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

Overview

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

• Behavioral Better 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 s
• Other Waiting 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.

Primary outcome measures

• Patient Health Questionnaire (PHQ 9) [Time frame: 8 weeks]

Secondary outcome measures (5)

• Perceived Stress Scale (PSS) [Time frame: 8 weeks]
• Caregiver Self-efficacy Scale (CSES-8). Scores can range from 1 to 10. Higher score mean better outcome. [Time frame: 8 weeks]
• ICEpop Capability measure for adults (ICECAP-A) [Time frame: 8 weeks]
• Quality of Carer-Patient relationship (QCPR) [Time frame: 8 weeks]
• Health related quality of life (EQ5D5L) [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.
• 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).
• Able to give informed consent.
• Good comprehension of written English.
• Access to the internet.

Exclusion criteria

• Carers of people living with dementia in full-time care facility.
• Carers of people with severe dementia in terms of large impact on activities of daily living.
• Carers of individuals with any form of dementia other than PPA, PCA, or bvFTD. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• University College London — London

Publications

• Cullen K, Brotherhood EV, Hayes O, Mansfield V, Suarez-Gonzalez A, Zimmermann N, Stott J, Fitzsimmons D. Development of a resource use measure to capture costs related to unpaid care for people living with non-memory led dementia: a modified Delphi study. BMJ Open. 2026 Feb 12;16(2):e110399. doi: 10.1136/bmjopen-2025-110399. PMID 41688103
• Suarez-Gonzalez A, Brotherhood E, John A, Hayes O, Rossi-Harries S, Zimmermann N, Mansfield V, Brand A, Hoare Z, Fitzsimmons D, Cullen K, Crutch S, Stott J. Better Living with Non-memory-led Dementia: study protocol for a randomised controlled trial of a web-based caregiver educational programme (BELIDE trial). BMJ Open. 2025 Sep 5;15(9):e102518. doi: 10.1136/bmjopen-2025-102518. PMID 40912705

Identifiers

NCT: NCT06241287 · 8545/007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗