title: Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN65792154; Date: 18 October 2012.
authors.affiliation: Division of Rehabilitation and Ageing, Queens Medical Centre, University of Nottingham, Nottingham NG7 2UH, UK. Roshan.nair@nottingham.ac.uk.
authors.forename: Roshan
authors.initials: R
authors.lastname: das Nair
authors.forename: Nadina B
authors.initials: NB
authors.lastname: Lincoln
authors.forename: Deborah
authors.initials: D
authors.lastname: Ftizsimmons
authors.forename: Nicola
authors.initials: N
authors.lastname: Brain
authors.forename: Alan
authors.initials: A
authors.lastname: Montgomery
authors.forename: Lucy
authors.initials: L
authors.lastname: Bradshaw
authors.forename: Avril
authors.initials: A
authors.lastname: Drummond
authors.forename: Catherine
authors.initials: C
authors.lastname: Sackley
authors.forename: Gavin
authors.initials: G
authors.lastname: Newby
authors.forename: Jim
authors.initials: J
authors.lastname: Thornton
authors.forename: Sandip
authors.initials: S
authors.lastname: Stapleton
authors.forename: Anthony
authors.initials: A
authors.lastname: Pink
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D000368:Aged; D001930:Brain Injuries / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000534:rehabilitation*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008568:Memory; D008569:Memory Disorders / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000534:rehabilitation*; D008875:Middle Aged; D011615:Psychotherapy, Group / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult