Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital health management.
- Who it may be relevant to
- Registry conditions: Head and Neck Vascular Stenosis. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis: A Multicenter, Cluster Randomized Controlled Trial Based on Chinese Population
Overview
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
- 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.
Primary outcome measures
- New-onset stroke events at 24 months [Time frame: 24 months]
Secondary outcome measures (3)
- New-onset stroke events at 12 months [Time frame: 12 months]
- Composite and separate indicators of new clinical vascular events at 12 and 24 months [Time frame: 12 months, 24 months]
- All-cause deaths at 24 months [Time frame: 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT05798013 · ENHEARTEN