Telehealth Integrated Care Model in Patients With Cardiometabolic Disease

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022575
• Other study ID #: PekingUTH Telehealth
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: July 20, 2025

Study information

• Verified date: September 2023
• Source: Peking University Third Hospital
• Contact: Lequn Zhou, Dr
• Phone: +86 1082266280
• Email: zhoulequnde[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1302
• Est. completion date: July 20, 2025
• Est. primary completion date: June 20, 2024
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Disease
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	changes of glycosylated hemoglobin	difference of glycosylated hemoglobin between endpoint with baseline	12 month after recuitment
Secondary	changes of fasting glucose	difference of fasting glucose between endpoint with baseline	12 month after recuitment
Secondary	changes of LDL-c	difference of LDL-c between endpoint with baseline	12 month after recuitment
Secondary	changes of triglyceride	difference of triglyceride between endpoint with baseline	12 month after recuitment
Secondary	abnormal liver function	an increase above the 3-fold normal value for ALT or AST.	12 month after recuitment
Secondary	abnormal kidney function	an increase in creatinine of = 30%	12 month after recuitment
Secondary	Rehospitalization	Rehospitalization because of coronary heart disease, poor blood pressure control, and poor glycemic control	12 month
Secondary	Cardiovascular death	Death because of cardiovascular diseases and sudden death	12 month
Secondary	medication adherence rate	Difference of medication adherence between each group measured by Morisky Medication Adherence Scale-8	12 month
Secondary	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
Secondary	medical cost	Health Economics on medical cost, transportation cost, accommodation cost, waiting time and lost work time	12 month
Secondary	in person visit counts	total number of in person visits	12 month after recuitment
Secondary	telehealth visit counts	total number of telehealth visits	12 month after recuitment