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

NCT04465812 | Completed DMC

• 1 other identifier: CIRCLE-CHINA II
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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

  Primary Outcome

  1 year

Secondary Outcomes (27)

• 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）

  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)

  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)

  1 year

• Dementia and cerebrovascular events incidence

  1 year

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

  1 year

Study Arms (2)

Standard health counseling at baseline

NO INTERVENTION

Standard health counseling at baseline

Self-monitoring and personalized feedback on smartphone app

EXPERIMENTAL

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

Behavioral: Self-monitoring and personalized feedback on smartphone app

Interventions

Self-monitoring and personalized feedback on smartphone app BEHAVIORAL

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

Self-monitoring and personalized feedback on smartphone app

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 10, 2020
• Study Start: July 21, 2020
• Primary Completion: August 5, 2021
• Study Completion: May 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2024-01

Locations

CN (1)