Clinical trial NCT06241287: BELIDE: Better Living With Non-memory-led Dementia
Official title: Better Living With Non-memory-led Dementia: a Randomised Controlled Trial of a Web-based Caregiver Educational Programme
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.
6. Having a minimum amount of input in the care of the person with dementia (weekly contact).

Exclusion Criteria:

1. Carers of people living with dementia in full time care facility.
2. Carers of a people with severe dementia in terms of large impact on activities of daily living. -

Primary outcomes:
measure: Patient Health Questionnaire (PHQ 9)
timeFrame: 8 week
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: 8 week
measure: Caregiver Self-efficacy Scale (CSES-8). Scores can range from 1 to 10. Higher score mean better outcome.
timeFrame: 8 week
measure: ICEpop Capability measure for adults (ICECAP-A)
timeFrame: 8 weeks
measure: Quality of Carer-Patient relationship (QCPR)
timeFrame: 8 week
measure: Health related quality of life (EQ5D5L)
timeFrame: 8 week
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
References: