Table 3 Planned future RCT outcomes
Measure | Description | Time point |
|---|---|---|
Proposed primary | ||
 Activities of daily living (ADL) with the Disability Assessment for Dementia (DAD) [41] | This will be assessed by the DAD which has a 40-item scale and address a range of functional domains. 17 items address basic ADLs and 23 items relate to Instrumental ADLs. Scores range from 0–100% witch higher percentage scores representing greater competence in ADLs | Baseline, 6 months |
Secondary | ||
 Activities of daily living (ADL) | As described above for primary outcome | Baseline, 3 months |
 Mobility | This will be assessed using the Timed Up and Go (TUG). Participants stand up and walk 3 m, turn around and walk back. The time taken to complete it is recorded. The test is scored as time in seconds | Baseline, 3 months, 6 months |
 Delirium persistence or recurrence | This will be assessed by DSM5 criteria [42], with some additional enhancements including use of the Informant Assessment of Geriatric Delirium scale (I-AGeD) [43] | Baseline, 3 months, 6 months |
 Attention | Assessment of attention using months of the year backwards. Participants will be asked to recite the months of the year backwards from December to June, and a score ranging from 0–7 represents number of months successfully recited before failure. A score of 7 indicates correct recital | Baseline, 3 months, 6 months |
 Level of arousal | Observational Scale of level of Arousal (OSLA) [44] will be used to assess the level of arousal in people with delirium | Baseline, 3 months, 6 months |
 Cognition | This will be assessed with mini ACE (Mini-ACE) [45] which consists of 5 items and has a maximum score of 30 | Baseline, 3 months, 6 months |
 Verbal fluency | Verbal fluency will be assessed using the ‘Animals’ item from the mini-ACE. The score represents the correct number of animals stated in 1 min | Baseline, 3 months, 6 months |
 Self-continuity | Single item question to assess sense of self-continuity. Scored on a Likert scale (Strongly disagree/disagree/neither agree nor disagree/agree/strongly agree) | Baseline, 3 months, 6 months |
 Verbal short-term and working memory | This will be assessed with the Digit span test (Forward Digit Span and Reverse Digit Span). Participants repeat a sequence of numbers in forward or reverse order. The length of digit span repeated correctly will be scored 0–8 | Baseline, 3 months, 6 months |
 Mood assessment | This will be assessed using Geriatric Depression Scale-4 (GDS-4) [46]. The 4 binary item scale will be used which has been validated in older people and people with dementia. The items will be summed to form a total score with a potential range of 0–4 | 3 months, 6 months |
 Wellbeing | This will be assessed using the ICEpop CAPability measure for Older people (ICECAP-O) [47] | Baseline, 3 months, 6 months |
 Residence category | Residence types (own home, living with family, assisted living/warden supported, care home without nursing, care home with nursing or other residence type) | 3 months, 6 months |
 Patient health-related quality of life (HRQL) | This will be assessed using the EQ-5D-5L and EQ-5D-5L proxy [39]. Participant responses to the EQ-5D-5L will be converted to health state values (HSVs) to provide quality-adjusted life-years (QALYs) | Baseline, 3 months, 6 months |
 Patient HRQL | This will be assessed with the DEMQOL and DEMQOL-Proxy [48] | Baseline, 3 months, 6 months |
 Carer burden | This will be assessed using the Zarit Burden Interview 12 (ZBI-12) [49]. 12 Items (rated 0–4) are summed to give a total score in the range 0–48 | Baseline, 3 months, 6 months |
 Carer quality of life | This will be assessed using the EQ-5D-5L. Carers participating in this study will be asked to report their own HRQOL, using the EQ-5D-5L, as described above | Baseline, 3 months, 6 months |
 Carer wellbeing | This will be assessed using the ICEpop CAPability measure for Adults (ICECAP-A) [50] | Baseline, 3 months, 6 months |
 Resource use | Data will be collected via a proxy Resource Use Questionnaire (RUQ). The RUQ will be informed by the ‘CORE Items for a Standardised Resource Use Measure (ISRUM)’ [37] and the Database of Instruments for Resource Use Measurement [38], and will be designed in collaboration with the PPIE group | Baseline, 3 months, 6 months |