The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
研究概览
简要总结
This smartphone-based personalized multiple intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 year old persons with high risk of stroke in China. The investigators plan to monitor and manage participants' behavioral and health (vascular risk factors control, sleep quality, mental health and cognitive training) based on self-monitoring and personalized feedback via smartphone app. The short-term primary outcome is 1-year change in global cognitive score measured by a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will prevent cognitive decline by the initial 1-year intervention. The long-term primary outcome is the development of dementia and cerebrovascular events during a total of 5 years' follow-up. The investigators hypothesize that the smartphone-based personalized multiple intervention may reduce the 5-year risk of dementia and cerebrovascular events, mainly through the improvement in vascular risk factors control, sleep quality, mental health and cognitive training activities.
详细描述
Patients with ≥ 3 stroke risk factors (including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke), or with transient ischemic attack, are regarded as patients with high risk of stroke. Studies have indicated that these stroke risk factors might be associated with an increased risk of cerebral small vessel disease (CSVD) progress, glymphatic dysfunction, cognitive decline, dementia, and cerebrovascular events. However, prevention in these patients is largely unknown and the management of these patients is a very troublesome issue. Previous study has demonstrated that interventions in the feedback and monitoring method could improve exercise adherence in older people compared with other methods including comparison of behavior, social support, natural consequences, identity and goals and planning. Therefore, the investigators plan to monitor and manage vascular risk factors control, sleep quality, mental health and cognitive training based on self-monitoring and personalized feedback on a smartphone app in patients with high risk of stroke. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will reduce cognitive impairment, glymphatic dysfunction, CSVD progress, depressive symptoms, anxious symptoms, improve sleep quality, and reduce dementia and cerebrovascular events incidence in the study group compared to the control 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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 45-74 years
- •high risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
排除标准
- •previously diagnosed dementia
- •previously diagnosed stroke (both cerebral infarction and hemorrhage)
- •suspected dementia after clinical assessment by study physician at screening visit
- •disorders affecting safe engagement in the intervention (eg, malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously)
- •severe loss of vision, hearing, or communicative ability;
- •disorders preventing cooperation as judged by the study physician
- •coincident participation in another intervention trial
- •any MRI contraindications
结局指标
主要结局
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
时间窗: 1 year
Primary Outcome
次要结局
- The change of cognitive score for each domain of NINDS-CSN battery from baseline to 12-month（attention, executive, Language, visuomotor speed, visuospatial function, memory）(1year)
- Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)(2 years)
- Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)(2 years)
- Dementia and cerebrovascular events incidence(2 years)
- Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI(2 years)
- Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI(2 years)
- Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)(2 years)
- Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)(2 years)
- Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)(2 years)
- Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol(2 years)
研究者
Min Lou
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University