Telehealth Integrated Care Model in Patients With Cardiometabolic Disease

Recruiting

• Conditions: Cardiometabolic Disease; Hyperlipidemia
• Interventions: Procedure: Telehealth integrated care; Procedure: Conventional health care

• Registration Number: NCT06022575
• Lead Sponsor: Peking University Third Hospital

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.

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 Timeline

• Study Start: 2023-06-20
• Study First Submitted: 2023-07-07
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-05
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-06-20
• Study Completion: 2025-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1302

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Telehealth Integrated Care Group	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	Conventional health care	Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.

Primary Outcome Measures

Name	Time	Method
changes of compliance rate of target treatment for hyperlipidemia	12 month after recuitment	difference of compliance rate of target treatment for hyperlipidemia between endpoint with baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China