Delirium Mental and Behavioural Disorders Delirium, unspecified
Conditions
Interventions
Study design:
1. A feasibility study to see if the intervention is acceptable to participants, sufficient numbers of participants can be recruited and given the intervention and sufficient outcome dat
Sponsors
Royal Devon University Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 01/11/2023: Patients: 1. Aged over 65 years 2. Admitted to an acute hospital 3. Clinical diagnosis of delirium while admitted to hospital 4. Expected to be living in a private dwelling after discharge from hospital or immediate care (a period of 4 weeks of intermediate care will be allowed before discharge home) 5. Has a carer who could be approached for the study 6. Has the capacity to provide informed consent to participate, OR, has a consultee who is able to give an opinion on the participation of the person with delirium (in England), OR, has a relative/welfare guardian who is able to give informed consent on behalf of the person with delirium (in Scotland). 7. Lives within the geographical boundary of the local intervention delivery team Carers: 1. Family member or friend of the person with delirium 2. In contact with patient participant for at least one hour per week 3. Able to communicate in English sufficiently well to complete the proxy outcome measures 4. Has the capacity to provide informed consent. Previous participant inclusion criteria: Patients: 1. Aged over 65 years 2. Admitted to an acute hospital 3. Clinical diagnosis of delirium lasting for more than 48 hours 4. Expected to be living in a private dwelling after discharge from hospital or immediate care (a period of 4 weeks of intermediate care will be allowed before discharge home) 5. Has a carer who is willing to assist with the completion of outcomes 6. Has the capacity to provide informed consent to participate, OR, has a consultee who is able to give an opinion on the participation of the person with delirium (in England), OR, has a relative/welfare guardian who is able to give informed consent on behalf of the person with delirium (in Scotland) Carers: 1. Family member or friend of the person with delirium who is going to take part in the study 2. In contact with patient participant for at least 1 hour per week 3. Able to communicate in English sufficiently well to complete the proxy outcome measures 4. Has the capacity to provide informed consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 01/11/2023: Patients: 1. Diagnosis of delirium cannot be confirmed during the patient’s hospital visit 2. Unable to communicate verbally due to advanced dementia or aphasia 3. Carer declines participation in the study 4. Undergoing end-of-life care 5. Participating in another intervention study Carers: There are no exclusion criteria for carer participants Previous participant exclusion criteria: Patients: 1. Diagnosis of delirium cannot be confirmed during the patient’s hospital visit 2. Unable to communicate verbally due to advanced dementia or aphasia 3. Carer declines participation in the study 4. Undergoing end-of-life care 5. Participating in another intervention study Carers There are no exclusion criteria for carers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of people with delirium identified on hospital wards will be measured with a screening log pre-baseline 2. The proportion (and number) of people with delirium who meet the eligibility criteria will be measured with a screening log pre-baseline 3. The proportion of eligible people with delirium who agree to participate in the study will be measured with a screening log pre-baseline 4. The proportion of carers who agree to participate in the study will be measured with a screening log pre-baseline 5. The proportion of participating people with delirium who start the intervention will be measured with an intervention case report form (CRF) at 2 weeks post-discharge 6. The proportion of participating people who complete =60% of the intervention sessions will be measured with an intervention CRF at 3 months post-discharge 7. The proportion of participating people with delirium who remain in the study until the final follow-up at 6 months 8. The proportion of people with delirium providing valid outcome data for each primary and secondary outcome measure at 3 and 6 months post-discharge 9. The acceptability of the intervention will be assessed using a qualitative process evaluation post-intervention 10. The estimated standard deviation and 6-month follow-up rate for the proposed primary outcome, in order to either verify or inform the revision of the proposed sample size calculation for the definitive RCT The primary outcome measure for the randomised controlled trial: 1. Activities of daily living (ADL) measured using the Disability Assessment for Dementia (DAD) tool at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Activities of daily living (ADL) measured using the Disability Assessment for Dementia (DAD) tool at baseline and 3 months 2. Mobility assessed using the Timed Up and Go (TUG) at baseline, 3 and 6 months 3. Delirium persistence or recurrence based on the protocol previously published for the Delirium and Cognitive Impact in Dementia (DECIDE) study in which diagnosis is made according to DSM5 criteria, with some additional enhancements including the use of the Informant Assessment of Geriatric Delirium scale (I-AGeD), at baseline, 3 and 6 months 4. Attention assessed by reciting the number of months of the year backwards at baseline, 3 and 6 months 5. Arousal assessed using the Observational Scale of level of Arousal (OSLA) at baseline, 3 and 6 months 6. Cognition assessed with mini ACE at baseline, 3 and 6 months 7. Verbal fluency assessed using the ‘Animals’ assessment from the mini-ACE assessment at baseline, 3 and 6 months 8. Identity self-continuity assessed using a single question scored on a Likert scale (Strongly disagree/disagree/neither agree nor disagree/agree/strongly agree) at baseline, 3 and 6 months 9. Verbal short-term and working memory assessed with the Digit span test (Forward Digit Span and Reverse Digit Span) at baseline, 3 and 6 months 10. Mood assessed with the Geriatric Depression Scale-4 (GDS-4) at 3 and 6 months 11. Wellbeing assessed with the ICEpop CAPability measure for Older people (ICECAP-O) at baseline, 3 and 6 months 12. Residence category assessed using a record of whether the patient participant is living in their own home, living with family, assisted living/warden supported, care home without nursing, care home with nursing or other residence type at 3 and 6 months 13. Patient health-related quality of life (HRQL) assessed with the EQ-5D-5L and EQ-5D-5L proxy at baseline, 3 and 6 months 14. Patient HRQoL assessed with the DEMQOL and DEMQOL-Proxy at baseline, 3 and 6 months 15. Carer burden assessed with the Zarit burden intervi | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed