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A Cognitive Occupation-Based programme for people with Multiple Sclerosis: definitive trial (COB-MS)

Cognitive difficulties can have significant impacts on daily function and quality of life of people with multiple sclerosis (MS). Although a common symptom of MS, it is often not treated in clinical care, despite the potential for devastating impacts. When treated, occupational therapists are the healthcare professionals most commonly responsible for the assessment and management of cognitive symptoms in MS. Despite this, no cognitive rehabilitation intervention has been developed that is measured by and taught through an occupational participation perspective. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed to address the clinical treatment deficit. The COB-MS is a personalised, patient-centred, holistic, occupational therapy, cognitive rehabilitation intervention. It is aimed at improving daily life functioning for people with MS who are experiencing cognitive difficulties.
The COB-MS has undergone extensive feasibility testing and has been found to be both feasible and acceptable by clinicians and participants with MS. The aim of this research is to estimate the clinical and cost-effectiveness of the COB-MS intervention relative to a treatment-as-usual control group. This study is a single-blind, three-arm, pragmatic randomised trial with two SWATs. We will establish the effectiveness of both online and in-person delivery of the COB-MS, relative to control condition. This will be achieved through five separate work packages (WP), and follow FAIR data management principles:
WP1: Internal Pilot Phase.
WP2: Evaluation of the clinical effectiveness of the COB-MS through quantitative and qualitative outcomes.
WP3: COB-MS cost-effectiveness analysis.
WP4: Process Evaluation.
WP4: Two SWATs focused on core outcome set development and retention to be carried out in conjunction with the main trial.
This definitive trial, and associated SWATs, are led by the needs of the MS community at national and international levels and have a strong PPI-focus throughout. This research is innovative and very timely and links with priority research areas in multiple sclerosis rehabilitation, occupational therapy, and trial methodology, ensuring the international relevance of the research to the MS rehabilitation research community, knowledge-users, and those living with MS. The COB-MS team consists of experts in multiple disciplines, trial methodology, health economics, statistics, health service research, and related disciplines.