Table 2.
Outcome measures
| Outcome | Measure | Purpose | Respondent | Time of assessment |
|---|---|---|---|---|
| Demographic characteristics | For example, age, education, sex, ethnicity, relation to caregiver | Descriptive, covariate, moderator | Patient and caregiver | T0 |
| Clinical characteristics | For example, diagnosis, AD biomarkers, disease duration | Descriptive, moderator | Patient and caregiver | T0* |
| Disease severity | CDR [57] | Descriptive, moderator | Patient | T0*, T2 |
| Cognitive status | MMSE [58] | Descriptive, moderator | Patient | T0*, T2 |
| Cognitive functioning | Standardized cognitive test battery [43]: RAVLT [59], VAT [60], DS [61], VF [62], LDST [63], SCWT [64], TMT [65] | Descriptive, moderator | Patient | T0* |
| Functional abilities | A-IADL-Q [66] | Descriptive, moderator | Caregiver | T0, T2 |
| Psychotropic medications | Brown bag review [20] | Descriptive, secondary outcome | Caregiver | T0, T1, T2 |
| Comorbidities | CIRS-G [50] | Descriptive | Patient | T0, T2 |
| Quality of life patient | QoL-AD [67] | Primary outcome | Patient and caregiver | T0, T1, T2 |
| Quality of life caregiver | CarerQol-7D [53] | Primary outcome | Caregiver | T0, T1, T2 |
| Caregiver burden | Perseverance time [68] | Secondary outcome | Caregiver | T0, T1, T2 |
| Caregiver competence managing NPS | Additional NPI-Q item [69] | Secondary outcome | Caregiver | T0, T1, T2 |
| Cost-effectiveness | Secondary outcome |
Patient Caregiver |
T0, T1, T2 | |
| NPS prevalence, severity, and distress | NPI-Q [44] | Secondary outcome | Caregiver | T0*, T1, T2 |
| If NPI-Q frequency score ≥ 1 on: | ||||
| “Agitation,” “motor disturbances,” “irritability,” “disinhibition” | Cohen-Mansfield Agitation Inventory [74] | Secondary outcome | Caregiver | T0, T1, T2 |
| “Apathy” | Apathy Evaluation Scale-I [75] | Secondary outcome | Caregiver | T0, T1, T2 |
| “Depression,” “anxiety,” “elation” | CSDD [76], RAID [77] | Secondary outcome | Caregiver | T0, T1, T2 |
| “Hallucinations,” “delusions” | BEHAVE-AD subscales psychosis, delusions [78] | Secondary outcome | Caregiver | T0, T1, T2 |
| “Nighttime behaviors” | Sleep Disorder Inventory [79] | Secondary outcome | Caregiver | T0, T1, T2 |
AD Alzheimer’s disease, CDR Clinical Dementia Rating, RAVLT Rey Auditory Verbal Learning Test, VAT Visual Association Test, DS Digit Span, VF Verbal Fluency (animals), LDST Letter Digit Substitution Test, SCWT Stroop Color Word Test, TMT Trail Making Test, MMSE Mini-Mental State Examination, A-IADL-Q Amsterdam Instrumental Activity of Daily Living Questionnaire, CIRS-G Cumulative Illness Rating Scale for Geriatrics, QoL-AD Quality of Life in Alzheimer’s Disease, iMTA iVIQ iMTA Valuation of Informal Care Questionnaire, iMTA MCQ iMTA Medical Costs Questionnaire, NPI-Q Neuropsychiatric Inventory Questionnaire, CSDD Cornell Scale for Depression in Dementia, RAID Rating Anxiety In Dementia, BEHAVE-AD Behavioral Pathology in Alzheimer’s Disease Rating Scale
*Will be carried out during the diagnostic procedure at local hospitals