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Not yet recruiting NCT07098143

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

No phase Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Risk factor management.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Individualized Risk Factor Management Application for Reducing the Recurrence Risk of Stroke: A Multicenter, Randomized Controlled Trial Study

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

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

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

Primary outcome measures

  • 1-year recurrence rate of stroke [Time frame: Intervention at the 1-year]
Secondary outcome measures (12)
  • 3-month, 6-month, 9-month recurrence rate of stroke [Time frame: Intervention at 3-month, 6-month, 9-month]
  • Health literacy scale score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • System usability scale score [Time frame: Intervention at 3-month, 6-month, 9-month and 1-year]
  • Blood pressure [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Electrocardiogram (ECG) parameters [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Fasting blood glucose [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Prothrombin time [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • C-reactive protein [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Modified rankin scale score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • NIH stroke scale score [Time frame: Baseline]
  • European five-dimensional five-level health scale score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Minimum mental state examination [Time frame: Baseline; Intervention at 6-month and 1-year]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07098143 · [2024]444-003-1-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗