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

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Vascular Stenosis
• Interventions: Behavioral: Digital health management

• Registration Number: NCT05798013
• Lead Sponsor: Yi Yang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Study Start: 2025-10
• Primary Completion: 2027-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102072

Inclusion Criteria

1. Inclusion criteria of the clusters

   Hospitals with the qualification of "head and neck ultrasound center" in China.

2. 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

1. Exclusion criteria for the clusters

   The included centers did not have the capacity to undertake the trial.

2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital health management intervention Group	Digital health management	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.

Primary Outcome Measures

Name	Time	Method
New-onset stroke events at 24 months	24 months	New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China