Secondary Prevention of Dementia in Memory Clinics: Implementation and (cost-)effectiveness of an Integrated Lifestyle Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Lifestyle for BRAin Health (LIBRA) score 2
研究概览
简要总结
Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is a multi-center, randomized, controlled, lifestyle intervention trial among 300 older adults (≥50 years) with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) at risk of dementia. Participants are randomized in a 1:1 ratio to Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.
详细描述
Rationale: Dementia prevention through lifestyle has much potential but is not implemented in routine care. Patients referred to memory clinics, such as people with mild cognitive impairment (MCI) and subjective cognitive disorder (SCD), are at high risk for dementia and tend to have a worse health and lifestyle profile. While they might greatly benefit from lifestyle changes, there is no offer to help them make those changes.
Objective: The primary objectives are to examine both the (cost-)effectiveness of an innovative 1-year lifestyle intervention on lifestyle change measured by the validated Lifestyle for Brain Health Score (LIBRA) in older adults with SCD or MCI; and to identify possibilities, barriers, and facilitators for sustainable implementation of the lifestyle intervention.
Study design: Multicenter, randomized controlled trial comparing a lifestyle intervention with care as usual and general health advice.
Study population: 300 older adults (≥50 years) with SCD and MCI at risk of dementia.
Intervention: Participants are randomly allocated on a 1:1 ratio to participate either in Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.
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)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥50 years of age at pre-screening;
- •Having a diagnosis of SCD or MCI;
- •Presence of ≥ 2 modifiable risk factors for dementia.
排除标准
- •Having a diagnosis of dementia;
- •Insufficient understanding of the Dutch language;
- •Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), other conditions preventing co-operation as judged by the local study nurse or consulted physician at the local study site;
- •Participation in any other research intervention trial at time of pre-screening and throughout the study period.
结局指标
主要结局
Lifestyle for BRAin Health (LIBRA) score 2
时间窗: 1 year
1-year change in the Lifestyle for BRAin Health (LIBRA) score 2. This is a weighted score of fifteen lifestyle-related risk factors that are proven to be associated with increased dementia risk. Higher score means a greater risk for dementia. Scored from -6.1 to 25.8 (absolute weight).
次要结局
- 15-Word Verbal Learning Test(1 year)
- Digit Symbol Substitution Test (DSST)(1 year)
- Wechsler Adult Intelligent Scale (WAIS) digit span(1 year)
- Trail Making Test(1 year)
- Semantic Fluency Test(1 year)
- EuroQol-5D-5L(1 year)
- ICEpop CAPability measure for Older people (ICECAP-O)(1 year)
- Health locus of Control Scale(1 year)
- General Self-Efficacy scale(1 year)
- Pearlin Mastery Scale(1 year)
- Cholesterol(1 year)
- Hemoglobin A1c(1 year)
- Estimated glomerular filtration rate (eGFR)(1 year)
- Body mass Index (BMI)(1 year)
- Blood pressure(1 year)
- Medical history(1 year)
- Amsterdam-Instrumental Activities Daily Living (ADL) Questionnaire(1 year)
- Mediterranean Diet Adherence Screener (MEDAS)(1 year)
- Investigation into Cancer and Nutrition (EPIC) physical activity questionnaire(1 year)
- Cognitive and Leisure Activities Scale(1 year)
- Perceived Stress Scale(1 year)
- Patient Health Questionnaire (PHQ)-9(1 year)
- Groningen Sleep Quality Scale (GSKS)(1 year)
- 6-item Lubben social network Scale(1 year)
- De Jong Gierveld 6-item Scale(1 year)
- Knowledge on dementia risk questionnaire(1 year)
- Smoking(1 year)
- Alcohol intake(1 year)
- Medical Consumption Questionnaire (iMCQ)(1 year)
- Productivity Costs Questionnaire (iPCQ)(1 year)
- Adherence(1 year)