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| Name | Class |
|---|---|
| Shaoxing Gaobu Street Community Health Service Center | UNKNOWN |
| Shaoxing Mashan Street Community Health Service Center | UNKNOWN |
| Shaoxing Doumen Street Community Health Service Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard health counseling at baseline | No Intervention | Standard health counseling at baseline | |
| Self-monitoring and personalized feedback on smartphone app | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-monitoring and personalized feedback on smartphone app | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Primary Outcome | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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） | Short-term Secondary Outcome | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affilated Hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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|
Short-term Secondary Outcome |
| 1 year |
| Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) | Short-term Secondary Outcome | 1 year |
| Dementia and cerebrovascular events incidence | Short-term Secondary Outcome | 1 year |
| Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI | Short-term Secondary Outcome | 1 year |
| Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI | Short-term Secondary Outcome | 1 year |
| Dementia and cerebrovascular events incidence | Long-term Secondary Outcome | 5 years |
| Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome) | Short-term Secondary Outcome | 1 year |
| Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome) | Short-term Secondary Outcome | 1 year |
| Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome) | Short-term Secondary Outcome | 1 year |
| 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 | Long-term Secondary Outcome | 5 years |
| 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) | Long-term Secondary Outcome | 5 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) | Long-term Secondary Outcome | 5 years |
| Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI | Long-term Secondary Outcome | 5 years |
| Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI | Long-term Secondary Outcome | 5 years |
| Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome) | Long-term Secondary Outcome | 5 years |
| Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome) | Long-term Secondary Outcome | 5 years |
| Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome) | Long-term Secondary Outcome | 5 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 | Long-term Secondary Outcome | 2 years |
| Dementia and cerebrovascular events incidence | Long-term Secondary Outcome | 2 years |
| 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) | Long-term Secondary 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) | Long-term Secondary Outcome | 2 years |
| Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI | Long-term Secondary Outcome | 2 years |
| Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI | Long-term Secondary Outcome | 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) | Long-term Secondary 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) | Long-term Secondary Outcome | 2 years |
| Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome) | Long-term Secondary Outcome | 2 years |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D020521 | Stroke |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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