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RecruitingNCT07757178LENDUpdated Aug 11, 2026

Lived Experience Narratives in Dementia

An interventional study of Online LEND Intervention in Dementia, Neuro-Degenerative Disease and Alzheimer Disease, sponsored by University of Nottingham. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by University of Nottingham · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

Study Overview The Lived Experience Narratives in Dementia (LEND) Programme is a five-year NIHR-funded research programme designed to develop, optimise, and evaluate a novel digital intervention that delivers personalised lived-experience narratives to people living with dementia and their carers. The ultimate goal is to improve wellbeing and quality of life by providing accessible, relatable, and culturally diverse narratives that promote hope, self-efficacy, independence, and emotional support.

Packages (WP) 1-3, includes theory development (WP1), intervention development (WP2), and a randomised controlled feasibility study with long-term follow-up interviews (WP3).

LEND prioritises inclusion of under-served communities, including Black and South Asian groups, LGBT+ communities, people with young-onset dementia, and people with rarer dementias (see LEND WP1-3 Protocol v1.0 CLEAN).

WORK PACKAGE 1: Development of LEND Theory WP1 develops the theoretical foundations that shape the design and content of the LEND digital intervention. It consists of five interconnected sub-work packages, each addressing a different element of user experience, narrative relevance, and contextual factors affecting engagement.

WP1.1: Online or Paper Survey (WP1.1O / WP1.1P) Purpose: To understand how people living with dementia and carers use social media, technology, and online resources over time.

Design: A continuous cross-sectional survey, recruiting ≥300 participants per year over five years (minimum n=1,500 total) LEND WP1-3 Protocol v1.0 CLEAN

Focus:

  • Patterns of online behaviour
  • Barriers and facilitators to digital engagement
  • Types of narratives accessed, preferred formats, and comfort levels with online content

WP1.2: Semi-Structured Interviews Purpose: To explore how lived-experience narratives may benefit people living with dementia and carers, informing LEND theory.

Sample: n=30 (15 people with dementia; 15 carers) LEND WP1-3 Protocol v1.0 CLEAN

Focus:

  • Perceived use and impact of narratives
  • Digital literacy, accessibility, and digital poverty

WP1.3a: Narrative Impact Validation Purpose: To test how participants engage with up to five lived-experience narratives selected from an initial pool of \~30 narratives, including those from ethnic minority and under-served groups.

Sample: n=40 (20 people with dementia; 20 carers) LEND WP1-3 Protocol v1.0 CLEAN

Focus:

  • Emotional and cognitive responses to narratives
  • Comprehension, resonance, and perceived relevance
  • The development of criteria
  • Safety considerations (e.g., triggering material, content warnings)

WP1.3b: Narrative Rating Purpose: To develop a categorisation framework for dementia narratives based on user ratings and feedback.

Sample: Repeat measures from WP1.3a.

Focus:

  • Narrative qualities (tone, genre, turning points, themes)
  • Degree of helpfulness, clarity, relatability
  • Score or rate different types of narrative
  • User preferences to inform algorithmic recommendations

WP1.4: Focus Groups Purpose: Conducted in collaboration with the Centre for Ethnic Health Research, WP1.4 prioritises inclusion of Black, South Asian, and other under-served communities.

Sample: Four focus groups (n=40 total) LEND WP1-3 Protocol v1.0 CLEAN

Focus:

  • Cultural perceptions of dementia
  • Barriers to accessing support and digital interventions
  • Relevance, acceptability, and cultural safety of narratives

WP1.5: Discrete Choice Experiment (DCE) Purpose: To determine which narrative features are most valued by people with dementia, carers, and the general public.

Sample:

  • n=10 people with dementia
  • n=10 carers
  • n=10 general public LEND WP1-3 Protocol v1.0 CLEAN

Focus:

  • Trade-offs between different narrative types
  • Preferences relating to narrator characteristics, narrative tone, format, and content
  • Input directly informing later intervention design

WORK PACKAGE 2: Development of LEND Intervention WP2 focuses on building the digital intervention through iterative, user-centred development.

WP2.3: Development of the LEND Digital Intervention WP2.3 is a multi-phase iterative development process consisting of workshops, prototype development, usability testing, accessibility refinement, and preparation for feasibility evaluation.

Phase 1: Co-production Workshops (Months 10-12)

Using LEAP (Lived Experience Advisory Panel) members and developers:

  • Identify essential features of the LEND Portal and Online LEND Intervention
  • Determine accessibility requirements and inclusive design priorities Phase 2: First Working Version (Months 12-14)
  • Build initial prototype of the LEND web application
  • Conduct first stage of usability testing with n=20 participants (10 carers, 10 people with dementia)
  • Develop expert rules for relevance-based narrative retrieval Phase 3: Second Working Version \& Testing (Months 14-18)
  • Refine interface based on feedback
  • Achieve AA-level accessibility compliance (WCAG \& EN 301 549)
  • Conduct second usability testing cycle with n=20 (balanced sample) Phase 4: Third Working Version (Months 18-36)
  • Produce pre-feasibility version of intervention
  • Conduct in-vivo user testing
  • Recruit from earlier phases to conduct extended testing

Key Features of Intervention (developed across WP2.3):

  • Web-based LEND Portal (registration, consent, outcome measures)
  • Machine-learning narrative recommender
  • Narrative filtering and content warnings
  • Ability to rate, block, or bookmark narratives
  • Optional LEND eBooklet for digital inclusion (low-tech video player) All narratives used are categorised using the INCRESE-D system developed in WP2.1 and curated into the LEND Collection (WP2.2).

WORK PACKAGE 3: Feasibility Study and Long-Term Impact WP3 evaluates feasibility, acceptability, and preliminary signals of impact in preparation for a full-scale RCT.

WP3.1: Randomised Controlled Feasibility Study

Design:

  • Parallel-group RCT with 1:1 randomisation
  • Intervention (Online LEND Intervention) vs. Treatment as Usual (TAU)
  • Stratified by co-resident carer status
  • Remote computerised randomisation via Bangor Clinical Trials Unit
  • Analysts blinded to allocation Sample: n=60
  • 30 people with dementia
  • 30 carers Duration: 6-month follow-up period

Outcome Measures (all self-report via LEND Portal):

Primary outcomes include:

  • QoL-AD (PWoD only)
  • SWEMWBS (both groups)

Secondary outcomes include:

  • EID-Q, RSES, GSES, CSES, Zarit Burden, EQ-5D-5L, ICECAP-O, Adult Hope Scale, CSRI

Feasibility Outcomes:

  • Recruitment rates and retention
  • Adherence and engagement with intervention (time spent, narratives accessed)
  • Acceptability and suitability of intervention in real-world contexts
  • Data completeness and technical viability of digital data collection

WP3.2: Long-Term Impact Interviews Purpose: To evaluate longer-term influence of the LEND intervention among those who received it in WP3.1.

Sample: n=20

  • 10 people with dementia
  • 10 carers

Timing:

  • 12 months post-randomisation
  • 18 months post-randomisation

Focus:

  • Sustained changes in wellbeing, confidence, independence, and support
  • Usability, acceptability, suitability over longer durations
  • Experiences with platform features and narrative engagement
  • Identification of risks, barriers, or unintended consequences Interviews are recorded, transcribed, and linked to participants' engagement and demographic data using a pseudonymised UID system

Integrated Purpose of WP1-3

Collectively, these work packages:

  • Establish the theoretical foundation (WP1)
  • Develop a user-centred and accessible digital intervention (WP2)
  • Evaluate feasibility, acceptability, and preliminary outcomes required for a future fully powered clinical trial (WP3) This integrated, iterative design follows the MRC Framework for Developing and Evaluating Complex Interventions (2021) and aligns with NICE digital technology evidence standards.

WP4 and WP5 will be determined following the evaluation of WP1-3.

02

Conditions studied

  • Dementia
  • Neuro-Degenerative Disease
  • Alzheimer Disease
  • Caregiver Burden
  • Caregiver Burnout
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

General Inclusion Criteria (apply across WP1-WP3)

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

General Exclusion Criteria (apply across WP1-3)

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Online LEND Intervention

    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

  • No intervention
    Treatment as Usual

    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

  • BehavioralOnline LEND Intervention

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Six Months

  2. 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.

    Time frame: Baseline and Six Months

Secondary outcomes

  1. Engagement and Independence in Dementia Questionnaire (EID-Q)

    For people with dementia only. Assesses engagement in meaningful activities, independence, autonomy, and perceived capabilities in daily life.

    Time frame: Baseline and Six Months

  2. Rosenberg Self-Esteem Scale - Brief Version (RSES)

    For both people with dementia and family carers. Measure of global self-esteem and self-worth.

    Time frame: Baseline and Six Months

Other outcomes

  1. General Self-Efficacy Scale (GSES)

    For both people with dementia and family carers. Evaluates confidence in ability to cope with challenges, problem-solve, and exert control over important aspects of life.

    Time frame: Baseline and Six Months

  2. Caregiver Self-Efficacy Scale (CSES)

    For Family carers only. Assesses carers' perceived ability to manage caregiving tasks, access support, and maintain personal wellbeing.

    Time frame: Baseline and Six Months

  3. Zarit Burden Interview - Short Version (ZBI-12)

    For family carers only. Measures subjective caregiver burden, including emotional strain, role stress, and perceived overload.

    Time frame: Baseline and Six Months

  4. EQ-5D-5L

    People with dementia and carers. Assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Time frame: Baseline and Six Months

  5. ICECAP-O (ICEpop CAPability Measure for Older People)

    People with dementia only. Evaluates broader wellbeing and capability across domains including attachment, security, role, enjoyment, and control.

    Time frame: Baseline and Six Months

  6. Adult Hope Scale (AHS)

    For people with dementia and carers. Measures goal-directed thinking, including pathways (planning routes to goals) and agency (motivation to pursue goals).

    Time frame: Baseline and Six Months

  7. Client Service Receipt Inventory (CSRI)

    For people with dementia and carers. Captures service use, support needs, and associated costs from both health and social care perspectives.

    Time frame: Baseline and Six Months

06

Study locations

2 of 2 sites recruiting
  • 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
07

References and documents

Study documents

  • Study protocol · Sep 22, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Only anonymised data will be shared for the purposes of analysis and interpretation.

08

Registry details

Key details

Study ID
NCT07757178
Lead sponsor
University of Nottingham
Collaborators
Nottinghamshire Healthcare NHS Trust
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Nov 17, 2025
Primary completion
Mar 2029 (estimated)
Completion
Jul 2029 (estimated)
Last update
Aug 11, 2026

Study contacts

Linda E O'Raw, PhD
Contact
linda.o'raw@nottingham.ac.uk
07791598280
Mark Howells
Contact
mark.howells@nottshc.nhs.uk
Martin Orrell
study director · University of Nottingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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