Rehabilitation of memory following traumatic brain injury

ISRCTN ISRCTN65792154
DOI https://doi.org/10.1186/ISRCTN65792154
Secondary identifying numbers 12944
Submission date
17/10/2012
Registration date
18/10/2012
Last edited
30/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Florence Day
Scientific

Nottingham University
Clinical Trials Unit
School of Medicine
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Email remembrin@nottingham.ac.uk

Study information

Study designRandomised interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleRehabilitation of memory following traumatic brain injury: – a Phase III randomised controlled trial
Study acronymReMemBrin
Study objectivesAround 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(s)East Midlands – Nottingham Research Ethics Committee, 21/09/2012, ref: 12/EM/0324
Health condition(s) or problem(s) studiedBrain injuries and emergencies
InterventionMemory 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 typeOther
Primary outcome measureFrequency of memory failures in daily life, assessed using the Everyday Memory Questionnaire participant report (EMQ-p) at 6 months
Secondary outcome measuresAdded 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 study start date01/03/2013
Completion date30/04/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsUK Sample Size: 312
Total final enrolment328
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/03/2013
Date of final enrolment22/12/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Nottingham University Hospitals NHS Trust
NG5 1PB
United Kingdom
Birmingham Community Healthcare NHS Trust
B7 4BN
United Kingdom
Chester and Wirral Partnership NHS Foundation Trust
CH2 1BQ
United Kingdom
Central Surrey Health
KT19 0DZ
United Kingdom
The Walton Centre NHS Foundation Trust
L9 7LJ
United Kingdom
Sheffield Health and Social Care NHS Foundation Trust
S10 3TH
United Kingdom
St George’s Healthcare NHS Trust
SW17 0QT
United Kingdom
North Bristol NHS Trust
BS10 5NB
United Kingdom
South Tees Hospitals NHS Foundation Trust
DL6 1JG
United Kingdom

Sponsor information

Nottingham University Hospitals NHS Trust (UK)
Hospital/treatment centre

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom

Website http://www.nuh.nhs.uk/
ROR logo "ROR" https://ror.org/05y3qh794

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date30/04/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe 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).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 06/01/2015 Yes No
Results article results 01/04/2019 30/04/2019 Yes No

Editorial Notes

30/04/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
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.