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Improving the management of behaviour that challenges associated with dementia in care homes: testing the feasibility of a combined pharmacy-health psychology intervention

Improving the management of behaviour that challenges associated with dementia in care homes: a pharmacy-health psychology intervention feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN58330068
Enrollment
45
Registered
2017-10-05
Start date
2016-02-01
Completion date
Unknown
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia Mental and Behavioural Disorders Dementia

Interventions

The study involves: For people with dementia - a medication review to support appropriate prescribing by an experienced specialist pharmacist. Follow-up to assess the impact of the med

Sponsors

Aston University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Receiving medication (including but not limited to medicines in British National Formulary [BNF] sections 4.1/4.2/4.3/4.11) to treat behaviour that challenges 2. Resident within a long-term care facility 3. Registered with a West Midlands GP (who has also agreed to participate) 4. Dementia confirmed (dementia register, documentation of relevant read codes, confirmation of diagnosis via communication from old age psychiatry, memory clinic or clinical psychologist) 5. Patient or personal consultee willing to provide consent/assent 6. A proxy informant (key worker or staff member with close working relationship) who can clearly communicate in English available

Exclusion criteria

Exclusion criteria: 1. Patient or personal consultee unable or unwilling to provide consent or lacks necessary English-language skills 2. On palliative care register, or has pathology requiring complex specialist medication 3. Risk of harm in line with Alzheimer Society guidance (guidelines published in 2011, currently being updated and therefore not available) 4. Severe mental illness (e.g. schizophrenia) where psychotropic treatment should be continued

Design outcomes

Primary

MeasureTime frame
Neuropsychiatric symptoms, assessed using the Neuropsychiatric Inventory (NPI). A specific nursing home version (NPI-MH) designed for interviewing professional care staff will be used. The decrease in the NPI-MH change score between baseline and 3 months will be the primary measure; it will also be collected at 6 weeks and 6 months. A decrease in 4 points, or more will be considered a clinically meaningful change in the NPI-NH.

Secondary

MeasureTime frame
Collected at baseline (before the medication review), 6 weeks and 3 and 6 months (unless stated): 1. Quality of life (QoL), measured using DEMQoL and EuroQoL EQ-5D (proxy versions). Participants may not be able to respond and to reduce any “proxy effect” caregivers will be requested to respond “as if” they were the person with dementia (EQ-5D only collected at baseline, 3 and 6 months; DEMQoL collected at all time points) 2. Cognitive test: standardised Mini-Mental State Examination (sMMSE) collected at baseline, 6 weeks and 3 months) 3. All prescribed medication 4. Costs: a modified version of the Client Services Receipt Inventory (CSRI) will be used to monitor levels of resource use associated with the medication review (including preparation and recommendations) and the use of other NHS and PSS (Personal Social Services) resource items e.g. medication utilisation, GP services and hospital visits/admissions. This will be completed by proxy. Only collected at baseline, 3 and 6 months

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026