Improving the Quality of Life for People Living With Dementia and Carers: The Design and Development of a Dementia Specific Online Narrative-Based Intervention With a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of Life (QoL-AD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •(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
研究组 & 干预措施
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.
干预措施: Online LEND Intervention (Behavioral)
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.
结局指标
主要结局
Quality of Life (QoL-AD)
时间窗: Baseline and Six Months
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.
Mental Wellbeing (SWEMWBS)
时间窗: Baseline and Six Months
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.
次要结局
- Engagement and Independence in Dementia Questionnaire (EID-Q)(Baseline and Six Months)
- Rosenberg Self-Esteem Scale - Brief Version (RSES)(Baseline and Six Months)