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

N/ANot Yet RecruitingNCT07098143

Xuanwu Hospital, Beijing5,092 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

5,092

Conditions

Acute Ischemic Stroke

Interventions

Risk factor managementOTHER

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

1-year recurrence rate of stroke

Time frame: Intervention at the 1-year

Secondary Outcomes

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

Time frame: Intervention at 3-month, 6-month, 9-month

Health literacy scale score

It is used to assess patients' understanding about secondary prevention risk factors. The lower the score, the less they understand or are concerned about it

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

System usability scale score

It is used to understand the subjects' satisfaction and usability evaluation of the intelligent program. The higher the score, the better the evaluation

Time frame: Intervention at 3-month, 6-month, 9-month and 1-year

Blood pressure

Systolic and diastolic blood pressure will be measured using a standard automated sphygmomanometer

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

Electrocardiogram (ECG) parameters

Electrocardiogram (ECG) will be performed to assess cardiac electrical activity. Specific parameters will be analyzed, such as heart rate (beats per minute (bpm)), QT interval (milliseconds (ms)), PR interval (milliseconds (ms)), QRS duration (milliseconds (ms))

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

Fasting blood glucose

Fasting plasma glucose levels will be measured to assess glycemic control

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

Central Contacts

Junwei Hao

CONTACT

010-83198277 haojunwei@vip.163.com

Data from ClinicalTrials.gov

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