<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04465812</url>
  </required_header>
  <id_info>
    <org_study_id>CIRCLE-CHINA II</org_study_id>
    <nct_id>NCT04465812</nct_id>
  </id_info>
  <brief_title>The Impact of a Smartphone-based Personalized Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA</brief_title>
  <official_title>The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shaoxing Gaobu Street Community Health Service Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaoxing Mashan Street Community Health Service Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaoxing Doumen Street Community Health Service Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This smartphone-based personalized multiple intervention study aims to prevent cognitive&#xD;
      impairment and reduce dementia and cerebrovascular events in 45-74 year old persons with high&#xD;
      risk of stroke in China. The investigators plan to monitor and manage participants'&#xD;
      behavioral and health (vascular risk factors control, sleep quality, mental health and&#xD;
      cognitive training) based on self-monitoring and personalized feedback via smartphone app.&#xD;
      The short-term primary outcome is 1-year change in global cognitive score measured by a&#xD;
      modified National Institute of Neurological Disorders and Stroke and Canadian Stroke&#xD;
      Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention&#xD;
      based on self-monitoring and personalized feedback will prevent cognitive decline by the&#xD;
      initial 1-year intervention. The long-term primary outcome is the development of dementia and&#xD;
      cerebrovascular events during a total of 5 years' follow-up. The investigators hypothesize&#xD;
      that the smartphone-based personalized multiple intervention may reduce the 5-year risk of&#xD;
      dementia and cerebrovascular events, mainly through the improvement in vascular risk factors&#xD;
      control, sleep quality, mental health and cognitive training activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with ≥ 3 stroke risk factors (including hypertension, dyslipidemia, diabetes, atrial&#xD;
      fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack&#xD;
      of exercise, family history of stroke), or with transient ischemic attack, are regarded as&#xD;
      patients with high risk of stroke. Studies have indicated that these stroke risk factors&#xD;
      might be associated with an increased risk of cerebral small vessel disease (CSVD) progress,&#xD;
      glymphatic dysfunction, cognitive decline, dementia, and cerebrovascular events. However,&#xD;
      prevention in these patients is largely unknown and the management of these patients is a&#xD;
      very troublesome issue. Previous study has demonstrated that interventions in the feedback&#xD;
      and monitoring method could improve exercise adherence in older people compared with other&#xD;
      methods including comparison of behavior, social support, natural consequences, identity and&#xD;
      goals and planning. Therefore, the investigators plan to monitor and manage vascular risk&#xD;
      factors control, sleep quality, mental health and cognitive training based on self-monitoring&#xD;
      and personalized feedback on a smartphone app in patients with high risk of stroke. The&#xD;
      investigators hypothesize that the intervention based on self-monitoring and personalized&#xD;
      feedback will reduce cognitive impairment, glymphatic dysfunction, CSVD progress, depressive&#xD;
      symptoms, anxious symptoms, improve sleep quality, and reduce dementia and cerebrovascular&#xD;
      events incidence in the study group compared to the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 4, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Primary Outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dementia and cerebrovascular events incidence</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Primary Outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dementia and cerebrovascular events incidence</measure>
    <time_frame>1 year</time_frame>
    <description>Short-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dementia and cerebrovascular events incidence</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)</measure>
    <time_frame>3 years</time_frame>
    <description>Long-term Secondary Outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">824</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Stroke</condition>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Standard health counseling at baseline</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard health counseling at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-monitoring and personalized feedback on smartphone app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit;&#xD;
Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index &gt; 15 to assess detail clinical status and recommend outpatient visit if necessary;&#xD;
Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS&gt;49 or SDS&gt;52 to assess detail clinical status and recommend outpatient visit if necessary;&#xD;
Patients will complete cognitive training games every week on app;&#xD;
Medical staff will send health information on app</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-monitoring and personalized feedback on smartphone app</intervention_name>
    <description>Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit;&#xD;
Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index &gt; 15 to assess detail clinical status and recommend outpatient visit if necessary;&#xD;
Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS&gt;49 or SDS&gt;52 to assess detail clinical status and recommend outpatient visit if necessary;&#xD;
Patients will complete cognitive training games every week on app;&#xD;
Medical staff will send health information on app</description>
    <arm_group_label>Self-monitoring and personalized feedback on smartphone app</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 45-74 years&#xD;
&#xD;
          -  high risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension,&#xD;
             dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking&#xD;
             history, obvious overweight or obesity, lack of exercise, family history of stroke, or&#xD;
             with transient ischemic attack)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previously diagnosed dementia&#xD;
&#xD;
          -  previously diagnosed stroke (both cerebral infarction and hemorrhage)&#xD;
&#xD;
          -  suspected dementia after clinical assessment by study physician at screening visit&#xD;
&#xD;
          -  disorders affecting safe engagement in the intervention (eg, malignant disease, major&#xD;
             depression, symptomatic cardiovascular disease, revascularisation within 1 year&#xD;
             previously)&#xD;
&#xD;
          -  severe loss of vision, hearing, or communicative ability;&#xD;
&#xD;
          -  disorders preventing cooperation as judged by the study physician&#xD;
&#xD;
          -  coincident participation in another intervention trial&#xD;
&#xD;
          -  any MRI contraindications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Second Affilated Hospital of Zhejiang University, School of Medicine</name>
      <address>
        <city>HangZhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Min Lou, PhD, MD</last_name>
      <phone>13958007213</phone>
      <email>lm99@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>Min Lou</investigator_full_name>
    <investigator_title>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04465812
org study id: CIRCLE-CHINA II
nct id: NCT04465812
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: 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
time frame: 1 year
description: Short-term Primary Outcome
measure: Dementia and cerebrovascular events incidence
time frame: 5 years
description: Long-term Primary Outcome
measure: Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
time frame: 1 year
description: Short-term Secondary Outcome
measure: Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
time frame: 1 year
description: Short-term Secondary Outcome
measure: 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)
time frame: 1 year
description: Short-term Secondary Outcome
measure: Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
time frame: 1 year
description: Short-term Secondary Outcome
measure: Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
time frame: 1 year
description: Short-term Secondary Outcome
measure: Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
time frame: 1 year
description: Short-term Secondary Outcome
measure: Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
time frame: 1 year
description: Short-term Secondary Outcome
measure: Dementia and cerebrovascular events incidence
time frame: 1 year
description: Short-term Secondary Outcome
measure: 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
time frame: 5 years
description: Long-term Secondary Outcome
measure: 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)
time frame: 5 years
description: Long-term Secondary Outcome
measure: Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
time frame: 5 years
description: Long-term Secondary Outcome
measure: Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
time frame: 5 years
description: Long-term Secondary Outcome
measure: Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
time frame: 5 years
description: Long-term Secondary Outcome
measure: Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
time frame: 5 years
description: Long-term Secondary Outcome
measure: Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
time frame: 5 years
description: Long-term Secondary Outcome
measure: Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
time frame: 5 years
description: Long-term Secondary Outcome
measure: Dementia and cerebrovascular events incidence
time frame: 3 years
description: Long-term Secondary Outcome
measure: 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
time frame: 3 years
description: Long-term Secondary Outcome
measure: 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)
time frame: 3 years
description: Long-term Secondary Outcome
measure: Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
time frame: 3 years
description: Long-term Secondary Outcome
measure: Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
time frame: 3 years
description: Long-term Secondary Outcome
measure: Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
time frame: 3 years
description: Long-term Secondary Outcome
measure: Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
time frame: 3 years
description: Long-term Secondary Outcome
measure: Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
time frame: 3 years
description: Long-term Secondary Outcome
measure: Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
time frame: 3 years
description: Long-term Secondary Outcome
arm group label: Standard health counseling at baseline
arm group type: No Intervention
description: Standard health counseling at baseline
arm group label: Self-monitoring and personalized feedback on smartphone app
arm group type: Experimental
description: Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit;
Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary;
Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary;
Patients will complete cognitive training games every week on app;
Medical staff will send health information on app
intervention type: Behavioral
intervention name: Self-monitoring and personalized feedback on smartphone app
description: Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit;
Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary;
Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary;
Patients will complete cognitive training games every week on app;
Medical staff will send health information on app
arm group label: Self-monitoring and personalized feedback on smartphone app
criteria: 
gender: All
minimum age: 45 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: Min Lou
investigator title: Second Affiliated Hospital, School of Medicine, Zhejiang University
mesh term: Dementia
mesh term: Cognitive Dysfunction
sharing ipd: Undecided