Condition category
Circulatory System
Date applied
30/01/2007
Date assigned
30/04/2007
Last edited
29/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.tracstrial.co.uk

Contact information

Type

Scientific

Primary contact

Dr Anne Forster

ORCID ID

Contact details

Academic Unit of Elderly Care and Rehabilitation
Temple Bank House
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 383 406/401
a.forster@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

470772, G0501807

Study information

Scientific title

Training Caregivers after Stroke (TRACS): a cluster randomised controlled trial of a structured training programme for caregivers of in-patients after stroke

Acronym

TRACS

Study hypothesis

The hypothesis for TRACS, based on results from a previous single centre study, is that a competency based caregiver-training programme (The London Stroke Carer Training Course, LSCTC) should improve patient outcomes in patients with disabling stroke. The study aims to evaluate the clinical and cost effectiveness of the training programme (LSCTC) by embedding it in usual practise to test the wider generalisability in settings where the population, health and social care provision differ.

Please note that as of 19/03/2008 this record was extensively updated. All changes are shown under the relevant fields with the date of change noted as 19/03/2008. Please also note that the anticipated start and end dates of this trial have been updated to the dates mentioned below. The previous trial dates were as follows:
Previous anticipated start date: 01/04/2007
Previous anticipated end date: 31/10/2010

Please note that as of 08/02/10 this trial has been extended from 31/10/10 to 31/08/11

Ethics approval

Favourable ethical opinion received from the Leeds (West) Research Ethics Committee on 2nd February 2007. Ref: 07/Q1205/12

Study design

Pragmatic multicentre cluster randomised controlled trial with blinded follow-up

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Disabling Stroke

Intervention

Current interventions as of 19/03/2008:
This is a cluster, randomised, controlled trial and aims to recruit 900 patients and caregivers in 36 stroke rehabilitation units. The intervention developed by Kalra and colleagues is known as the London Stroke Carer Training Course (LSCTC) and comprises a number of carer training sessions, competency assessment and one follow up session after discharge. The multidisciplinary teams (MDTs) in the units randomised to the intervention group will be trained to deliver the LSCTC, whilst those randomised to the control group will continue to provide usual care as per the National Guidelines.

Stroke rehabilitation units randomised to the control group will continue to provide usual care as per the National Guidelines for Stroke.

Previous interventions:
Stroke units will be randomised into intervention or control groups using the stratification factors of geographical site and quality of care.

Caregivers of inpatients in stroke rehabilitation units randomised to the intervention group will receive the London Stroke Carer Training Course (LSCTC) programme. Caregivers will receive 3-5 caregiver training sessions (depending on need) lasting 30-45 minutes, competency assessment and one home visit. Multidisciplinary teams in these stroke units will be trained to deliver the intervention.

Stroke rehabilitation units randomised to the control group will continue to provide usual care as per the National Guidelines for Stroke.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Current primary outcome measure(s) as of 19/03/2008:
Patient: Nottingham Extended Activities of Daily Living (NEADL)
Caregiver: Caregivers Burden Scale
Primary outcomes are measured at six months after recruitment.

Previous primary outcome measure(s):
The primary outcome is Nottingham Extended Activities of Daily Living (NEADL) for patients at 6 months after recruitment.

Secondary outcome measures

Current secondary outcome measure(s) as of 19/03/2008:
Patient:
1. Hospital Anxiety and Depression Scale (HADS) (mood)
2. Euro-quality of life (EQ-5D) (health state)
3. Barthel Index (activities of daily living)
4. Death
5. Institutionalisation
6. Re-admission
7. Stroke Impact Scale (functional ability and health related quality of life)
8. Costs based on Client Service Receipt Inventory

Caregiver:
1. Compliance with intervention
2. Frenchay activities index (social restriction)
3. HADS
4. EQ-5D
5. Death
6. Hospitalisation
7. Institutionalisation
8. Costs based on Client Service Receipt Inventory

Secondary outcomes measured at the final follow up at 12 months.

Previous secondary outcome measure(s):
The secondary outcome measures for patients at 6 months and 12 months are:
1. Hospital Anxiety and Depression Scale (HADS) (mood)
2. EQ - 5D (health state)
3. Barthel Index (activities of daily living)
4. Stroke Impact Scale (functional ability and health related quality of life)
5. Costs based on the Client Service Receipt Inventory (CSRI)
6. Death
7. Institutionalisation
8. Re−admission

The Nottingham Extended Activities of Daily Living (NEADL) at 12 months is also a patient secondary outcome measure to assess whether any intervention effect is sustained.

The secondary outcome measures for caregivers at 6 and 12 months are:
1. Compliance with the intervention (LSCTC, measured by number of training sessions, time taken, competencies signed off)
2. Caregivers Burden Scale
3. Frenchay activities index (social restriction)
4. HADS (mood)
5. EQ−5D (health state)
6. Death
7. Hospitalisation
8. Institutionalisation

Overall trial start date

18/02/2008

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 19/03/2008:
Stroke Rehabilitation Units:
A stroke rehabilitation unit will be defined according to the definition provided by the Royal College of Physicians of London for the National Sentinel Stroke Audit 2004 by the presence of 4/5 of the following criteria:
1. Consultant physician with responsibility for stroke
2. Formal links with patient and caregiver organisations
3. Multidisciplinary meetings at least weekly to plan patient care
4. Provision of information to patients about stroke
5. Continuing education programmes for staff

Patient:
1. Patient has a confirmed primary diagnosis of new stroke
2. Is medically stable
3. Is likely to return home but with residual disability
4. Have a caregiver available, defined as the main person, other than health, social or voluntary care provider, helping with activities of daily living and/or advocating on behalf of the patient
5. Written informed consent/caregiver assent and caregiver consent will be obtained prior to any trial specific procedures

Caregiver:
1. Caregiver is willing and able to provide support after discharge
2. Fulfils the trial definition of a caregiver

Previous inclusion criteria:
Stroke Rehabilitation Units:
A stroke rehabilitation unit will be defined according to the definition provided by the Royal College of Physicians of London for the National Sentinel Stroke Audit 2004 by the presence of 4/5 of the following criteria:
1. Consultant physician with responsibility for stroke
2. Formal links with patient and caregiver organisations
3. Multidisciplinary meetings at least weekly to plan patient care
4. Provision of information to patients about stroke
5. Continuing education programmes for staff

An additional criterion will be that the majority of patients on the unit will have a diagnosis of stroke.

Patients with the following characteristics are eligible for this trial:
1. Have a confirmed primary diagnosis of new stroke
2. Are medically stable (defined as sitting out of bed for at least four hours per day)
3. Are likely to return home but with residual disability (defined as a modified Rankin score of >=3)
4. Have a caregiver available, defined as the main person, other than health, social, or voluntary care provider, helping with activities of daily living and advocating on behalf of the patient, who has no notable disability (defined as a modified Rankin score of 0-2) and who is willing and able to provide support after discharge
5. Written informed patient consent/relative assent and caregiver consent will be obtained prior to any trial specific procedures

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

900 patients and caregivers

Participant exclusion criteria

Current exclusion criteria as of 19/03/2008:
1. If discharge is planned within one week of admission to the stroke rehabilitation unit (insufficient time to instigate the intervention)
2. If the patient is in need of palliative care
3. If the patient or caregiver were registered to the trial on a previous admission

Previous exclusion criteria:
1. If discharge is planned within 96 hours of admission to the stroke rehabilitation unit (insufficient time to instigate the LSCTC)
2. If the patient has a concurrent illness requiring, or likely to require, palliative care
3. If the patient or caregiver was registered to the trial on a previous admission

Recruitment start date

18/02/2008

Recruitment end date

31/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Elderly Care and Rehabilitation
Bradford
BD9 6RJ
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Faculty of Medicine and Health
Research Office
Room 7.11
Level 7
Worsley Building
University of Leeds
Claredon Way
Leeds
LS2 9NL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24054816
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24153026

Publication citations

  1. Results

    Forster A, Dickerson J, Young J, Patel A, Kalra L, Nixon J, Smithard D, Knapp M, Holloway I, Anwar S, Farrin A, , A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis., Lancet, 2013, 382, 9910, 2069-2076, doi: 10.1016/S0140-6736(13)61603-7.

  2. Results

    Forster A, Dickerson J, Young J, Patel A, Kalra L, Nixon J, Smithard D, Knapp M, Holloway I, Anwar S, Farrin A, , A cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial., Health Technol Assess, 2013, 17, 46, 1-216, doi: 10.3310/hta17460.

Additional files

Editorial Notes