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

Summary

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.

Conditions

• Cognitive Impairment
• Stroke
• Dementia

Interventions

BEHAVIORAL

Self-monitoring and personalized feedback on smartphone app

1. 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; 2. 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; 3. 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; 4. Patients will complete cognitive training games every week on app; 5. Medical staff will send health information on app

Sponsors & Collaborators

• Shaoxing Gaobu Street Community Health Service Center

  collaborator UNKNOWN

• Shaoxing Mashan Street Community Health Service Center

  collaborator UNKNOWN

• Shaoxing Doumen Street Community Health Service Center

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-21

Primary Completion

2021-08-05

Completion

2025-05-31

Countries

• China

Study Locations