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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Digital health management

About this trial

This is an interventional prevention trial for Head and Neck Vascular Stenosis focused on measuring head and neck vascular stenosis, digital health management

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Digital health management intervention Group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

New-onset stroke events at 24 months

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

Secondary Outcome Measures

New-onset stroke events at 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

Clinical vascular events included ischemic stroke, transient ischemic attack, hemorrhagic stroke, myocardial infarction, and vascular death.

All-cause deaths at 24 months

Full Information

NCT ID

NCT05798013

First Posted

March 22, 2023

Last Updated

July 17, 2023

Sponsor

Yi Yang

1. Study Identification

Unique Protocol Identification Number

NCT05798013

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 2023 (Anticipated)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Vascular Stenosis

Keywords

head and neck vascular stenosis, digital health management

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

102072 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Digital health management intervention Group

Arm Type

Experimental

Arm 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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Digital health management

Intervention Description

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 Measure Information:

Title

New-onset stroke events at 24 months

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

New-onset stroke events at 12 months

Description

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

Time Frame

12 months

Title

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

Description

Clinical vascular events included ischemic stroke, transient ischemic attack, hemorrhagic stroke, myocardial infarction, and vascular death.

Time Frame

12 months, 24 months

Title

All-cause deaths at 24 months

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Yang, MD, PhD

Phone

13756661217

Ext

0086

Email

doctoryangyi@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenni Guo, MD, PhD

Phone

18186872986

Ext

0086

Email

zhen1ni2@163.com

Facility Information:

Facility Name

First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Yang, MD, PhD

Phone

13756661217

Ext

0086

Email

doctoryangyi@163.com

Head and Neck Vascular Stenosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial