Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults - the LETHE-AT Randomised-controlled, Multicentre Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Operational feasibility: retention rate
研究概览
简要总结
The goal of this clinical trial is to learn whether a hybrid multidomain lifestyle program can prevent cognitive decline and reduce dementia risk in community-dwelling adults in mid- to late life who are at increased risk of Alzheimer´s disease or related dementias but do not yet have significant cognitive impairment.
The main question the study aims to answer are:
- Whether the structured hybrid multidomain lifestyle intervention is feasible (e.g., adherence and retention rate), and how well the digital components are accepted and implemented in the intervention group.
- Does the intervention reduces the overall burden of modifiable dementia risk factors and improves global cognitive performance compared with usual care.
Researchers will compare participants assigned to the tailored hybrid multidomain lifestyle intervention group with those in a self-guided multimodal lifestyle advice group.
Participants assigned to the intervention group will receive a plan adjusted to their individual dementia risk profile. A physician trained in motivational interviewing will review their progress continuously.
The self-guided multimodal lifestyle advice group will receive rigid but comprehensible lifestyle health advice with reduced access to digital support tools.
Participants will:
- Complete an initial risk assessment that uses machine-learning triage to identify and prioritize their most important modifiable dementia risk factors.
- Receive personalized recommendations for gradual lifestyle change, including physical activity, nutrition, cognitive training, other dementia risk-factor management (e.g. hearing impairment), stress & sleep management, and social activities.
- Use a smartphone and smartwatch to passively collect digital biomarkers and to complete questionnaires at regular intervals, so that physicians trained in motivational interviewing can adapt goals through shared decision making.
- Use a study app as the central access point for the program, including educational content, progress tracking, and gamified challenges with social comparison and incentives.
详细描述
LETHE AT is an 18 month multicentre randomized controlled trial in Austria that evaluates a tailored hybrid multidomain lifestyle intervention programme in older adults with multiple dementia risk factors and is conducted at the Medical Universities of Vienna, Innsbruck, and Graz.
Previous multidomain lifestyle trials have shown that structured interventions targeting modifiable risk factors can attenuate cognitive decline and reduce dementia risk. These programme have used different delivery formats, including intensive face to face interventions (FINGER), fully digital approaches (Maintain Your Brain), and hybrid models (SMART and LETHE EU). LETHE-AT builds on this foundation by combining refined risk profiling and motivational interviewing (MI) with a centrally organized online and telephone prescreening process. This approach identifies cognitively unimpaired adults with a high burden of dementia risk factors and reduces avoidable on-site screening failures and participant disappointment.
Following the prescreening, comprehensive on-site screening is conducted at three Austrian memory clinics to enroll 300 participants. Eligibility is determined using predefined inclusion and exclusion criteria, including age 55-75 years, preserved cognition, subjective cognitive decline or a first-degree family history of dementia, the presence of at least three of 14 established modifiable dementia risk factors (e.g. hearing impairment, elevated LDL cholesterol), and sufficient motivation for lifestyle change as evaluated by physicians trained in MI.
Eligible participants are invited for a baseline visit, where dementia risk is quantified using LIBRA2 and ANU-ADRI, and a harmonized neuropsychological and functional assessment battery is administered by trained neuropsychologists.
The study population is then stratified by sex, age and study site and randomly assigned in a 1:1 ratio to the tailored hybrid multidomain lifestyle intervention group or to the self-guided multimodal lifestyle advice group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will not be actively told to what group they have been assigned (intervention or control). Outcome assessors will be blinded to the group allocation.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 55 and 75 years at the time of screening.
- •Fluency in German.
- •All participants must be able and willing to provide written informed consent form (ICF) prior to any study-related procedures.
- •Ownership of a compatible Android smartphone, or willingness and capability to use a study-provided Android smartphone for the duration of the study.
- •Subjective cognitive decline and/or a positive first-degree family history of dementia.
- •Willingness to make meaningful changes in at least three of six lifestyle domains: dietary counselling, physical activity, cognitive training, vascular risk management, social interaction, and sleep and relaxation.
- •Cognitive performance at or slightly below age expectations, defined as an m-TICS (modified Telephone Interview for Cognitive Status) score ≥ 37/50, and a Montreal Cognitive Assessment (MoCA) ≥ 26/30.
排除标准
- •Diagnosed or suspected dementia or substantial cognitive impairment, defined as an m-TICS score ≤ 36 or MoCA < 26, or current or previous use of Alzheimer´s disease or other dementia medication.
- •Significant neurological disease, including but not limited to Parkinson´s disease, Huntington´s disease, normal pressure hydrocephalus, brain tumour, progressive supranuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis, or a history of significant head trauma with persistent neurological sequelae or known structural brain abnormalities.
- •Diminished decision-making capacity, inability to provide informed consent, inability to complete study assessments, or any condition preventing effective cooperation, as determined by clinical judgement.
- •Severe impairment of vision, hearing, or communication abilities that would preclude participation in study procedure.
- •Any medical or psychiatric condition affecting safe engagement, including but not limited to active malignancy, major depressive disorder, symptomatic cardiovascular disease, or revascularisation procedures within the past year.
- •Current participation in another interventional trial, unless the study team determines this does not interfere with participation in the LETHE-AT.
研究组 & 干预措施
A self-guided multimodal lifestyle advice group
Participants in the control arm receive a self-guided lifestyle advice programme via the LETHE-AT app and smartwatch, with standardized information across all lifestyle domains but without motivational interviewing, structured coaching or algorithm-based personalization.
干预措施: Self-guided multimodal lifestyle advice group (Behavioral)
A tailored hybrid multidomain lifestyle intervention group
Participants in the intervention arm receive an MI-guided hybrid multidomain lifestyle intervention that integrates AI-based risk profiling, personalized goal setting and structured telehealth coaching with app- and smartwatch-supported self-management across six lifestyle domains.
干预措施: A tailored hybrid multidomain lifestyle intervention group (Behavioral)
结局指标
主要结局
Operational feasibility: retention rate
时间窗: Baseline to 18 months
Proportion of all randomized participants who complete the Month 18 assessment in each trial arm (percentage of all randomized participants; higher percentage = better retention).
Operational feasibility: adherence to the structured hybrid lifestyle intervention
时间窗: Continuously assessed over 18 months
Composite adherence score combining attendance at workshops and telehealth sessions, engagement with the LETHE-AT app (logins and completed modules), and proportion of days with successful smartwatch data uploads (higher values = better adherence).
次要结局
- Change in health-related quality of life (SF-36)(Baseline to 18 months)
- Change in health literacy (HLS-EU-Q16)(Baseline to 18 months)
- User acceptance of the digital solution (SUS)(2 months past enrollment to 18 months)
- Change in perceived stress (PSS-14)(Baseline, Month 9, 18 months.)
- Change in insomnia symptoms (ISI)(Baseline, Month 9, 18 months)
研究者
Elisabeth Stögmann
Physician Investigator
Medical University of Vienna