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

Not Applicable

Completed

• Conditions: Dementia; Mental and Behavioural Disorders

• Registration Number: ISRCTN58330068
• Lead Sponsor: Aston University

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27009145 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30340480 results (added 10/09/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32122341/ (added 08/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-30
• Study Start: 2017-10-05
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europsychiatric 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.