Rehabilitation of Memory following Brain Injury (ReMemBrIn): study protocol for a randomised controlled trial

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• 作者：Roshan das Nair (20) (21)
  Nadina B Lincoln (20)
  Deborah Ftizsimmons (22)
  Nicola Brain (23)
  Alan Montgomery (24)
  Lucy Bradshaw (24)
  Avril Drummond (25)
  Catherine Sackley (26)
  Gavin Newby (27)
  Jim Thornton (24)
  Sandip Stapleton (24)
  Anthony Pink (28)
  
  20. Division of Rehabilitation and Ageing ; Queens Medical Centre ; University of Nottingham ; Nottingham ; NG7 2UH ; UK
  21. Dept of Clinical Psychology & Neuropsychology ; Nottingham University Hospitals NHS Trust ; Nottingham ; NG7 2UH ; UK
  22. Swansea Centre for Health Economics ; College of Human and Health Sciences ; Swansea University ; Singleton Campus ; Swansea ; SA2 8PP ; UK
  23. Rehabilitation Medicine ; Level 1 ; Royal Derby Hospital ; Derby Hospitals NHS Foundations Trust ; Derby ; DE22 3NE ; UK
  24. Nottingham Clinical Trials Unit ; C floor South Block ; QMC ; Nottingham ; NG7 2UH ; UK
  25. School of Nursing ; Queens Medical Centre ; University of Nottingham ; B Floor ; South Block ; Nottingham ; NG7 2UH ; UK
  26. Faculty of Medicine & Health Sciences ; University of East Anglia ; Queens Building ; Norwich Research Park ; Norwich ; NR4 7TJ ; UK
  27. Acquired Brain Injury Service ; Acorn Suite ; 1829 Building ; Countess of Chester Health Park ; Liverpool Road ; Chester ; CH2 1HJ ; UK
  28. Service User Representative ; Kragujevac ; UK
  
• 关键词：Traumatic brain injury ; Memory ; Cognitive rehabilitation ; Randomised controlled trial ; Cost ; effectiveness
• 刊名：Trials
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：16
• 期：1
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• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

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. Trial registration ISRCTN65792154; Date: 18 October 2012