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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorYi Yang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion criteria of the clusters

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.

Disqualifiers

Exclusion criteria for the clusters

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital health management

    Behavioral

    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.

Treatment groups

102,072 Participants
are divided into 2 treatment groups
Group A: Digital health management intervention GroupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

New-onset stroke events at 24 months

New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.

Time frame
24 months

Secondary outcomes

1

New-onset stroke events at 12 months

New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.

Time frame
12 months
2

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.

Time frame
12 months, 24 months
3

All-cause deaths at 24 months

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: