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Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial

das Nair, Roshan; Lincoln, Nadina; Ftizsimmons, Deborah; Brain, Nicola; Montgomery, Alan; Bradshaw, Lucy; Drummond, Avril E.R.; Sackley, Catherine Mary; Newby, Gavin; Thornton, Jim; Stapleton, Sandip; Pink, Anthony

Authors

ROSHAN NAIR Roshan.dasnair@nottingham.ac.uk
Professor of Clinical Psychology and Neuropsychology

Nadina Lincoln

Deborah Ftizsimmons

Nicola Brain

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director, nottingham Clinical Trials Unit

AVRIL DRUMMOND avril.drummond@nottingham.ac.uk
Professor of Healthcare Research

Catherine Mary Sackley

Gavin Newby

JIM THORNTON jim.thornton@nottingham.ac.uk
Professor of Obstetrics and Gynaecology

Sandip Stapleton

Anthony Pink



Abstract

Background
Impairments of memory are commonly reported by people with traumatic brain injuries (TBI). Such deficits are persistent, debilitating, and can severely impact quality of life. Currently, many do not routinely receive follow-up appointments for residual memory problems following discharge.

Methods/Design
This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based memory rehabilitation programme. Three hundred and twelve people with a traumatic brain injury will be randomised from four centres. Participants will be eligible if they had a traumatic brain injury more than 3 months prior to recruitment, have memory problems, are 18 to 69 years of age, are able to travel to one of our centres and attend group sessions, and are able to give informed consent. Participants will be randomised in clusters of 4 to 6 to the group rehabilitation intervention or to usual care. Intervention groups will receive 10 weekly sessions of a manualised memory rehabilitation programme, which has been developed in previous pilot studies. The intervention will include restitution strategies to retrain impaired memory functions and compensation strategies to enable participants to cope with their memory problems. All participants will receive a follow-up postal questionnaire and an assessment by a research assistant at 6 and 12 months post-randomisation. The primary outcome is the Everyday Memory Questionnaire at 6 months. Secondary outcomes include the Rivermead Behavioural Memory Test-3, General Health Questionnaire-30, health related quality of life, cost-effectiveness analysis determined by the EQ-5D and a service use questionnaire, individual goal attainment, European Brain Injury Questionnaire (patient and relative versions), and the Everyday Memory Questionnaire-relative version. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the Everyday Memory Questionnaire at 6 months will be used to estimate the effect of the group memory rehabilitation programme.

Discussion
The study will hopefully provide robust evidence regarding the clinical and cost-effectiveness of a group-based memory rehabilitation intervention for civilians and military personnel following TBI. We discuss our decision-making regarding choice of outcome measures and control group, and the unique challenges to recruiting people with memory problems to trials.

Journal Article Type Article
Publication Date Jan 6, 2015
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 16
Issue 6
APA6 Citation das Nair, R., Lincoln, N., Ftizsimmons, D., Brain, N., Montgomery, A., Bradshaw, L., …Pink, A. (2015). Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial. Trials, 16(6), https://doi.org/10.1186/1745-6215-16-6
DOI https://doi.org/10.1186/1745-6215-16-6
Keywords Traumatic brain injury, Memory, Cognitive rehabilitation, Randomised controlled trial, Cost-effectiveness
Publisher URL http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-16-6
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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