Lived Experience Narratives in Dementia

NCT07757178 | Recruiting DMC

• 2 other identifiers: IRAS351969NIHR206255
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The Lived Experience Narratives in Dementia (LEND) research programme involves five work packages (WP). WP1 explores how people living with dementia use narratives and how narratives can impact them. Findings will support the development of LEND theory. WP 2-3 focus on developing the digital Online LEND Intervention, assessing its usability and acceptability, and conducting a feasibility study within NHS memory assessment and community services. Activities across the first three WPs include interviews, focus groups, user-testing sessions, engagement evaluation interviews, and a two-arm randomised feasibility trial using a range of outcome measures. Findings from this stage will inform refinement of the intervention and determine the feasibility of progressing to a future randomised controlled trial (RCT) of the Online LEND Intervention. WP4 is the Online LEND Intervention two-arm RCT. WP5 involves dissemination. The protocol for WP4 and 5 have not yet been developed and rely on results from WP1-3.

Conditions

Dementia; Neuro-Degenerative Disease; Alzheimer Disease; Caregiver Burden; Caregiver Burnout

Outcome Measures

Primary Outcomes (2)

• Quality of Life (QoL-AD)

  The Quality of Life in Alzheimer's Disease (QoL-AD) scale is a validated measure captures wellbeing across multiple domains including mood, relationships, daily activities, memory, and overall life satisfaction. The feasibility study will assess completeness of data, variability, and acceptability of QoL-AD as the primary endpoint for a future definitive RCT.

  Baseline and Six Months

• Mental Wellbeing (SWEMWBS)

  The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). This seven-item scale assesses emotional functioning, optimism, and psychological wellbeing. The feasibility study will evaluate suitability, recruitment, retention, and response characteristics of SWEMWBS as the primary carer outcome for the full trial.

  Baseline and Six Months

Secondary Outcomes (2)

• Engagement and Independence in Dementia Questionnaire (EID-Q)

  Baseline and Six Months

• Rosenberg Self-Esteem Scale - Brief Version (RSES)

  Baseline and Six Months

Other Outcomes (7)

• General Self-Efficacy Scale (GSES)

  Baseline and Six Months

• Caregiver Self-Efficacy Scale (CSES)

  Baseline and Six Months

• Zarit Burden Interview - Short Version (ZBI-12)

  Baseline and Six Months

Study Arms (2)

Online LEND Intervention

EXPERIMENTAL

Participants in WP3, the feasibility trial, are allocated to this arm receive access to the LEND digital intervention. The intervention consists of a web-based platform that provides personalised lived-experience narratives curated for people with dementia and their family carers. Content includes written, audio, and video narratives covering themes such as coping strategies, identity, emotions, daily living, social relationships, and adjusting to diagnosis. Participants are able to browse and select narratives; receive recommendations based on preferences; bookmark or rate content; and use accessibility features designed to support cognitive needs, including simplified navigation, adjustable text, and audio playback. The intervention is used independently at home for 4 to 6 weeks, with no minimum usage requirement. Participants also complete baseline and follow-up outcome measures through the integrated LEND Portal prior to randomisation.

Behavioral: Online LEND Intervention

Treatment as Usual

NO INTERVENTION

Participants randomised to this arm continue to receive their standard care and support as normally provided. This may include by NHS Memory Assessment Services, community mental health teams, primary care, and other relevant voluntary-sector and non voluntary-sector organisations. They do not receive access to the Online LEND Intervention during the feasibility study period. Prior to randomisation, participants complete the same baseline outcome measures. Access to the LEND portal, but not the Online LEND Intervention, is continued as follow-up outcome measures are required after 6 months period, paralleling the intervention arm.

Interventions

Online LEND Intervention BEHAVIORAL

The Online LEND Intervention is a web-based platform that provides personalised lived-experience narratives for people with dementia and their carers. It aims to support wellbeing, confidence, and self-efficacy by offering relatable stories from others with similar experiences. The final design is still in development but is expected to include personalised recommendations, simplified navigation, adjustable text, audio playback, captioning, and content warnings. Users will be able to bookmark, rate, or hide stories and access the intervention independently at home over a 4 to 6-week period. The platform will be accessed via the secure LEND Portal, where participants also complete study measures. LEND does not provide clinical advice; it offers supportive, ethically reviewed narratives to promote connection and empowerment.

Online LEND Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18+.
• Able to give informed consent and participate meaningfully in the required tasks.
• Adequate communication ability in the required study language

You may not qualify if:

• Living in a hospital or healthcare institution at the time of the study.
• Refusal or inability to provide informed consent, or lack of capacity to consent.
• Inability to comprehend participant information or communicate meaningfully

Sponsors & Collaborators

• University of Nottingham: lead
• Nottinghamshire Healthcare NHS Trust: collaborator

Study Sites (2)

Mental Health & Clinical Neurosciences, Institute of Mental Health

Nottingham, England, NG7 2TU, United Kingdom

RECRUITING

Nottinghamshire Healthcare NHS Foundation , Highbury Hospital

Nottingham, NG6 9DR, United Kingdom

RECRUITING

Related Links

• Dementianarratives.org is the LEND website that tells people about what the currently status of LEND is and what research findings have been made.

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Martin Orrell

  University of Nottingham

  STUDY DIRECTOR

Central Study Contacts

Linda E O'Raw, PhD

CONTACT

07791598280; linda.o'raw@nottingham.ac.uk

Mark Howells

CONTACT

mark.howells@nottshc.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This feasibility study uses single-blind outcome assessment. Participants and the research team delivering the intervention are not blinded due to the nature of the digital intervention and its use in participants' homes. However, quantitative data analysis is conducted by statisticians who are blinded to group allocation, with intervention and control groups coded numerically during analysis. Qualitative researchers conducting follow-up interviews are also independent of the randomisation process. Randomisation is automated via a secure, concealed allocation system managed by the Bangor Clinical Trials Unit to prevent foreknowledge of assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In WP3, this study uses a two-arm parallel-group randomised feasibility design in which participants are allocated 1:1 to either the Online LEND Intervention or a Treatment-as-Usual (TAU) control group. The purpose of the design is not to test clinical effectiveness but to evaluate the feasibility and acceptability of trial procedures, including recruitment, randomisation, retention, data collection, participant engagement, and outcome measure completion. Randomisation is stratified by whether the person with dementia has a co-resident carer, and allocation is performed using a secure, automated computerised system managed by the Bangor Clinical Trials Unit. Analysts and outcome assessors are blinded to group allocation. The results of this feasibility randomised trial will be used to inform the design and delivery of a future fully powered randomised controlled trial.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 11, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)