Condition category
Circulatory System
Date applied
08/08/2012
Date assigned
09/08/2012
Last edited
06/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One third of patients have long term disability after stoke but specialist stroke rehabilitation usually lasts no more than a few months. Patients who have on going rehabilitation needs once specialist stroke rehabilitation finishes may be referred to a range of other health care professionals or services, but most do not offer specialist stroke rehabilitation. One of the reasons that specialist stroke rehabilitation is not provided over a longer period is because it is not yet known if it is beneficial. This research project is a clinical trial to determine whether a new extended stroke rehabilitation service is beneficial to patients and carers.

Who can participate?
Adults aged over 18 with a new stroke who are being discharged from hospital after their stroke under the care of an Early Supported Discharge team. Carers of stroke patients may also participate. A carer is the main family member or friend, who will provide support after discharge. He/she may not necessarily live with the patient.

What does the study involve?
Stroke patients and carers who agree to participate in the trial will be randomly allocated to either receive a new extended stroke rehabilitation service or to continue with usual NHS care when routine specialist stroke rehabilitation (Early Supported Discharge) ends. The new extended stroke rehabilitation service will involve on going contact, usually by telephone, with a senior Early Supported Discharge (ESD) stroke therapist or nurse for 18 months after ESD finishes. The therapist/nurse will contact patients and carers at 1, 3, 6, 12 and 18 months after discharge from ESD to review their progress and rehabilitation needs. Rehabilitation goals will be agreed and the therapist/nurse will give advice on how to progress towards the goals. The advice may be verbal advice, for example, exercises to practice at home. Or, if required, referral for an additional period of therapy from a service which is available locally may be arranged. Usual NHS care following specialist stroke rehabilitation may involve referral to a range of rehabilitation services in accordance with local clinical practice. The effectiveness of the new extended rehabilitation service will be evaluated by comparing the health (e.g functional abilities and quality of life) of patients and carers who received the new service with those who received usual NHS care.

What are the possible benefits and risks of participating?
We do not know if providing a specialist stroke rehabilitation service over a longer period of time is beneficial. However, we do know that rehabilitation treatments early after stroke improve health and recovery. We believe that rehabilitation over a longer period of time may be beneficial, but this is not yet proven.

Where is the study run from?
The study is being run from Newcastle University, Newcastle upon Tyne, UK. Patients and carers from twelve or more NHS stroke services will be invited to take part.

When is the study starting and how long is it expected to run for?
Recruitment to the study will start on 01 January 2013 and end on 31 May 2015. Study follow up will end on 31 January 2017. The total duration of the study is 5 years.

Who is funding the study?
UK National Institute for Health Research - Health Technology Assessment Programme.

Who is the main contact?
Dr Lisa Shaw
Lisa.Shaw@ncl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lisa Shaw

ORCID ID

Contact details

Stroke Research Group
Institute for Ageing and Health
3-4 Claremont Terrace
Newcastle Upon Tyne
NE2 4AE
United Kingdom
+44 (0)191 222 6779
lisa.shaw@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12789

Study information

Scientific title

A trial to Evaluate an eXTended RehAbilitation service for Stroke patients (EXTRAS)

Acronym

EXTRAS

Study hypothesis

To determine the clinical and cost effectiveness of an extended stroke rehabilitation service.

Ethics approval

Newcastle and North Tyneside Research Ethics Committee, 25/06/2012, ref: 12/NE/0217

Study design

Randomised interventional phase III study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stroke Rehabilitation

Intervention

Study intervention: An extended stroke rehabilitation service provided for 18 months following completion of routine specialist stroke rehabilitation (Early Supported Discharge). The extended stroke rehabilitation service will provide on-going contact with a senior ESD team member who will lead and coordinate further rehabilitation.

Study control: Usual care post Early Supported Discharge. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Nottingham Extended Activities of Daily Living Scale at 24 months post randomisation.

Secondary outcome measures

For patients: health status (Oxford Handicap Scale), quality of life (Euroqol EQ-5D), mood (Hospital Anxiety and Depression Scale), experience of services and resource use (adaptation of the Client Service Receipt Inventory) at 12 and 24 months.

For carers: quality of life (Euroqol EQ-5D), carer stress (Caregiver Strain Index) and experience of services at 12 and 24 months.

Overall trial start date

01/01/2013

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Stroke patients:
1. Aged 18 years and over
2. Confirmed diagnosis of new stroke (first ever or recurrent)
3. Will be discharged from hospital under the care of an early supported discharge team

Stroke carers:
A carer is the main family member or friend, who will provide support after discharge. He/she may not necessarily be co-resident
with the patient.

If a stroke patient has no carer or the carer does not wish to participate in the study, the patient may still participate in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 510

Participant exclusion criteria

Stroke patients unable to participate in a rehabilitation programme which focuses upon extended activities of daily living.

Recruitment start date

01/01/2013

Recruitment end date

31/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Ageing and Health
Newcastle Upon Tyne
NE2 4AE
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust (UK)

Sponsor details

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.northumbria.nhs.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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25939584

Publication citations

Additional files

Editorial Notes