Background: People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital.
Objective: To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI.
Design: Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken.
Setting: Community settings in nine sites in England.
Participants: Participants were aged 18-69 years, had undergone a TBI > 3 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent.
Randomisation and blinding: Clusters of four to six participants were randomised to the memory rehabilitation arm or the usual-care arm on a 1 : 1 ratio. Randomisation was based on a computer-generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site. Participants and therapists were aware of the treatment allocation whereas outcome assessors were blinded.
Interventions: In the memory rehabilitation arm 10 weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The usual-care arm received usual care only.
Main outcome measures: Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire - patient version (EMQ-p) at 6 months' follow-up. Secondary outcomes: Rivermead Behavioural Memory Test - third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire - relative version and individual goal attainment. Costs (based on a UK NHS and Personal Social Services perspective) were collected using a service use questionnaire, with the EuroQol-5 Dimensions, five-level version, used to derive quality-adjusted life-years (QALYs). A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with a 3.5% discount applied.
Results: We randomised 328 participants (memory rehabilitation, n = 171; usual care, n = 157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5; p = 0.37). For secondary outcomes, differences favouring the memory rehabilitation arm were observed at 6 months' follow-up for the RBMT-3 and goal attainment, but remained only for goal attainment at 12 months' follow-up. There were no differences between arms in mood or quality of life. The qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12 months found memory rehabilitation to be £26.89 cheaper than usual care but less effective, with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths were reported.
Limitations: As a pragmatic trial, we had broad inclusion criteria and, therefore, there was considerable heterogeneity within the sample. The study was not powered to perform further subgroup analyses. Participants and therapists could not be blinded to treatment allocation.
Conclusions: The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community. Future studies should examine the selection of participants who may benefit most from memory rehabilitation.
Trial registration: Current Controlled Trials ISRCTN65792154.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 16. See the NIHR Journals Library website for further project information.
Keywords: BRAIN INJURIES; BRAIN INJURIES, TRAUMATIC; COGNITIVE REHABILITATION; COST–BENEFIT ANALYSIS; MEMORY; MEMORY PROBLEMS; MEMORY REHABILITATION; TRAUMATIC BRAIN INJURY.
People with brain injuries often report memory problems. These difficulties can continue long after the injury, causing complications in daily life. Many people do not receive specific help for these memory problems after leaving hospital. Our study explored whether receiving ‘memory rehabilitation’ (a group treatment to help people deal with memory difficulties) was better than the treatment that people usually receive to help reduce the frequency of forgetting in daily life. We recruited 328 people who had memory problems following brain injury. About half were allocated at random to receive memory rehabilitation and half did not have any extra memory treatments, but everyone continued to receive their usual care. Those who had memory rehabilitation were offered 10 group sessions at which strategies were taught to help them cope with memory problems. We asked all participants to complete memory tests and questionnaires at the start of the study and again 6 and 12 months afterwards to find out whether the memory rehabilitation had any effect. Some participants were also interviewed about the study. At the 6- and 12-month assessments, there were no differences between those who received memory rehabilitation and those who did not in terms of how often participants reported memory problems in their daily lives or how well they performed on memory tests. We also did not find any differences in participants’ mood or quality of life. However, individual goals set by the participants at the start of the study were a little better met by those who received memory rehabilitation than by those who did not. The memory rehabilitation did not represent value for money. In interviews, participants reported positive experiences of taking part in the study and of attending the group sessions. This group memory rehabilitation programme is unlikely to help people with memory problems following a brain injury more than the usual treatment that people receive. Some people may benefit more from memory rehabilitation than others, but this needs further investigation.