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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06904664
Enrollment
10184
Registered
2025-04-01
Start date
2025-09-01
Completion date
2028-08-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

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.

Interventions

OTHERIndividualized 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

Receive individualized temperature health risk warning through the application

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

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

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.); 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).

Design outcomes

Primary

MeasureTime frame
1-year recurrence rate of strokeIntervention at the 1-year

Secondary

MeasureTime frameDescription
Cardiovascular system function indicatorsBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearSuch as blood pressure, various electrocardiogram indicators and other examination results that can reflect cardiovascular function
Laboratory examinationBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearSuch as results of laboratory tests including lipid profiles, blood glucose, coagulation, and other laboratory indicators.
Modified Rankin ScaleBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearThe 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.
European five-dimensional five-level Health Scale scoreBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearThe 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.
Risk perception scale of stroke recurrenceBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearThe 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.
3-month, 6-month, 9-month recurrence rate of strokeIntervention at 3-month, 6-month, 9-month
Stroke health literacy scoreBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearThe scale uses a five-point scoring method, with a higher score indicating a higher level of stroke health literacy.
Health status scoreBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearSuch as barthel index (BI) and other scoring scales for evaluating patients' disease recovery, physical condition and other abilities
System usability scaleIntervention at 3-month, 6-month, 9-month and 1-year
Environmental temperature health risk perception assessment 1uestionnaireBaseline; Intervention at 3-month, 6-month, 9-month and 1-yearHere are multiple questions related to environmental risk factors and health risks, each using a 0-100 scale where a higher score indicates greater understanding

Other

MeasureTime frame
Incidence of adverse cerebrovascular eventsIntervention at the 1-year

Contacts

Primary ContactJunwei Hao
haojunwei@vip.163.com010-83198277

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026