Dementia Mental and Behavioural Disorders
Conditions
Interventions
Study design:
- Deliver a pilot cluster randomised control trial of an intervention to maintain independence in People With Dementia (PWD), living in their own homes, who have already fallen
- Recruit
Sponsors
Royal Devon University Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
50 Years to 110 Years
Inclusion criteria
Inclusion criteria: Patients: 1. A diagnosis of dementia made prior to entry into the study. PWD must be on the Primary Care Quality Outcomes Framework (QOF) Dementia register. 2. Must have sustained at least one fall within 6 months prior to identification as a potential study participant. A fall is defined as an event whereby a person comes to lie on the ground or another lower level with or without loss of consciousness. 3. Must be dwelling in their own home at the time of the index fall and returning to their own home at the time of the intervention 4. Must have an unpaid carer available to assist with the completion of the diaries 5. Either has the capacity to consent to participation, or a personal or nominated consultee who is able to give an opinion on the participation of the PWD 6. Able to communicate in English 7. Aged over 50 years Carers: 1. Family member or friend of the PWD patient participant 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: Patients: 1. Diagnosis of dementia cannot be confirmed by the primary care team within 4 weeks of their being identified 2. PWD found to be dwelling in a care home or to have been a hospital inpatient at the time of the index fall 3. PWD refuses consent or lacks capacity and does not have a personal or nominated consultee, or their personal or nominated consultee declines participation 4. Unpaid carer declines participation in the study Carers: There are no exclusion criteria for carer participants
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Mobility assessed using the timed up and go at baseline and 6 months 2. Patient participant rated quality of life assessed with the European Quality of Life Instrument (EQ-5D-5L) at baseline and 6 months 3. Patient participant rated quality of life assessed with the Quality of Life - Alzheimer’s Disease (QOL-AD) at baseline and 6 months 4. Psychological consequences of falling assessed with the International short form Falls Efficiency Scale (Short-FES-I) at baseline and 6 months 5. Cognition assessed with mini ACE (Mini-ACE) at baseline 6. Assessing the extent goals are achieved using Goal Attainment Scaling (intervention only) at baseline and 6 months 7. Number of falls assessed with the falls diary throughout 6-month follow-up 8. Carer burden assessed with the Zarit burden interview 12 (ZBI-12) at baseline and 6 months 9. Carer participant rated quality of life assessed with the European Quality of Life Instrument (EQ-5D-5L) at baseline and 6 months 10. Carer-rated patient participant quality of life assessed with the EQ-5D-5L proxy at baseline and 6 months 11. Carer-rated patient participant quality of life assessed with the Quality of Life - Alzheimer’s Disease (QoL-AD) Proxy at baseline and 6 months 12. Health and social care utilisation assessed with the Health and social care Utilisation Questionnaire (HUQ) at baseline, 3 month follow up and 6 month follow up | — |
Primary
| Measure | Time frame |
|---|---|
| Activities of daily living (ADL) assessed with the Disability Assessment for Dementia (DAD) at baseline, and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed