Acute Ischemic Stroke
Conditions
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.
Interventions
Receive individualized prevention risk factor management information for stroke through the application
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence rate of stroke | Intervention at the 1-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health literacy scale score | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | 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 |
| System usability scale score | Intervention at 3-month, 6-month, 9-month and 1-year | It is used to understand the subjects' satisfaction and usability evaluation of the intelligent program. The higher the score, the better the evaluation |
| Blood pressure | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | Systolic and diastolic blood pressure will be measured using a standard automated sphygmomanometer |
| Electrocardiogram (ECG) parameters | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | 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)) |
| Fasting blood glucose | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | Fasting plasma glucose levels will be measured to assess glycemic control |
| C-reactive protein | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | Blood samples will be analyzed using immunoassay techniques on automated analyzers |
| Prothrombin time | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | 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 |
| Modified rankin scale score | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | The functional recovery of patients was evaluated using the modified rankin scale. The higher the score, the more serious it is |
| NIH stroke scale score | Baseline | The neurological deficits on the NIHSS scale indicate that the higher the score, the more severe the stroke |
| 3-month, 6-month, 9-month recurrence rate of stroke | Intervention at 3-month, 6-month, 9-month | — |
| Minimum mental state examination | Baseline; Intervention at 6-month and 1-year | It is used to screen patients' cognitive conditions. The lower the score, the worse the cognition |
| Social support rate scale score | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | It is used to understand the support that patients receive in society, and the higher the score, the more support they receive |
| Depression anxiety stress scales - 21 score | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | It is used to understand the patient's emotional state. The higher the score, the worse the mood |
| D-dimer | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | 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. |
| Activated partial thromboplastin time | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | 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. |
| International normalized ratio | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | 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. |
| Platelet count | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | Platelet count will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of (100～300）×10\^9/L. |
| European five-dimensional five-level health scale score | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | 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. |
Other
| Measure | Time frame |
|---|---|
| Incidence of adverse cerebrovascular events | Intervention at the 1-year |
Contacts
Primary ContactJunwei Hao
Outcome results
None listed