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

The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple 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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cognitive Impairment; Dementia
• Intervention / Treatment: Behavioral: Self-monitoring and personalized feedback on smartphone app

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China, 310009
      • Second Affilated Hospital of Zhejiang University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard health counseling at baseline
Experimental: Self-monitoring and personalized feedback on smartphone app; 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	Behavioral: Self-monitoring and personalized feedback on smartphone app; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Short-term Primary Outcome	1 year
Dementia and cerebrovascular events incidence	Long-term Primary Outcome	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI	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
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)	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
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
Dementia and cerebrovascular events incidence	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
Dementia and cerebrovascular events incidence	Long-term Secondary Outcome	3 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	3 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	3 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	3 years
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI	Long-term Secondary Outcome	3 years
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI	Long-term Secondary Outcome	3 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	3 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	3 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	3 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Shaoxing Gaobu Street Community Health Service Center; Shaoxing Mashan Street Community Health Service Center; Shaoxing Doumen Street Community Health Service Center

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2020
• Primary Completion (Actual): August 5, 2021
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: CIRCLE-CHINA II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No