Phase III outcome measures
| Domain | Measure | Items | Rater | Details |
| Cognition | Alzheimer’s Disease Assessment Scale—Cognitive Subscale (ADAS-Cog)32 | 21 | Person living with dementia (PwD) | Internationally recognised measure that includes three subscales: language, memory/new learning and praxis. It has been extensively validated in a range of settings and been adapted for use in in Sub-Saharan Africa as the main cognitive outcome in the IDEA study.33 This research is currently guiding adaptation work in India. |
| Quality of life | WHO Quality of Life- Bref (WHOQOL-BREF)34 | 26 | PwD | Consists of four domains: physical, psychological, social and environmental. Internal consistency for all domains is acceptable (α=>0.7) and the tool has been extensively validated across LMICs.35 Raw scores will be recorded (4–20), as per WHOQOL-Bref protocol. |
| Activities of daily living (ADLs) | EASY-Care Independence Scale (EASY-Care)36 | 18 | PwD | Developed from existing measures of ADLs, the measure uses a weighting system to measure dressing, bathing, housework, preparing meals and feeding. Total scores range from 0 to 100, with higher scores denoting greater degree of dependence. It has been validated in LMIC’s, most recently in India where internal consistency was reported as excellent. |
| Burden | Zarit Burden Interview (ZBI)37 | 22 | Caregiver | Rates the impact of a person’s disabilities on the caregivers’ life. Responses are rated from 0 to 4, with higher scores indicating greater burden. Internal consistency is excellent (α=0.92), however, despite some validation in LMICs including India,38 there is some evidence to suggest it is not cross-culturally valid. |
| Dementia Caregiver Experience Scale (DemCarES)39 | 17 | Caregiver | Due to potential issues with the ZBI, the DemCarES will also be utilised to assess caregiver burden. The CES was developed recently in India to account for the unusually low levels of burden documented by existing measures. Internal consistency has been found to be excellent (α=0.91) and the measure will be translated according to best practice and piloted in each of the countries. | |
| Cost-affordability | Client Services Receipt Inventory (CSRI)40 | N/A | Caregiver | The CSRI is used to collect information on service utilisation, income, accommodation and other cost-related variables. It has five sections consisting of: background information, accommodation and living situation, employment history, earnings and benefits, a record of services used and information about unpaid carers. Country-specific CSRIs will be used or developed over the course of the project. |
| Resource Utilisation in Dementia (RUD)41 | N/A | Caregiver | The RUD is designed for the collection of data pertaining to formal and informal care resource use across different countries and care systems. It includes items on accommodation, time spent assisting with activities of daily living and time spent assisting with instrumental activities of daily living. |
LMICs, low/middle-income countries.