Dementia
Conditions
Brief summary
Around 48 million people worldwide 1 live with dementia, of whom 3.9 million start with symptoms before the age of 65 (young-onset dementia). Most of the people presenting with young-onset dementia and some people with later onset dementia develop non-memory led dementias such as the atypical forms of Alzheimer ́s disease (AD)or frontotemporal dementia (FTD). Despite the proven benefits of educational programmes and skill training for caregivers, families of people with non-memory led dementias encounter fewer opportunities to receive this type of support. This is a significant gap in care considering that many people with young-onset non-memory led dementia are in their 50s or early 60s, which carries additional challenges about employment, financial stability, and childcare responsibilities. Finding suitable information and resources is less likely due to the lower prevalence of these phenotypes, their consequent geographical spread, and their atypical symptoms. Caregivers demands for more phenotype-specific support suggest that tailored provision of education and training is a gap in the provision of care in these types of dementia. The aim of this study is to: 1. Determine the effectiveness of the Better Living with Non-memory Dementia educational programme for caregivers in improving psychological outcomes \[WS1\]; and 2. Conduct a mixed methods process analysis to elucidate mechanisms of change, barriers and facilitators to access and implementation as well as perceived benefits and costs \[WS2\]. The design is a randomised waiting list control trial with an 8-week intervention and 6-month follow-up comparing intervention to standard care with embedded process analysis. The intervention comprises a virtual onboarding session with a facilitator, 6 learning modules (including module-end real-life tasks to put skills into practice) and up to two further virtual check-in sessions with the facilitator. Intervention adaptation, adaptation to design and selection of primary outcome measures was based on feasibility work.
Interventions
BEHAVIORALBetter Living with Non-memory led Dementia programme
an 8-week duration 6-module educational programme covering the following topics: 1) Welcome to the programme and what to expect from it; 2) Understanding the disease; 3) How to provide better support for the person with dementia; 4) How to look after the caregiver's own mental health; 5) Where to find additional sources of support, and 6) An introduction to the value of support groups. At the end of modules 2, 3, and 4, participants will be asked to complete a real-life task to put in practice skills learned in the specific module (e.g., approaching a friend and explaining the disease in lay terms). The first session (onboarding) will be facilitated via Zoom by one of the members of the research team. Up to 3 total interactions between facilitators and participants will be offered to support participants' engagement with the programme. All course modules will be printable using the pdf download button on the programme's page.
OTHERWaiting list
Signposting individuals to the publicly available Rare Dementia Support website. The control group will further receive access to the Better Living with Non-memory led Dementia programme after completing the collection of measures at 6 months.
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
It is not possible to blind the individual participants in this trial, but the individuals who will be analysing data or overseeing trial including health economists, co- investigators and trial statistician will remain blind until the blinded analysis detailed in the Statistical Analysis Plan has been conducted and reported to the trial team. The exception will be one of the co-investigators leading the process analysis.Unblinding will be performed following procedures outlined in NWORTH SOPs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults (18+) who self-identify as an unpaid carer (partners, children, friends, etc.) of someone with PPA, PCA or bvFTD who is not living in a full-time care facility. 2. The care recipient must have a confirmed diagnosis of dementia (through self-report of the carer, to reflect the 'real world' application of the intervention). 3. Able to give informed consent. 4. Good comprehension of written English. 5. Access to the internet.
Exclusion criteria
1. Carers of people living with dementia in full-time care facility. 2. Carers of people with severe dementia in terms of large impact on activities of daily living. 3. Carers of individuals with any form of dementia other than PPA, PCA, or bvFTD. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ 9) | 8 weeks | Are Patient Health Questionnaire (PHQ 9) scores significantly decreased in caregiver participants allocated to receive the intervention compared to participants allocated to a waiting list control group. Scores can range from 0 to 27. Higher score mean worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS) | 8 weeks | Measures perceived stress. Scores can range from 0 to 40. Higher score mean worse outcome. |
| Caregiver Self-efficacy Scale (CSES-8). Scores can range from 1 to 10. Higher score mean better outcome. | 8 weeks | Measures perceived caregiver self-efficacy |
| Quality of Carer-Patient relationship (QCPR) | 8 weeks | Measures the quality of the carer patient relationship. Scores can range from 14 to 70. Higher score mean better outcome. |
| Health related quality of life (EQ5D5L) | 8 weeks | EuroQol Group tool to measure quality of life related to health outcomes. Scores can range from 5 to 25. Higher score mean better outcome. |
| ICEpop Capability measure for adults (ICECAP-A) | 8 weeks | Measures capability for the general adult population for use un economic evaluation. Scores can range from 5 to 25. Higher score mean better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews | week 8 and 24 | Semi-structured interviews will be conducted with a subset of participants who complete the BELIDE intervention, to explore their experiences of using the online tool, perceived benefits or challenges, and its impact on their caregiving role. |
Countries
United Kingdom
Outcome results
None listed