Endpoints
anxiety/depression
The primary endpoint was QoL SF-36 physical component summary (PCS) and mental component summary (MCS) score changes at M12 and M24 compared to baseline in each group. Secondary endpoints included i) QoL changes in SF-36 subscales, anxiety/depression, and burden at M12 and M24 compared to baseline; ii) longitudinal assessments of caregiver QoL, anxiety/depression, and burden over the 2 years. Exploratory analyses were performed to assess changes from baseline in caregiver involvement in activities of daily living, and to assess professional and financial support requested by caregivers, at M12 and at M24.