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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Vascular Stenosis
• Intervention / Treatment: Behavioral: Digital health management

• Study Type: Interventional
• Enrollment (Estimated): 102072
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD, PhD; Phone Number: 0086 13756661217; Email: doctoryangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD, PhD; Phone Number: 0086 18186872986; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • First Hospital of Jilin University
      • Contact: Yi Yang, MD, PhD; Phone Number: 0086 13756661217; Email: doctoryangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital health management intervention Group; 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; 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.
No Intervention: Control group; 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?

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

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: head and neck vascular stenosis; digital health management
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: ENHEARTEN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No