DPACT dementia support study

Not Applicable

Completed

• Conditions: Dementia; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN80204146
• Lead Sponsor: Devon Partnership NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-23
• Study Completion: 2022-06-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

People living with dementia† (people with a formal diagnosis of dementia regardless of specific type) and significant cognitive problems which could indicate dementia and their carer‡, resident within the local authority boundary to be served. The programme also aims to investigate ways in which people with dementia without a carer can be included.

†Dementia is a broad term used to describe a range of neurodegenerative disorders which may include but will not be limited to: Alzheimer's disease (AD); Late Onset Alzheimer’s disease (LOAD); Early Onset Alzheimer’s disease (EOAD); Vascular dementia (VAD); Mixed dementia (AD with VAD); Dementia with Lewy bodies (LBD); Frontotemporal dementia (FTD); Parkinson’s disease dementia (PDD).

‡Carers in this context are defined as the primary person who feels responsible for, and supports, the person with dementia”. Inclusion criteria need to be constructed that do not exclude participants that are representative of the target population and stand to benefit most from the intervention. We need to avoid waste of resources and unnecessary burden on patients by not including those at a disease stage so mild that it precludes benefit. Inclusion criteria will require careful consideration from practical perspectives. Roughly one third of people with dementia live alone and while some may still have an active and engaged carer, it is likely that assistance received is more variable than in dyads where the carer is cohabitating. This may also influence engagement with a Dementia Support Worker intervention. There is also a higher trial dropout rate associated with people with dementia with non-spousal carers.

While the intention is to include such individuals in the trial, it will be necessary to explore the mechanisms of the intervention in the context of variable carer capacity and care-delivery; the proxy reporting capacity of the carer will need to be considered with regard to valid outcome completion. This is one of the key aspects of the intervention that the Peer Research Group will be engaged with.

Exclusion Criteria

Current exclusion criteria as of 27/10/2020:
1. Those who are resident outside the local authority boundary to be served
2. Those currently undergoing emergency treatment or care
3. Those within care home setting
4. Those who score mild or non-impaired a cognitive screening assessment

Previous exclusion criteria:
1. Those who are resident outside the local authority boundary to be served
2. Those currently undergoing emergency treatment or care
3. Those within care home setting

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is a feasibility study and as such there is no primary outcome. The proportion of individuals likely to have dementia recruited into the study is the key quantitative measure to be calculated.<br>The primary outcome measure for the later main trial will be quality of life for the person with dementia and their carer.

Secondary Outcome Measures

Name	Time	Method
The appropriateness of the specific outcome measures is one of the research questions which this study will address. The following outcome measures are potential candidates for key domains and will be collected during recruitment. The researchers will test out these as listed and these may change as a result of the research process and any changes will be subject to amendment:<br>1. Functional impairment measured using the Bristol Activities of Daily Living Scale (BADLS)<br>2. Behavioural and psychological symptoms measured using the Neuro Psychiatric Inventory (NPI)<br>3. Dementia-related quality of life measured using the Dementia Quality of Life scale (DEMQOL and DEMQOL-Proxy)<br>4. Carer well-being is measured using the Carer Well-being and Support (CWS) Questionnaire<br>5. Cognition measured using the Addenbrooke's Cognitive Examination (ACE) Mobile<br>Measured at baseline and 2-9 months