Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/10/2012
Date assigned
18/10/2012
Last edited
22/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Currently, traumatic brain injury patients with memory problems do not routinely receive rehabilitation after the early intensive treatment, even though their abilities and needs may change once they have left the hospital. The aim of this study is to investigate how effective a group-based memory rehabilitation programme is for military personnel and civilians who have sustained a traumatic brain injury.

Who can participate?
Men and women, civilians and military personnel, aged 18 to 69, more than 3 months since a traumatic brain injury.

What does the study involve?
Participants are randomly allocated to receive either 10 group memory rehabilitation sessions or usual care, and are followed up for 12 months.

What are the possible benefits and risks of participating?
The exact benefits of the rehabilitation programme are not known, but it is hoped that participants will benefit from it. The information obtained from this study may help to improve the treatment of future patients with memory problems after a head injury. There are no particular risks involved in taking part in this study. However, participants may be made aware of memory problems that they did not know they had. The Assistant Psychologist is trained to be able to help with this.

Where is the study run from?
1. Nottingham University Hospitals NHS Trust (UK)
2. Birmingham Community Healthcare NHS Trust (UK)
3. Chester and Wirral Partnership NHS Foundation Trust (UK)
4. Central Surrey Health (UK)
5. The Walton Centre NHS Foundation Trust (UK)
6. Sheffield Health and Social Care NHS Foundation Trust (UK)
7. St George’s Healthcare NHS Trust (UK)
8. North Bristol NHS Trust (UK)
9. South Tees Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
March 2013 to April 2017

Who is funding the study?
National Institute for Health Research Health Technology Assessment Programme (UK)

Who is the main contact?
Roshan das Nair
Roshan.dasnair@nottingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Florence Day

ORCID ID

Contact details

Nottingham University
Clinical Trials Unit
School of Medicine
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
-
remembrin@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12944

Study information

Scientific title

Rehabilitation of memory following traumatic brain injury: – a Phase III randomised controlled trial

Acronym

ReMemBrin

Study hypothesis

Around 6% of patients are admitted to Accident and Emergency departments in the UK as a result of a head injury. A study in the United States also found that 25 per cent of soldiers will experience a head injury during their army career. Following this type of injury a lot of these patients will find that they have long lasting problems with their memory affecting their life in a negative way. For example, some patients may not be able to return to work and notice that their memory problems have an effect on their social life and relationships. At the moment patients who have had a head injury are not always given any further therapy after they leave the hospital to help them deal with their memory problems. However, sometimes they find that their memory problems change or as their lifestyle changes.

The aim of this study is to compare a memory rehabilitation programme with current clinical care. The study will assess the usefulness of memory rehabilitation in reducing problems with memory and how much it would cost to the NHS.

Ethics approval

East Midlands – Nottingham Research Ethics Committee, 21/09/2012, ref: 12/EM/0324

Study design

Randomised interventional trial

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 to request a patient information sheet

Condition

Brain injuries and emergencies

Intervention

Memory rehabilitation
The intervention will be offered in a group setting. Each group will be led by an Assistant Psychologist (AP) and consist of 4-6 participants. The APs at the different centres will be trained. Participants will receive 10 group memory rehabilitation sessions (1.5 hours long, once a week for 10 weeks), following a treatment manual which was developed and tested in the pilot study. Follow up length: 12 months.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Frequency of memory failures in daily life, assessed using the Everyday Memory Questionnaire participant report (EMQ-p) at 6 months

Secondary outcome measures

Added 22/06/2017:
Assessed at 6 and 12 months after randomisation:
1. Individual goal attainment, evaluated on a 4-point Likert scale
2. Memory, assessed using the Rivermead Behavioural Memory Test, RBMT-3
3. Cognitive, emotional, and social wellbeing, measured using the European Brain Injury Questionnaire (EBIQ) patient and relative versions
4. Mood, assessed using the General Health Questionnaire (GHQ 30)
5. Health-related quality of life, assessed using the EQ5D
6. Frequency of memory failures in daily life, assessed using the Everyday Memory Questionnaire participant version (EMQ-p) at 12 months
7. Cost-effectiveness from an NHS perspective, assessed using the service use questionnaire. This cost data is compared to the Quality Adjusted Life Year scores (QALYs) calculated from the responses from the EQ-5D. This will be used to calculate an Incremental Cost-Effectiveness Ratio.
8. Frequency of memory failures in daily life, assessed using the Everyday Memory Questionnaire friend/relative report (EMQ-r)

Overall trial start date

01/03/2013

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Were admitted to hospital with a TBI more than 3 months prior to recruitment
2. Report having memory problems as assessed at baseline
3. Are 18 to 69 years of age
4. Are able to travel to one of the study centres and attend group sessions
5. Give informed consent.
6. Men and women

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 312

Participant exclusion criteria

1. Unable or unsuitable to engage in group treatment if allocated
2. Are involved in other psychological intervention trials
3. Impairment of language, as assessed on the SST (cut-off score <17)

Recruitment start date

01/03/2013

Recruitment end date

22/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
NG5 1PB

Trial participating centre

Birmingham Community Healthcare NHS Trust
B7 4BN

Trial participating centre

Chester and Wirral Partnership NHS Foundation Trust
CH2 1BQ

Trial participating centre

Central Surrey Health
KT19 0DZ

Trial participating centre

The Walton Centre NHS Foundation Trust
L9 7LJ

Trial participating centre

Sheffield Health and Social Care NHS Foundation Trust
S10 3TH

Trial participating centre

St George’s Healthcare NHS Trust
SW17 0QT

Trial participating centre

North Bristol NHS Trust
BS10 5NB

Trial participating centre

South Tees Hospitals NHS Foundation Trust
DL6 1JG

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nuh.nhs.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

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Roshan das Nair (roshan.dasnair@nottingham.ac.uk).

Intention to publish date

30/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25559090

Publication citations

Additional files

Editorial Notes

22/06/2017: The following changes were made to the trial record: 1. The overall trial end date was changed from 01/04/2015 to 30/04/2017. 2. The recruitment end date was changed from 01/04/2015 to 22/12/2015.