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

Yi Yang

Status: Not yet enrolling

Conditions: Head and Neck Vascular Stenosis

Treatments: Behavioral: Digital health management

Study type: Interventional

Funder types: Other

Identifiers

NCT05798013

ENHEARTEN

Details and patient eligibility

About

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.

Enrollment: 102,072 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102,072 participants in 2 patient groups

Digital health management intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Digital health management

Control group

No Intervention group

Description:

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