An Application Provides Personalized Suggestions Based on Secondary Prevention Risk Factors to Stroke Patients
- Conditions
- Acute Ischemic Stroke
- Registration Number
- NCT07098143
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 5092
-
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.
-
-
-
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).
-
-
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 1-year recurrence rate of stroke Intervention at the 1-year
- Secondary Outcome Measures
Name Time Method 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
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 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
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
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
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
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
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
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
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.
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.
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.
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
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.