Abstract
BackgroundImpairments 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/DesignThis 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.DiscussionThe 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 registrationISRCTN65792154; Date: 18 October 2012
Highlights
Impairments of memory are commonly reported by people with traumatic brain injuries (TBI)
Care costs escalate when an intervention is provided on an inpatient basis, but Salazar et al [6] demonstrated that the benefits of inpatient and home cognitive rehabilitation programmes for TBI, in terms of return to duty or employment, were similar
Doornhein and de Haan [12] reported that patients who received a memory training programme performed significantly better than those in a pseudotreatment control group on trained memory tasks, but no differences were observed on subjective ratings of everyday memory functions
Summary
This study was conceptualised in response to a commissioned call for ‘proposals concerning people needing physical or psychological rehabilitation following trauma in a military or civilian context’ from the Health Technology Assessment (HTA) Programme [38]. Our choice of primary outcome measure was a point of contention, with some of our reviewers suggesting ‘objective’ measures of memory, others recommending the use of goal attainment scaling, and yet others agreeing that the primary outcome had to be a subjective report of memory function in daily life. We anticipate that one of the biggest challenges to recruit to this study will be potential participants’ memory problems themselves. Even those interested in taking part in this trial when they receive our invitation letter may forget to respond.
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