-term disability in the UK. Each year, 130,000 people suffer a stroke in England and Wales. At any time, 250,000 people in the UK live with severe disability following a stroke.

About a third of stroke survivors will suffer some level of communication problems following the stroke. Such problems can affect parts or all of the motor apparatus responsible for producing speech, thus affecting clarity of speech and overall intelligibility (a condition known as dysarthria). Alternatively, stroke can affect the cognitive system for comprehending and formulating language (a condition known as dysphasia or aphasia). Some people will suffer impairment of both speech and language (dysarthria and aphasia). Communication problems can seriously affect a person’s confidence by limiting social participation and leading to social exclusion.

Services for communication problems following stroke vary greatly across the country and are chronically underfunded. There is no national minimum standard and the overall picture of service delivery is patchy at best. Solid research evidence is a pre-requisite for planning service delivery.

Aims

The HTA want answers to a very specific question: "What is the effectiveness and cost-effectiveness of speech and language therapy for dysphasia and/or dysarthria following stroke?" The brief further requests that the question be investigated using an RCT of "speech and language therapy strategies…effective yet feasible for routine NHS delivery” versus “attention control involving patient contact but not specific therapy".

Participants

Across the recruitment centres, NHS speech and language therapists will assess all people admitted to hospital with a new stroke for presence or absence of communication difficulties. Communication problems can be of varying severity but must consist of either aphasia, dysarthria or a combination of the two. Once consent has been given, newly recruited patients are randomised into either therapy intervention or an attention control delivered by paid 'Visitors'.

Intervention

The group is testing the effectiveness of an early therapy intervention, delivered by NHS therapists. Patients randomised into the treatment arm will receive therapy of up to three sessions per week for a maximum duration of 16 weeks. People in the control arm will receive a similar level of contact with a 'visitor'. Visitors are paid part-time staff who are trained to deliver a manualised attention control and are regularly monitored to ensure adherence to the research protocol.

Main phase

Having successfully completed a feasibility study across four centres in the North West, the group is going ahead with the main study. The main study consists of three parts:

• a randomised controlled trial
• a qualitative study of patient and carer preferences
• a health economic assessment.

Funding body

The NHS Health Technology Assessment Programme (HTA) is funding the study. The HTA is the sector of the NHS dealing with assessing performance in order to plan future service delivery and to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most effective way for those who use, manage and provide care in the NHS.