Case management in a web-based cognitive and motor treatment for patients with mild cognitive impairment: A study protocol of a multicentric, randomized, two parallel arms controlled clinical trial

Objective: The growing attention towards the psychosocial characteristics of mild cognitive impairment (MCI), a possible prodromal stage of dementia, contributed to the spread of patient-centered approaches to the care of age-related cognitive decline. Within these new care models, including Case-Management approaches, technology-based treatments showed to improve quality of life and psychosocial functioning of people with MCI. However, studies testing technologies to treat functional well-being of MCI patients are still few. Moreover, whether Case Manager supervised or unsupervised technological interventions lead to comparable results is so far unexplored. This study protocol aims to test the superiority of a 1-year physical and cognitive training treatment supervised by a Case Manager in improving the quality of life, functional decline, treatment adherence, cognitive impairment of MCI patients and the mental well-being of informal caregivers compared to the same yet unsupervised treatment. Methods: In a multicentric, randomized, two parallel arms controlled clinical trial MCI patients ≥65 year-old will be randomized to receive a technology-based treatment either supervised or unsupervised by a Case Manager. Regardless of the study group, patients will perform cognitive and motor exercises with the monitoring of a specialist only during the first 6 weeks of intervention. Three and two assessment points will be considered during the intervention and follow-up period, respectively. The quality of life will be measured as primary outcome at 6 months after baseline. Conclusions: The results of this study will provide an evidence base to use Case Management as an adjuvant approach for technology-based treatments of psychosocial characteristics of MCI.