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

Individualized Temperature Health Risk Early Warning and Risk Factor Management App for Reducing the Recurrence Risk of Stroke: A Multicenter, Randomized Controlled Trial Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Individualized temperature health risk early warning and risk factor management; Other: Temperature health risk early warning; Other: Risk factor management

• Study Type: Interventional
• Enrollment (Estimated): 10184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junwei Hao; Phone Number: 010-83198277; Email: haojunwei@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.); 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.

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced intervention group; 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; Receive individualized temperature health risk warning and prevention risk factor management information for stroke through the application
Experimental: Temperature health risk early warning group; Receive individualized temperature health risk warning through the application	Other: Temperature health risk early warning; Receive individualized temperature health risk warning through the application
Experimental: Risk factor management group; Receive individualized prevention risk factor management information for stroke through the application	Other: Risk factor management; Receive individualized prevention risk factor management information for stroke through the application
No Intervention: Routine education group; Only receive routine health education, without receiving individualized temperature health risk warning or prevention risk factor management information for stroke through the application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1-year recurrence rate of stroke	Intervention at the 1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month, 6-month, 9-month recurrence rate of stroke		Intervention at 3-month, 6-month, 9-month
Cardiovascular system function indicators	Such as blood pressure, various electrocardiogram indicators and other examination results that can reflect cardiovascular function	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Laboratory examination	Such as results of laboratory tests including lipid profiles, blood glucose, coagulation, and other laboratory indicators.	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Modified Rankin Scale	The Modified Rankin Scale (mRS) is a scale used to assess the neurological recovery status and disability level in stroke patients. The scale ranges from zero to six, divided into seven levels, with higher grades indicating worse conditions.	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
European five-dimensional five-level Health Scale score	The scale includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension containing five levels. It also includes a 0-100 scale, where a lower score indicates worse condition.	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Risk perception scale of stroke recurrence	The scale uses a Likert three-point scoring method, assigning values of 1, 2, and 3 for the responses "disagree," "uncertain," and "agree," respectively. A higher score indicates a higher level of perceived ability.	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Environmental temperature health risk perception assessment 1uestionnaire	Here are multiple questions related to environmental risk factors and health risks, each using a 0-100 scale where a higher score indicates greater understanding	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Stroke health literacy score	The scale uses a five-point scoring method, with a higher score indicating a higher level of stroke health literacy.	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Health status score	Such as barthel index (BI) and other scoring scales for evaluating patients' disease recovery, physical condition and other abilities	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
System usability scale		Intervention at 3-month, 6-month, 9-month and 1-year

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse cerebrovascular events	Intervention at the 1-year

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: [2024]444-003-1-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No