Implementation of a Brain Health Service for Personalized Stratification and Prevention of Dementia Risk: The B-HEALTH Project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feasibility of the multimodal intervention
研究概览
简要总结
This study evaluates the feasibility of implementing a Brain Health Service (BHS) to assess and reduce dementia risk in individuals with Subjective Cognitive Decline (SCD). A total of 120 participants will be recruited from the Cognitive Disorders Unit at Hospital del Mar and randomly assigned to either a personalized intervention group or a control group receiving general prevention advice.
The study will assess individual biological and lifestyle-related risk factors for dementia and use validated tools to estimate each participant's risk profile. Participants in the intervention group will be offered a structured dementia risk communication and counseling process, with the option to receive or decline their individual risk estimate.
The intervention consists of a 6-month multimodal program combining digital and in-person strategies tailored to each participant's risk level. These strategies include personalized recommendations to improve lifestyle factors such as diet, physical activity, sleep, social engagement, and cognitive stimulation.
The main objectives are to evaluate the feasibility of delivering this type of service, including recruitment, adherence, and retention; to assess the psychological impact of communicating dementia risk; and to examine changes in lifestyle behaviors and cognitive outcomes over time compared with a control group.
This study addresses the need for early, personalized prevention strategies for individuals with SCD and may inform broader implementation of preventive BHS.
详细描述
The scientific literature highlights the potential of dementia prevention, with studies showing decreasing incidence rates in developed countries and clinical trials demonstrating the benefits of multimodal lifestyle interventions. However, translating this evidence into clinical practice requires further scientific validation.
Subjective Cognitive Decline (SCD) refers to individuals who report cognitive complaints despite normal performance on standardized cognitive tests. This population is increasingly represented in memory clinics, accounting for approximately 20-30% of consultations in some European centers. Individuals with SCD have an increased risk of developing mild cognitive impairment and dementia compared with those without cognitive complaints, and SCD may represent an early clinical manifestation of neurodegenerative disease. However, current clinical pathways are primarily oriented toward diagnosis and management of established impairment, and individuals with SCD are often discharged without access to personalized risk assessment or prevention strategies.
Brain Health Services (BHS) have been proposed as a new clinical model to address this gap. These services aim to provide comprehensive dementia risk assessment, individualized risk communication, and tailored prevention strategies. Core components include the evaluation of modifiable and biological risk factors, the use of validated algorithms for risk stratification, structured and ethically sound risk communication, and personalized interventions targeting multiple domains of brain health.
The B-HEALTH project is a proof-of-concept longitudinal study designed to evaluate the feasibility and preliminary impact of implementing a Brain Health Service in a real-world clinical setting. A total of 120 participants with SCD will be recruited from the Cognitive Disorders Unit at Hospital del Mar and randomly assigned to either an intervention group or a control group receiving general dementia prevention advice.
Participants will undergo a comprehensive risk assessment integrating clinical, lifestyle, and biological information. Individual dementia risk profiles will be generated using validated risk scores (e.g., LIBRA index) and blood-based markers of Alzheimer's Disease (AD) pathology (ptau-217). Participants in the intervention group will be offered a structured Dementia Risk Communication and Counseling process and may choose whether or not to receive their individualized risk estimate.
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
- Single (Outcomes Assessor)
盲法说明
Nurses, neuropsychologysts and imaging experts performing the study visits will be blinded.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 55 to 85 with subjective cognitive complaints and normal screening test performance at the hospital.
- •Participants must have a minimal educational level for a neuropsychological assessment and a minimal digital literacy for the usage of smartphones, computers and Internet.
排除标准
- •Objective cognitive impairment.
- •Clinically relevant neurological disorders.
- •Major psychiatric disorders.
- •History of drug/alcohol abuse.
- •Unstable medical conditions that could fully explain cognitive complaints, as determined by the investigator.
研究组 & 干预措施
Control
Participants in the control arm will receive general recommendations on dementia risk reduction at the beginning of the study, reflecting standard preventive advice.
They will have access to a mobile application providing information on dementia risk factors; however, the application will not include personalized feedback or interactive intervention components.
Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep.
干预措施: Lifestyle Recommendations and Counseling (Behavioral)
Personalized intervention
Participants in the experimental arm will receive a 6-month personalized, multimodal intervention tailored to their individual dementia risk profile.
The intervention includes components targeting key domains of brain health, including nutrition, physical activity, cognitive training, and psychoeducation, with the intensity and combination of components adapted according to risk level.
Participants will have access to a mobile application providing personalized feedback on lifestyle behaviors and interactive support to promote adherence to the intervention.
Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep.
干预措施: Multimodal Lifestyle Intervention (Behavioral)
结局指标
主要结局
Feasibility of the multimodal intervention
时间窗: 6 months
Feasibility will be assessed using recruitment, adherence, and retention rates: 1. Recruitment rate: proportion of participants randomized among those eligible and invited to participate. A rate ≥50% will be considered successful. 2. Adherence: defined as completion of at least 50% of intervention components, including ecological momentary assessments (EMAs), online questionnaires, in-person activities, and cognitive training sessions. Participants meeting this threshold will be classified as adherent. 3. Retention rate: proportion of participants who complete the 6-month intervention period. A dropout rate \<20% will be considered acceptable. Reasons for dropout will be recorded.
次要结局
- Feasibility of dementia risk communication and counseling(6 months)
- Psychological impact of risk communication: post-traumatic stress symptoms(6 months)
- Psychological impact of risk communication: anxiety(6 months)
- Psychological impact of risk communication: depressive symptoms(6 months)
- Psychological impact of risk communication: situational anxiety(6 months)
- Change in lifestyle-related dementia risk (LIBRA index)(Baseline to 6 months)
- Change in cognitive performance(Baseline to 6 months)