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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk factor management group | Experimental |
| |
| Routine education | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk factor management | Other | Receive individualized prevention risk factor management information for stroke through the application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year recurrence rate of stroke | Intervention at the 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month, 6-month, 9-month recurrence rate of stroke | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse cerebrovascular events | Intervention at the 1-year |
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;
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.);
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junwei Hao | Contact | 010-83198277 | haojunwei@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junwei Hao | Xuanwu Hospital, Beijing | Study Chair |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 | 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 | 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)) | 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 | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| Prothrombin time | Prothrombin time (PT) will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of 11.0 to 13.0 seconds | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| C-reactive protein | Blood samples will be analyzed using immunoassay techniques on automated analyzers | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| Modified rankin scale score | The functional recovery of patients was evaluated using the modified rankin scale. The higher the score, the more serious it is | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| NIH stroke scale score | The neurological deficits on the NIHSS scale indicate that the higher the score, the more severe the stroke | Baseline |
| European five-dimensional five-level health scale score | It is used to assess an individual's health-related quality of life, consisting of two parts: a questionnaire and a visual analog scale (VAS). The questionnaire includes five dimensions, where higher scores indicate worse health status. The visual analog scale asks respondents to rate their overall health on a 0-100 scale, with higher scores reflecting better self-rated health status. | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| Minimum mental state examination | It is used to screen patients' cognitive conditions. The lower the score, the worse the cognition | Baseline; Intervention at 6-month and 1-year |
| Social support rate scale score | It is used to understand the support that patients receive in society, and the higher the score, the more support they receive | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| Depression anxiety stress scales - 21 score | It is used to understand the patient's emotional state. The higher the score, the worse the mood | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| Activated partial thromboplastin time | Activated partial thromboplastin time (aPTT) will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of 26.0 to 36.0 seconds, and may vary slightly depending on the reagents or testing techniques used. | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| International normalized ratio | International normalized ratio (INR) will be assessed using standard coagulation tests, it reflects the coagulation function, ,、 and the reference range for healthy people is 0.8 to 1.2, and may vary slightly depending on the medication or disease status. | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| Platelet count | Platelet count will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of (100～300）×10^9/L. | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| D-dimer | D-dimer will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of <0.3mg/L, and may vary slightly depending on the reagents or testing techniques used. | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |