Abstract
BackgroundPeople with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual’s memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope with these problems, in order to reduce the impact on everyday life. The effectiveness of cognitive rehabilitation for people with multiple sclerosis has not been established.MethodsThis is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems.All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological subscale at 12 months will be used to estimate the effect of the group cognitive rehabilitation programme.DiscussionThe study will provide evidence regarding the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems in people with multiple sclerosis.Trial registrationISRCTN09697576. Registered 14 August 2014.
Highlights
People with multiple sclerosis have problems with memory and attention
Our choice of primary outcome measure was based on the need to consider the impact of cognitive problems on everyday life
We have retained both objective measures of attention and memory and self-reported measures, but these are secondary outcomes
Summary
Trial objectives The primary objective is to determine whether attending a group cognitive rehabilitation programme (the intervention), in addition to usual care, is associated with reduced psychological impact of MS on quality of life, as measured on the MS Impact Scale (MSIS) Psychological Subscale (MSIS-Psy) [18] when compared to usual care alone (control). Cost-effectiveness, with costs measured by the Use of Health and Social Services Questionnaire compared with the primary and secondary outcomes, including a cost per quality-adjusted life year analysis using the EQ-5D-5L [26]. Insights from this qualitative analysis will serve to inform developments of the intervention programme in the future and to generate user-oriented proposals about areas for further investigations For those in the control group the interviews will provide confirmation of the nature of usual care received. Members of this committee will include rehabilitation professionals and an experienced study statistician It will safeguard the interests of trial participants, with particular reference to safety and the efficacy of the intervention, monitor the overall progress and conduct of the trial and assist and advise the investigators so as to protect the validity and credibility of the trial. All protocol deviations will be recorded on the electronic case report form by local investigator staff
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