An Application Provides Personalized Suggestions Based on Secondary Prevention Risk Factors to Stroke Patients

NCT ID: NCT07098143

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5092 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-08-31

Brief Summary

This study applied an application that provides personalized suggestions and explore the effect of this actual intervention on reducing the risk of stroke recurrence

Detailed Description

This study applied an application that provides personalized suggestions based on participant's own secondary prevention risk factors status to stroke patients, enabling them to promptly take protective measures. And explore the effect of this actual intervention on reducing the risk of stroke recurrence after one year, as well as changes in other health-related indicators.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Risk factor management group

Group Type: EXPERIMENTAL

Risk factor management

Intervention Type: OTHER

Receive individualized prevention risk factor management information for stroke through the application

Routine education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Risk factor management

Receive individualized prevention risk factor management information for stroke through the application

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 40 to 80, with no gender restrictions;

• Acute ischemic stroke inpatients within 2 weeks of onset, where the onset time is the time when stroke symptoms appear or the last known normal time of the patient (when it is an onset during sleep or the symptom onset time cannot be accurately obtained due to aphasia, impaired consciousness, etc.);

• Confirmed diagnosis of ischemic stroke by CT or MRI of the brain within 2 weeks after symptom onset; ④ Local residents (residing for ≥6 months); ⑤ Patients who voluntarily participate in the study, have high compliance, and can sign the informed consent form;

• Patients who own a smartphone or other smart devices.

Exclusion Criteria

• Patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases;

• Known pregnant or lactating women, or those who tested positive on a pregnancy test before cluster randomization;

• Patients with other conditions that may affect participation in the trial (e.g., refractory hypertension, severe aphasia, etc.);

• Patients undergoing psychiatric/psychological treatment that may contaminate the results; ⑤ Patients with a life expectancy of less than one year (e.g., coexisting malignant tumors, severe cardiopulmonary diseases, etc.);

• Patients already participating in other interventional clinical studies that may influence the outcome assessment; ⑦ Patients for whom the investigator deems unsuitable for participation in this study or who may pose significant risks to the patients (e.g., cognitive impairment preventing understanding and/or compliance with the study procedures and/or follow-up).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junwei Hao

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Central Contacts

Junwei Hao

Role: CONTACT

haojunwei@vip.163.com

010-83198277

Other Identifiers

[2024]444-003-1-2

Identifier Type: -

Identifier Source: org_study_id