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Completed

NCT Number: NCT04465812

The Impact of a Smartphone-based Personalized Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA

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.

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Key information

Conditions

Cognitive Impairment Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Stroke Vascular Diseases

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Self-monitoring and personalized feedback on smartphone app

Behavioral
  • 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

Primary outcomes

  1. 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

    Primary Outcome

Secondary outcomes

  1. 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）

    Time frame: 1year

    Short-term Secondary Outcome

  2. 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

    Short-term Secondary Outcome

  3. 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

    Short-term Secondary Outcome

  4. Dementia and cerebrovascular events incidence

    Time frame: 1 year

    Short-term Secondary Outcome

  5. Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI

    Time frame: 1 year

    Short-term Secondary Outcome

  6. Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI

    Time frame: 1 year

    Short-term Secondary Outcome

  7. Dementia and cerebrovascular events incidence

    Time frame: 5 years

    Long-term Secondary Outcome

  8. 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

    Short-term Secondary Outcome

  9. 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

    Short-term Secondary Outcome

  10. 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

    Short-term Secondary Outcome

  11. 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

    Long-term Secondary Outcome

  12. 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

    Long-term Secondary Outcome

  13. 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

    Long-term Secondary Outcome

  14. Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI

    Time frame: 5 years

    Long-term Secondary Outcome

  15. Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI

    Time frame: 5 years

    Long-term Secondary Outcome

  16. 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

    Long-term Secondary Outcome

  17. 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

    Long-term Secondary Outcome

  18. 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

    Long-term Secondary Outcome

  19. 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: 2 years

    Long-term Secondary Outcome

  20. Dementia and cerebrovascular events incidence

    Time frame: 2 years

    Long-term Secondary Outcome

  21. 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: 2 years

    Long-term Secondary Outcome

  22. 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: 2 years

    Long-term Secondary Outcome

  23. Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI

    Time frame: 2 years

    Long-term Secondary Outcome

  24. Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI

    Time frame: 2 years

    Long-term Secondary Outcome

  25. 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: 2 years

    Long-term Secondary Outcome

  26. 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: 2 years

    Long-term Secondary Outcome

  27. Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)

    Time frame: 2 years

    Long-term Secondary Outcome

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Shaoxing Doumen Street Community Health Service Center
  • Shaoxing Gaobu Street Community Health Service Center
  • Shaoxing Mashan Street Community Health Service Center

Registry information

Official study title

The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Jul 10, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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