DementiaBELIDENCT06241287
BELIDE: Better Living With Non-memory-led Dementia
A study testing Better Living with Non-memory led Dementia programme and Waiting list in people with Dementia, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Better Living with Non-memory led Dementia programme and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London, WC1N 3BG
Aida Suarez-Gonzalez, Dr, +44 (0)20 3448 4773, aida.gonzalez@ucl.ac.uk
+44 (0)20 3448 4773
About this study
Official title: Better Living With Non-memory-led Dementia: a Randomised Controlled Trial of a Web-based Caregiver Educational Programme
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:
Read more
- Determine the effectiveness of the Better Living with Non-memory Dementia educational programme for caregivers in improving psychological outcomes [WS1]; and
- 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.
- Conditions
- Dementia
- Being tested
- Better Living with Non-memory led Dementia programme, Waiting list
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Better Living with Non-memory led Dementia programmeBehavioural
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.
Waiting listOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
Perceived Stress Scale (PSS)
Measures perceived stress.
Scores can range from 0 to 40. Higher score mean worse outcome.
Measured: 8 weeks
Caregiver Self-efficacy Scale (CSES-8). Scores can range from 1 to 10. Higher score mean better outcome.
Measures perceived caregiver self-efficacy
Measured: 8 weeks
ICEpop Capability measure for adults (ICECAP-A)
Measures capability for the general adult population for use un economic evaluation.
Scores can range from 5 to 25. Higher score mean better outcome.
Measured: 8 weeks
Quality of Carer-Patient relationship (QCPR)
Measures the quality of the carer patient relationship.
Scores can range from 14 to 70. Higher score mean better outcome.
Measured: 8 weeks
Health related quality of life (EQ5D5L)
EuroQol Group tool to measure quality of life related to health outcomes.
Scores can range from 5 to 25. Higher score mean better outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start29 Jan 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241287
- Sponsor's protocol ID
- 8545/007
- Acronym
- BELIDE
- Status last verified
- Aug 2025
- First submitted
- 3 Jan 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41688103Suarez-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.
PubMed 40912705
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Living With Non-memory-led Dementia: a Randomised Controlled Trial of a Web-based Caregiver Educational Programme
- ClinicalTrials.gov ID
- NCT06241287
- Acronym / sponsor ID
- BELIDE / 8545/007
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the effectiveness of the Better Living with Non-memory Dementia educational programme for caregivers in improving psychological outcomes [WS1]; and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Better Living with Non-memory led Dementia programmeThe 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. |
| Control group | Other | Other: Waiting listThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Better Living with Non-memory led Dementia programmean 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. | Behavioural | Intervention group |
| Waiting listSignposting 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. | Other | Control group |
Primary outcome
Patient Health Questionnaire (PHQ 9)
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 41688103Cullen 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.
- Derived from this study: PubMed 40912705Suarez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better Living with Non-memory led Dementia programme and Waiting list in people with Dementia, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ 9) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241287, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.