NCT06022575

Brief Summary

The objective of this study is to evaluate the telehealth integrated care model for its clinical efficacy, medical resource utilization, health economics measurement, and satisfaction survey indicators in hyperlipidemia patients and other cardiometabolic diseases. The result of the study will provide evidence for the value of integrated model in the treatment of patients with cardiometabolic syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

July 7, 2023

Last Update Submit

September 1, 2023

Conditions

Cardiometabolic DiseaseHyperlipidemia

Keywords

TelehealthCardiometabolic DiseaseHyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • changes of compliance rate of target treatment for hyperlipidemia

    difference of compliance rate of target treatment for hyperlipidemia between endpoint with baseline

    12 month after recuitment

Secondary Outcomes (14)

  • changes of blood pressure

    12 month after recuitment

  • changes of glycosylated hemoglobin

    12 month after recuitment

  • changes of fasting glucose

    12 month after recuitment

  • changes of LDL-c

    12 month after recuitment

  • changes of triglyceride

    12 month after recuitment

  • +9 more secondary outcomes

Study Arms (2)

Telehealth Integrated Care Group

Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.

Procedure: Telehealth integrated care

Conventional Group

Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.

Procedure: Conventional health care

Interventions

Telehealth integrated carePROCEDURE

Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.

Telehealth Integrated Care Group
Conventional health carePROCEDURE

Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.

Conventional Group

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiometabolic Disease

You may qualify if:

  • Age ≥ 16 years, and ≤ 85 years;
  • Diagnosis as hyperlipidemia with at least one of the following disease: hypertension or type 2 diabetes mellitus;
  • Agreed to be enrolled in this study.

You may not qualify if:

  • Undergone percutaneous coronary intervention within one year in our hospital;
  • Severe LV dysfunction, such as LV ejection fraction \< 35%, or congestive heart failure with New York Heart Association (NYHA) functional class IV or Killip class IV;
  • Structural heart disease, or severe arrhythmia;
  • Severe liver or kidney diseases, endocrinology diseases, hematologic diseases, rheumatic immune system diseases, and malignancy;
  • could not complete at least one-year-followup.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lin Zeng, Ph.D

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lequn Zhou, Dr

CONTACT

+86 1082266280zhoulequnde@126.com

Yipei Wang, Ph.D

CONTACT

+86 1082266191yipeiw@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Research Center of Clinical Epidemiology

Study Record Dates

First Submitted

July 7, 2023

First Posted

September 5, 2023

Study Start

June 20, 2023

Primary Completion

June 20, 2024

Study Completion

July 20, 2025

Last Updated

September 5, 2023

Record last verified: 2023-09

Locations

CN(1)