First Hospital of Jilin University
Changchun, Jilin, 130000, China
Not Yet Recruiting
NCT Number: NCT05798013
Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
35 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Inclusion criteria of the clusters
Hospitals with the qualification of "head and neck ultrasound center" in China.
- 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
- Exclusion criteria for the clusters
The included centers did not have the capacity to undertake the trial.
- 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.
Treatment and study plan
Digital health management
BehavioralThe 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.
Primary outcomes
-
New-onset stroke events at 24 months
Time frame: 24 months
New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.
Secondary outcomes
-
New-onset stroke events at 12 months
Time frame: 12 months
New-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 months
Time frame: 12 months, 24 months
Clinical vascular events included ischemic stroke, transient ischemic attack, hemorrhagic stroke, myocardial infarction, and vascular death.
-
All-cause deaths at 24 months
Time frame: 24 months
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Yi Yang
Other
Registry information
Official study title
Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis: A Multicenter, Cluster Randomized Controlled Trial Based on Chinese Population
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Apr 4, 2023
- Registry last updated
- Oct 2, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.