Schedule of enrolment, interventions and data collection following the SPIRIT guidelines
Study period | ||||
Enrolment | Postallocation | |||
Time point | Prestudy | Before staff training (T0) | After staff training (T1) | After the implementation phase (T3) |
Enrolment: | ||||
Eligibility screen | X | |||
Informed consent | X | |||
Intervention: | ||||
CogStim24 |
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Assessments: | ||||
Demographics and clinical data | X | |||
Global cognition (MMSE and ADAS-Cog) | X | X | X | |
Quality of Life (QoL-AD) | X | X | X | |
BPSD (NPI-NH) | X | X | X | |
Depression (GDS and CSDD) | X | X | X | |
Work-related Quality of life/ Stress experience (RCB-related Distress Index) | X | X | X |
ADAS-Cog, Alzheimer’s Disease Assessment Cognitive Scale; BPSD, behavioural and psychiatric symptoms in dementia; CSDD, Cornell Scale for Depression in Dementia; GDS, Geriatric Depression Scale; RCB-Related Distress Index, Residents' challenging behaviour Related Distress Index; MMSE, Mini-Mental State Examination; NPI-NH, Neuropsychiatric Inventory Nursing Home Version; QoL-AD, Quality of Life in Alzheimer’s Disease; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.