Hyperlipidemia Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 1302 |
Est. completion date | July 20, 2025 |
Est. primary completion date | June 20, 2024 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
Completed |
NCT04640012 -
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03213288 -
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
|
N/A | |
Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
Recruiting |
NCT02979704 -
A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
|
Phase 2/Phase 3 | |
Completed |
NCT02569814 -
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
|
Phase 1 | |
Completed |
NCT02280590 -
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
|
Phase 4 | |
Completed |
NCT02428998 -
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
|
N/A | |
Completed |
NCT01678183 -
Financial Incentives for Medication Adherence
|
N/A | |
Completed |
NCT01694446 -
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
|
N/A | |
Completed |
NCT01426412 -
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
|
Phase 1 | |
Completed |
NCT01131832 -
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
|
Phase 4 | |
Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
Completed |
NCT00758303 -
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
|
Phase 2/Phase 3 | |
Recruiting |
NCT00408824 -
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
|
N/A | |
Completed |
NCT00362206 -
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
|
Phase 3 | |
Terminated |
NCT00299169 -
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
|
Phase 4 | |
Completed |
NCT00414986 -
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
|
N/A | |
Completed |
NCT00381992 -
Risk Assessment of Long-Haul Truck Drivers
|
N/A |