Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05798013
Enrollment
102072
Registered
2023-04-04
Start date
2025-10-31
Completion date
2028-10-31
Last updated
2024-10-02

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

Conditions

Head and Neck Vascular Stenosis

Keywords

head and neck vascular stenosis, digital health management

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.

Interventions

BEHAVIORALDigital health management

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.

Sponsors

Yi Yang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
New-onset stroke events at 24 months24 monthsNew-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.

Secondary

MeasureTime frameDescription
New-onset stroke events at 12 months12 monthsNew-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.
Composite and separate indicators of new clinical vascular events at 12 and 24 months12 months, 24 monthsClinical vascular events included ischemic stroke, transient ischemic attack, hemorrhagic stroke, myocardial infarction, and vascular death.
All-cause deaths at 24 months24 months

Countries

China

Contacts

Primary ContactYi Yang, MD, PhD
doctoryangyi@163.com13756661217
Backup ContactZhenni Guo, MD, PhD
zhen1ni2@163.com18186872986

Outcome results

None listed

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