Table 1 Summary of visits and content
Instrument | Assessment | Timing of assessment |
|---|---|---|
Inclusion form | Eligibility criteria | Previous to randomization |
Sociodemographic form of patient and caregiver | Sociodemographic data | Basal |
Baseline clinical data form | Treatment for dementia Diseases and concomitant treatments | Basal |
Institucionalization form | Institutionalization date | 1,3,6 & 12 months (study end) |
SMMSE | Cognitive assessment | Basal, 1,3,6 & 12 months (study end) |
BADLS | Functional assessment | Basal, 1,3,6 & 12 months (study end) |
FAST | Functional assessment | Basal & 12 months (study end) |
QUALID | Advanced dementia quality of life | Basal, 1,3,6 & 12 months (study end) |
EQ-5D | Quality of life related to health | Basal & 12 months (study end) |
NPI-Q | Psychological and behavioral symptoms associated to dementia | Basal, 1,3,6 & 12 months (study end) |
Zarit Scale | Caregiver overload | Basal, 1,3,6 & 12 months (study end) |
CGIC | Clinical improvement impression | 12 months (study end) |
RUD Lite | Use of health resources in dementia | 12 months (study end) |
Adverse effects forms | Safety, adverse effects and mortality | 1,3,6 & 12 months (study end) |