Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of digital health management for intervention on Chinese population with head and neck vascular stenosis.

Official Title
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Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis: A Multicenter, Cluster Randomized Controlled Trial Based on Chinese Population

Conditions
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Head and Neck Vascular Stenosis

Intervention / Treatment
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* Behavioral: Digital health management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria of the clusters Hospitals with the qualification of head and neck ultrasound center in China. Inclusion criteria for individuals (1)Age ≥ 35 years old, with no restriction on gender. (2)Patients with clinically diagnosed head and neck stenosis or occlusion, including mild, moderate or severe stenosis or occlusion of the carotid artery and mild, moderate or severe stenosis or occlusion of the intracranial artery. (3)Ability to use a smartphone and have a mobile application installed on the handset. (4)Subjects or their legal representatives agreed to the study and signed the project informed consent form. Exclusion Criteria: Exclusion criteria for the clusters The included centers did not have the capacity to undertake the trial. Exclusion criteria for individuals (1)Combination of severe systemic diseases such as respiratory failure, renal failure, gastrointestinal bleeding, coagulation dysfunction, malignancy, etc. (2)Patients with a life expectancy of less than 2 years or who are unable to complete the study for other reasons.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital health management intervention Group<br>Patients in the trial group receives intervention management from the digital health management platform, including reminding patients to take medication on time, monitoring and managing risk factors, reminding patients to have regular checkups and regular follow-ups, and pushing personalized science based on patients' risk factors, etc. Meanwhile, the platform's customer service staff regularly follows up with patients and reminds them of health management, and regularly invites experts to conduct formal medical science conferences for patients. | Behavioral: Digital health management<br>* The digital health management platform mainly includes reminding patients to take medication on time, monitoring and managing risk factors, reminding patients of regular review and regular follow-up, pushing personalized science according to patients' risk factors, etc., as well as following up and supervising patients' health management, and conducting regular formal medical science conferences.<br>|
| No Intervention: Control group<br>The group doesn't not receive intervention reminders and customer service supervision from the platform, but receives the same follow-up visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New-onset stroke events at 24 months | New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New-onset stroke events at 12 months | New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke. | 12 months | 
| Composite and separate indicators of new clinical vascular events at 12 and 24 months | Clinical vascular events included ischemic stroke, transient ischemic attack, hemorrhagic stroke, myocardial infarction, and vascular death. | 12 months, 24 months | 
| All-cause deaths at 24 months |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck vascular stenosis, digital health management