A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT

Abstract

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.

Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS)

“…23–25 Therefore, the sample included those with relatively severe cognitive problems in daily life, and these people may benefit less from the intervention. 26…”

“…These findings are consistent with previous cognitive rehabilitation research in people with multiple sclerosis, 27,28 in that they show benefits of cognitive rehabilitation that focusses on teaching strategies to cope with cognitive impairments in daily life on measures of memory problems in daily life. However, comparison with the ReMemBrIn trial, 26 which evaluated the same intervention in people with traumatic brain injury, suggested that those with multiple sclerosis responded better than those with traumatic brain injury. One possible reason is that usual care for people with traumatic brain injury in the United Kingdom often includes cognitive rehabilitation, whereas it does not for people with multiple sclerosis.…”

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial

“…Sensitivity analyses for the primary outcome found similar results to the primary analysis. 20 There was no evidence of difference in the effect of the memory rehabilitation sessions across subgroups based on baseline memory impairment (Rivermead Behavioural Memory Test General Memory Index); the p -value for interaction effect was 0.12. However, the difference in mean Everyday Memory Questionnaire – patient version score in the subgroup of those with borderline/moderate memory impairment favoured the memory rehabilitation arm (adjusted difference in means: –7.1 (95% CI: –13.9 to −0.3, n = 102).…”

“…Another strength was that all the trial therapists were trained to deliver the intervention with competence and confidence, and there was little variability in terms of their competence. 20 Regular supervision and monitoring (including video recording of sessions) enabled fidelity to the treatment delivery.…”

“…Therapist skill at delivering the intervention was also assessed independently and reported elsewhere. 20,21…”