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

NCT05798013 | Not Yet Recruiting DMC

• 1 other identifier: ENHEARTEN
• Study Type: interventional
• Target: 102,072
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Vascular Stenosis

Keywords

head and neck vascular stenosis; digital health management

Outcome Measures

Primary Outcomes (1)

• New-onset stroke events at 24 months

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

  24 months

Secondary Outcomes (3)

• New-onset stroke events at 12 months

  12 months

• Composite and separate indicators of new clinical vascular events at 12 and 24 months

  12 months, 24 months

• All-cause deaths at 24 months

  24 months

Study Arms (2)

Digital health management intervention Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The group doesn't not receive intervention reminders and customer service supervision from the platform, but receives the same follow-up visits.

Interventions

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.

Digital health management intervention Group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

13756661217; doctoryangyi@163.com

Zhenni Guo, MD, PhD

CONTACT

18186872986; zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

CN (1)