Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): A mixed‑methods, multi‑centre feasibility randomised controlled trial
Le résumé fourni par la source
Background: Cognitive difficulties are common in people with multiple sclerosis (pwMS), yet access to neuropsychological rehabilitation is often limited or only provided to those with more severe impairments. The NEuRoMS intervention provides brief, tailored neuropsychological rehabilitation for pwMS with mild-to-moderate cognitive difficulties. Objectives: To evaluate feasibility and acceptability of the intervention and test procedures for a definitive trial. Methods: A mixed-methods, multi-centre feasibility randomised controlled trial (RCT) was conducted. Feasibility outcomes were recruitment, retention, outcome completion, randomisation, intervention delivery and fidelity. Quantitative data were collected at baseline, 3- and 6-months, supplemented by interviews with pwMS and healthcare providers. Results: Seventy-nine participants were randomised (mean age=54.5 (SD=11.5); 70% women) from three UK MS clinics. Most feasibility criteria were met: retention (>80%) and outcome-measure completion (81-89%) were high, and trial procedures were acceptable. Intervention delivery was feasible and delivered as intended, but staffing-related recruitment challenges need addressing in future trials. Preliminary signal of efficacy was observed, with 3.42-point difference (effect size=0.48) in planned primary outcome (MS psychological impact) favouring intervention, supported by qualitative evidence of sustained behaviour change. Conclusion: The NEuRoMS intervention and trial procedures were feasible and acceptable, with early indication of efficacy. Definitive RCT is underway.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.