Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial
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...
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| Format: | Article |
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BioMed Central
2015
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| Online Access: | https://eprints.nottingham.ac.uk/33834/ |
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| author | das Nair, Roshan Lincoln, Nadina Ftizsimmons, Deborah Brain, Nicola Montgomery, Alan Bradshaw, Lucy Drummond, Avril E.R. Sackley, Catherine Mary Newby, Gavin Thornton, Jim Stapleton, Sandip Pink, Anthony |
| author_facet | das Nair, Roshan Lincoln, Nadina Ftizsimmons, Deborah Brain, Nicola Montgomery, Alan Bradshaw, Lucy Drummond, Avril E.R. Sackley, Catherine Mary Newby, Gavin Thornton, Jim Stapleton, Sandip Pink, Anthony |
| author_sort | das Nair, Roshan |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T19:20:35Z |
| format | Article |
| id | nottingham-33834 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:20:35Z |
| publishDate | 2015 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-338342020-05-04T17:01:23Z https://eprints.nottingham.ac.uk/33834/ Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial das Nair, Roshan Lincoln, Nadina Ftizsimmons, Deborah Brain, Nicola Montgomery, Alan Bradshaw, Lucy Drummond, Avril E.R. Sackley, Catherine Mary Newby, Gavin Thornton, Jim Stapleton, Sandip Pink, Anthony 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. BioMed Central 2015-01-06 Article PeerReviewed das Nair, Roshan, Lincoln, Nadina, Ftizsimmons, Deborah, Brain, Nicola, Montgomery, Alan, Bradshaw, Lucy, Drummond, Avril E.R., Sackley, Catherine Mary, Newby, Gavin, Thornton, Jim, Stapleton, Sandip and Pink, Anthony (2015) Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial. Trials, 16 (6). pp. 1-9. ISSN 1745-6215 Traumatic brain injury Memory Cognitive rehabilitation Randomised controlled trial Cost-effectiveness http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-16-6 doi:10.1186/1745-6215-16-6 doi:10.1186/1745-6215-16-6 |
| spellingShingle | Traumatic brain injury Memory Cognitive rehabilitation Randomised controlled trial Cost-effectiveness das Nair, Roshan Lincoln, Nadina Ftizsimmons, Deborah Brain, Nicola Montgomery, Alan Bradshaw, Lucy Drummond, Avril E.R. Sackley, Catherine Mary Newby, Gavin Thornton, Jim Stapleton, Sandip Pink, Anthony Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial |
| title | Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial |
| title_full | Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial |
| title_fullStr | Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial |
| title_full_unstemmed | Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial |
| title_short | Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial |
| title_sort | rehabilitation of memory following brain injury (remembrin): study protocol for a randomised controlled trial |
| topic | Traumatic brain injury Memory Cognitive rehabilitation Randomised controlled trial Cost-effectiveness |
| url | https://eprints.nottingham.ac.uk/33834/ https://eprints.nottingham.ac.uk/33834/ https://eprints.nottingham.ac.uk/33834/ |