Head and Neck Vascular StenosisNCT05798013
Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis
A study testing Digital health management in people with Head and Neck Vascular Stenosis, run by Yi Yang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Head and Neck Vascular Stenosis
- What is being tested?
- Digital health management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102,072 participants
- Where
- 1 siteChina
- Study dates
- Oct 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, 13756661217 ext. 0086, doctoryangyi@163.com
About this study
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
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
- Being tested
- Digital health management
- Keywords
- head and neck vascular stenosis, digital health management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital health managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New-onset stroke events at 24 months
New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.
Measured: 24 months
Secondary outcomes (3)
New-onset stroke events at 12 months
New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.
Measured: 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.
Measured: 12 months, 24 months
All-cause deaths at 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Vascular StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102,072 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798013
- Sponsor's protocol ID
- ENHEARTEN
- Status last verified
- Oct 2024
- First submitted
- 22 Mar 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05798013
- Acronym / sponsor ID
- ENHEARTEN
- Conditions
- Head and Neck Vascular Stenosis
- Keywords
- head and neck vascular stenosis, digital health management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102,072 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital health management intervention Group | Experimental | Behavioral: Digital health managementPatients 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. |
| 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion criteria of the clusters
- Hospitals with the qualification of "head and neck ultrasound center" in China.
- Inclusion criteria for individuals
Key exclusion criteria (5 listed)
- Exclusion criteria for the clusters
- The included centers did not have the capacity to undertake the trial.
- Exclusion criteria for individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital health managementThe 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. | Behavioural | Digital health management intervention Group |
Primary outcome
New-onset stroke events at 24 months
Time frame: 24 months
New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital health management in people with Head and Neck Vascular Stenosis, run by Yi Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD, PhD (13756661217 ext. 0086, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New-onset stroke events at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.