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

NCT07098143 | Not Yet Recruiting

• 1 other identifier: [2024]444-003-1-2
• Study Type: interventional
• Target: 5,092
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 1-year recurrence rate of stroke

  Intervention at the 1-year

Secondary Outcomes (18)

• 3-month, 6-month, 9-month recurrence rate of stroke

  Intervention at 3-month, 6-month, 9-month

• Health literacy scale score

  Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

• System usability scale score

  Intervention at 3-month, 6-month, 9-month and 1-year

• Blood pressure

  Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

• Electrocardiogram (ECG) parameters

  Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

Other Outcomes (1)

• Incidence of adverse cerebrovascular events

  Intervention at the 1-year

Study Arms (2)

Risk factor management group

EXPERIMENTAL

Other: Risk factor management

Routine education

NO INTERVENTION

Interventions

Risk factor management OTHER

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

Risk factor management group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Junwei Hao

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Junwei Hao

CONTACT

010-83198277; haojunwei@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share