Telehealth Integrated Care Model in Patients With Cardiometabolic Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiometabolic Disease, Hyperlipidemia

Intervention / Treatment
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* Procedure: Telehealth integrated care
* Procedure: Conventional health care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telehealth Integrated Care Group<br>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<br>* Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.<br>|
| Conventional Group<br>Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education. | Procedure: Conventional health care<br>* Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Cardiometabolic Disease, Hyperlipidemia