Condition category
Circulatory System
Date applied
30/01/2009
Date assigned
09/02/2009
Last edited
17/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke is a serious, life-threatening medical condition that occurs when the blood supply to part of the brain is cut off. Stroke can have a devastating effect on people's lives, with half of survivors being dependent on others six months later, one third feeling socially isolated, and half not getting out of their houses as much as they would like. The number of people living in the community after having a stroke is set to rise over the forthcoming decades, and the cost of stroke to the NHS is estimated to be over £2.5 billion per year. It is important therefore that new interventions are demonstrated to be good value for money before they are implemented. Research has shown that people living at home with stroke have felt neglected, not been given the correct information and received patchy levels of rehabilitation. Being able to get out of the house is an important rehabilitation target after stroke as it improves psychological and functional outcomes. A new outdoor mobility rehabilitation intervention has been developed and tested in one UK city. The study found that people who had received the new intervention, which involved the patient practicing outside with a therapist, were twice as likely to go out afterwards as those who had received the routine rehabilitation programme. The routine programme was verbal advice and written information. However, the study was undertaken in only one city and used only one therapist to provide the new programme. We now wish to find out if this new type of rehabilitation can have a similar positive affect on the quality of life for people in other areas, with other therapists, and whether it is a cost effective intervention.

Who can participate?
Patients aged 18 or over who had a stroke at least six weeks ago.

What does the study involve?
Participants are randomly allocated into one of two groups: the intervention group or the control group. Those who are in the intervention group are assessed by a therapist and mobility goals are set together. Over a series of about six treatment sessions the therapist works with the participant to realize the goals. This could be getting on and off a bus or walking to a friend's house. Those in the control group receive the routine intervention of verbal and written advice. The intervention is considered a success if we are able to show that intervention participants have a better quality of life than the control participants six months after recruitment. Quality of life, mobility, activities of daily living, mood, home care use, hospital admissions and attendance at the GP are assessed with questionnaires. To collect this information mobility diaries are sent monthly and questionnaires six and twelve months after recruitment. In addition an independent assessor visits the participant at home, collects any outstanding assessments and carries out a mobility assessment. The results from the assessments are used to compare the outcomes for both groups.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Queens Medical Centre (UK)

When is the study starting and how long is it expected to run for?
August 2009 to July 2012

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Pip Logan
pip.logan@nottingham.ac.uk

Trial website

http://www.gettingoutofthehousestudy.co.uk/

Contact information

Type

Scientific

Primary contact

Dr Pip Logan

ORCID ID

Contact details

B98
Community Health Sciences
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
-
pip.logan@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/14/51

Study information

Scientific title

A multicentre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people who have had a stroke

Acronym

TOMAS (Trial of Outdoor Mobility After Stroke)

Study hypothesis

What is the clinical effectiveness and cost effectiveness of treating outdoor mobility limitations after stroke with a novel targeted rehabilitation therapy intervention?

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081451
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/52371/PRO-08-14-51.pdf

Ethics approval

Nottingham Research Ethics Committee (REC) 1, 15/06/2009, ref: 09/H0403/55

Study design

Multicentre parallel-group individually randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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

Intervention

A novel rehabilitation technique (intervention) group will be compared to a usual care (control) group:

Intervention group:
Specifically designed outdoor mobility training and practice with a skilled health professional. Intervention group participants will receive up to 7 rehabilitation outdoor mobility sessions of about an hour each over 4 months. The main component of the intervention is that therapists go repeatedly with patients to try outdoor mobility, including buses, taxis, walking, voluntary drivers and mobility scooters until they feel confident to go alone or with a companion.

Control group:
Standard verbal and written information about outdoor mobility from a skilled health professional. Control Group participants will receive what is considered clinically to be routine intervention for outdoor mobility limitations. That is, verbal advice and provision of leaflets provided over one 1-hour session.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Social Function domain of the health related quality of life measure SF-36v2™ Health Survey at 6 months.

Secondary outcome measures

The following will be assessed at 6 and 12 months:
1. Functional ability, measured by the Nottingham Extended Activities of Daily Living Scale
2. Mobility using the Rivermead Mobility Index
3. Modified 15/09/09: The number of journeys (travel diaries) - was previously: The number and duration of journeys from the travel diaries
4. Satisfaction with outdoor mobility, assessed using one yes/no question: "Do you get out of the house as much as you would like?"
5. Mood, using the General Health Questionnaire 12
6. Carer psychological distress, measured using the General Health Questionnaire 12pt
7. EuroQol EQ-5D
8. Resource use of health and social care
9. Provision of equipment
10. Participant mortality will be collected from medical records

Overall trial start date

01/08/2009

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Amended as of 12/03/2010:
Point 2 below has been amended to read as follows:
2. At least six weeks since stroke

Amended as of 15/09/2009:
1. Age 18 years or over
2. At least six weeks but no longer than five years since stroke
3. Wishing to get out of the house more often
4. The participant must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal care.

Amended as of 13/07/2009:
1. Aged 18 years or over, either sex
2. At least six weeks but no longer than five years since stroke
3. Wishing to get out of the house more often
4. Able to comply with the requirements of the protocol and therapy programme
5. The participant must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal care

Initial information at time of registration:
1. Both males and females, aged 18 years or over
2. At least six weeks since stroke
3. Wishing to get out of the house more often
4. Able to comply with the requirements of the protocol and therapy programme
5. The participant or legal representative must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal care

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

676

Participant exclusion criteria

Amended as of 15/09/2009:
1. Not able to comply with the requirements of the protocol and therapy programme, in the opinion of the assessor
2. Still in post-stroke intermediate care or active rehabilitation
3. Previous enrolment in this study

Amended as of 13/07/2009:
1. Significant cognitive impairment which will impede ability to complete the assessments
2. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. terminal illness
3. Still in post-stroke intermediate care or active rehabilitation
4. Previous enrolment in this study

Initial information at time of registration:
1. Significant cognitive impairment which will impede ability to complete the assessments
2. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. terminal illness
3. Previous enrolment in this study

Recruitment start date

01/08/2009

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22721452
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24806825

Publication citations

  1. Protocol

    Logan PA, Leighton MP, Walker MF, Armstrong S, Gladman JR, Sach TH, Smith S, Newell O, Avery T, Williams H, Scott J, O'Neil K, McCluskey A, Leach S, Barer D, Ritchie C, Turton A, Bisiker J, Smithard D, Baird T, Guyler P, Jackson T, Watmough I, Webster M, Ivey J, A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: study protocol for a randomised controlled trial., Trials, 2012, 13, 86, doi: 10.1186/1745-6215-13-86.

  2. Results

    Logan PA, Armstrong S, Avery TJ, Barer D, Barton GR, Darby J, Gladman JR, Horne J, Leach S, Lincoln NB, Mehta S, Newell O, O'Neil K, Sach TH, Walker MF, Williams HC, Woodhouse LJ, Leighton MP, Rehabilitation aimed at improving outdoor mobility for people after stroke: a multicentre randomised controlled study (the Getting out of the House Study), Health Technol Assess, 2014, 18, 29, 1-113, doi: 10.3310/hta18290.

Additional files

Editorial Notes

17/05/2016: Plain English summary added. 13/07/2009: the following changes were made to the trial record: 1. Initial anticipated start date: 01/03/2009 2. initial anticipated end date: 28/02/2012