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.
Objectives
To assess the clinical and cost-effectiveness of a group memory rehabilitation programme for people with TBI.
Design
Multi-centre, 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, with TBI more than 3 months prior to recruitment, reported memory problems, who were able to travel to a site to attend group sessions, communicate in English, and gave informed consent.
Randomisation and blinding
Clusters of 4 to 6 participants were randomised to intervention or control 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; outcome assessors were blinded.
Interventions
Ten 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 control arm received usual care only.
Outcomes
Outcomes were assessed at 6 and 12 months after randomisation. Primary: Patient-completed Everyday Memory Questionnaire (EMQ-p) at 6-month follow-up. Secondary: Rivermead Behavioural Memory Test-3, General Health Questionnaire-30, European Brain Injury Questionnaire, Everyday Memory Questionnaire-relative version, individual goal attainment. Costs (based on a UK NHS and PSS perspective) were collected using a service use questionnaire, with the EQ-5D 5L used to derive Quality Adjusted Life Years. A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with 3.5% discount applied.
Results
We randomised 328 participants (intervention: n=171; control: n=157), with 129 in the intervention arm and 122 in the control arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6-month follow-up (adjusted difference in means -2.1, 95% CI -6.7 to 2.5, p=0.37). For secondary outcomes, differences favouring the intervention arm were observed at 6-month follow-up for RBMT and goal attainment, but remained only for goal attainment at 12-month follow-up. There were no differences between arms in mood or quality of life. 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 reported.
Limitations
As a pragmatic trial, we had broad inclusion criteria, therefore there was considerable heterogeneity within the sample. The study was not powered to perform further sub-group 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 work
Future studies should examine the inclusion and selection of participants who may benefit most from memory rehabilitation.
Registration
ISRCTN65792154
Funding
National Institute for Health Research, Health Technology Assessmen
