An Application That Can Provide Early Warning of Temperature Health Risks and Give Protective Suggestions or Personalized Suggestions Based on Patients' Own Secondary Prevention Risk Factors Was Applied to Intervene, and the Intervention Effect of APP on Stroke Recurrence Risk Was Analyzed

NCT06904664 | Not Yet Recruiting

• 1 other identifier: [2024]444-003-1-3
• Study Type: interventional
• Target: 10,184
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study employs individualized temperature health risk early warning and risk factor management interventions for stroke, and explores their actual intervention effects. This enables patients to promptly understand their own risk levels and take corresponding protective measures, thereby enhancing the management outcomes and quality of life. The study also promotes the interdisciplinary integration of environmental epidemiology and clinical intervention management, providing new ideas and methodological support for future relevant research.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 1-year recurrence rate of stroke

  Intervention at the 1-year

Secondary Outcomes (10)

• 3-month, 6-month, 9-month recurrence rate of stroke

  Intervention at 3-month, 6-month, 9-month

• Cardiovascular system function indicators

  Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

• Laboratory examination

  Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

• Modified Rankin Scale

  Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

• European five-dimensional five-level Health Scale score

  Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

Other Outcomes (1)

• Incidence of adverse cerebrovascular events

  Intervention at the 1-year

Study Arms (4)

Enhanced intervention group

EXPERIMENTAL

Receive individualized temperature health risk warning and prevention risk factor management information for stroke through the application

Other: Individualized temperature health risk early warning and risk factor management

Temperature health risk early warning group

EXPERIMENTAL

Receive individualized temperature health risk warning through the application

Other: Temperature health risk early warning

Risk factor management group

EXPERIMENTAL

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

Other: Risk factor management

Routine education group

NO INTERVENTION

Only receive routine health education, without receiving individualized temperature health risk warning or prevention risk factor management information for stroke through the application

Interventions

Individualized temperature health risk early warning and risk factor management OTHER

Receive individualized temperature health risk warning and prevention risk factor management information for stroke through the application

Enhanced intervention group

Temperature health risk early warning OTHER

Receive individualized temperature health risk warning through the application

Temperature health risk early warning group

Risk factor management OTHER

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

Risk factor management group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.); ③ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Junwei Hao

CONTACT

010-83198277; haojunwei@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share