Clinical trial NCT06022575: Telehealth Integrated Care Model in Patients With Cardiometabolic Disease
Official title: Evaluation of the Telehealth Integrated Care Model in Patients With Hyperlipidemia and Other Cardiometabolic Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiometabolic Disease
Hyperlipidemia
Keywords: Telehealth
Cardiometabolic Disease
Hyperlipidemia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 1302
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiometabolic Disease

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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes of compliance rate of target treatment for hyperlipidemia
timeFrame: 12 month after recuitment
Secondary outcomes:
measure: changes of blood pressure
timeFrame: 12 month after recuitment
measure: changes of glycosylated hemoglobin
timeFrame: 12 month after recuitment
measure: changes of fasting glucose
timeFrame: 12 month after recuitment
measure: changes of LDL-c
timeFrame: 12 month after recuitment
measure: changes of triglyceride
timeFrame: 12 month after recuitment
measure: abnormal liver function
timeFrame: 12 month after recuitment
measure: abnormal kidney function
timeFrame: 12 month after recuitment
measure: Rehospitalization
timeFrame: 12 month
measure: Cardiovascular death
timeFrame: 12 month
measure: medication adherence rate
timeFrame: 12 month
measure: patients satisfaction
timeFrame: 12 month
measure: medical cost
timeFrame: 12 month
measure: in person visit counts
timeFrame: 12 month after recuitment
measure: telehealth visit counts
timeFrame: 12 month after recuitment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Lin Zeng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: