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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06022575
Other study ID # PekingUTH Telehealth
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
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.

Study Design


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
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