Telehealth Integrated Care Model in Patients With Cardiometabolic Disease

Evaluation of the Telehealth Integrated Care Model in Patients With Hyperlipidemia and Other Cardiometabolic Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemia; Cardiometabolic Disease
• Intervention / Treatment: Procedure: Telehealth integrated care; Procedure: Conventional health care

Detailed Description

Efficacy evaluation is critical for understanding the practical application effect of telehealth integrated mode in the therapy of cardiometabolic disease patients. We can comprehend the influence of the combination of online and offline models on patients' clinical curative effect, medication compliance, medical cost, and satisfaction by analyzing the curative effect and finding a scientific basis for clinical practice and policy formation. As a result, the purpose of this study is to assess the curative effect of hyperlipidemia patients with other cardiometabolic disease using a telehealth integrated model, as well as to investigate the potential benefits and risks of this model in the management of cardiometabolic disease.

• Study Type: Observational
• Enrollment (Estimated): 1302

Contacts and Locations

• Study Contact: Name: Lequn Zhou, Dr; Phone Number: +86 1082266280; Email: zhoulequnde@126.com
• Study Contact Backup: Name: Yipei Wang, Ph.D; Phone Number: +86 1082266191; Email: yipeiw@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Lequn Zhou; Email: zhoulequnde@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Cardiometabolic Disease

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.
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; Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of blood pressure	difference of blood pressure（both systolic and diastolic blood pressure will be measured.） between endpoint with baseline	12 month after recuitment
changes of glycosylated hemoglobin	difference of glycosylated hemoglobin between endpoint with baseline	12 month after recuitment
changes of fasting glucose	difference of fasting glucose between endpoint with baseline	12 month after recuitment
changes of LDL-c	difference of LDL-c between endpoint with baseline	12 month after recuitment
changes of triglyceride	difference of triglyceride between endpoint with baseline	12 month after recuitment
abnormal liver function	an increase above the 3-fold normal value for ALT or AST.	12 month after recuitment
abnormal kidney function	an increase in creatinine of ≥ 30%	12 month after recuitment
Rehospitalization	Rehospitalization because of coronary heart disease, poor blood pressure control, and poor glycemic control	12 month
Cardiovascular death	Death because of cardiovascular diseases and sudden death	12 month
medication adherence rate	Difference of medication adherence between each group measured by Morisky Medication Adherence Scale-8	12 month
patients satisfaction	patients will be asked to rate their satisfaction score in Likert form with 1 being the most unsatisfactory and 5 being the most satisfactory on the overall experience, the medical diagnosis process, service attitude and physician's professionalism.	12 month
medical cost	Health Economics on medical cost, transportation cost, accommodation cost, waiting time and lost work time	12 month
in person visit counts	total number of in person visits	12 month after recuitment
telehealth visit counts	total number of telehealth visits	12 month after recuitment

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Lin Zeng, Ph.D, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): July 20, 2025

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; Hyperlipidemia; Cardiometabolic Disease
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: PekingUTH Telehealth

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No