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 measure
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 (if study stopped)
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
Total final enrolment
328
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
United Kingdom
Trial participating centre
Birmingham Community Healthcare NHS Trust
B7 4BN
United Kingdom
Trial participating centre
Chester and Wirral Partnership NHS Foundation Trust
CH2 1BQ
United Kingdom
Trial participating centre
Central Surrey Health
KT19 0DZ
United Kingdom
Trial participating centre
The Walton Centre NHS Foundation Trust
L9 7LJ
United Kingdom
Trial participating centre
Sheffield Health and Social Care NHS Foundation Trust
S10 3TH
United Kingdom
Trial participating centre
St George’s Healthcare NHS Trust
SW17 0QT
United Kingdom
Trial participating centre
North Bristol NHS Trust
BS10 5NB
United Kingdom
Trial participating centre
South Tees Hospitals NHS Foundation Trust
DL6 1JG
United Kingdom
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
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
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
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25559090
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31032782 (added 30/04/2019)