Acute Ischemic Stroke
Conditions
Brief summary
This study applied an application to provide early warnings and advice for stroke patients and explored the impact of this intervention on reducing the risk of stroke recurrence
Detailed description
This study applied an application that provides individualized environmental temperature-related health risk warnings and recommendations to stroke patients, enabling them to promptly understand their risk levels and take corresponding 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 temperature health risk warning 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; * 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.); ⑥ 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 |
|---|---|---|
| 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)) |
| Environmental temperature health risk perception assessment questionnaire | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | It is used to assess patients' understanding and concern about health hazards related to temperature. 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 |
| Lipid Profile (Total Cholesterol, LDL-C, HDL-C, and Triglycerides) | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | Plasma lipid levels will be measured using standard laboratory assays, including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG). |
| 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. |
| Coagulation parameters (Prothrombin Time, aPTT, INR, Fibrinogen, Platelet Count and D-dimer) | Baseline; Intervention at 3-month, 6-month, 9-month and 1-year | Coagulation status will be assessed using standard coagulation tests, including prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalized ratio (INR), fibrinogen level, platelet count and D-dimer. |
| 3-month, 6-month, 9-month recurrence rate of stroke | Intervention at 3-month, 6-month, 9-month | — |
| 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 |
| 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. |
| 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Incidence of adverse cerebrovascular events | Intervention at the 1-year |
Contacts
Primary ContactJunwei Hao
Outcome results
None listed