In Ireland 9,000 people live with multiple sclerosis (MS). Cognitive difficulties affect 50-60% of people, with severity ranging. Difficutlies are likely to have a significant impact on the lives of many people with MS, such as increased likilhood of unemployment. Despite the high prevalence little has been done to address these difficulties and importantly the impact a person’s everyday life. Will will test the feasibility of a MS-specific programme- the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS). The COB-MS aims to improve patient care and has potential to have a strong positive imapct on clinical care.
We will undertake a cluster randomised control pilot trial with a SWAT. The main aim is to test the integrity of the protocol for a full-scale RCT. Specifically we will focus on recruitment methods, acceptability of the intervention and outcome measures, blinding, and retention of participants. The SWAT will focus on participant compliance with intervention requirements. Sixteen occupational therapists will run the COB-MS with 157 people with MS. Participants will be allocated to the COB-MS arm or to a wait-list control. The COB-MS takes a three-pronged approach to cognitive rehabilitation; using education, remediation and adaption to help people manage their cognitive challenges and has a mixture of group and individual sessions.
The SWAT will explore whether prompting improves compliance with homework activities. Participants will be randomly allocated to either receive twice-weekly prompts by text or else no prompting. Both qualitative and quantitative outcomes will be used – Goal Attainment Scaling will be the primary outcome measure. Secondary outcome measures will be in the areas of cognition, daily functioning, mood, quality of life and self-efficacy. Interviews will assess acceptability of the intervention. Data analysis will form part of protocol testing and a detailed analysis plan will be prepared in advance of analysis. Criteria for progression to full trial have been set.
This project has the potential to directly influence clinical practice and benefit the lives of people with MS, by enabling them to manage their disease symptoms in a positive way that allows them to continue to live well with MS.
