BELIDE: Better Living With Non-memory-led Dementia

NCT06241287 | Recruiting DMC

• 1 other identifier: 8545/007
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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. 1.Determine the effectiveness of the Better Living with Non-memory Dementia educational programme for caregivers in improving psychological outcomes \[WS1\]; and
2. 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 \[WS2\].

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ 9)

  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.

  8 weeks

Secondary Outcomes (5)

• Perceived Stress Scale (PSS)

  8 weeks

• Caregiver Self-efficacy Scale (CSES-8). Scores can range from 1 to 10. Higher score mean better outcome.

  8 weeks

• ICEpop Capability measure for adults (ICECAP-A)

  8 weeks

• Quality of Carer-Patient relationship (QCPR)

  8 weeks

• Health related quality of life (EQ5D5L)

  8 weeks

Other Outcomes (1)

• Qualitative interviews

  week 8 and 24

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive the 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.

Behavioral: Better Living with Non-memory led Dementia programme

Control group

OTHER

The waiting list control group will receive signposting to the publicly available Rare Dementia Support website (https://www.raredementiasupport.org/) and any kind of support the participants may already being receiving (e.g. psychological support, online information, support groups, etc). This a wait list study where the control group will be given access to the intervention ́s educational modules and material after the individuals' last point of data collection.

Other: Waiting list

Interventions

Better Living with Non-memory led Dementia programme BEHAVIORAL

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.

Intervention group

Waiting list OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, WC1N 3BG, United Kingdom

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: February 5, 2024
• Study Start: January 29, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)