Telehealth Integrated Care Model in Patients With Cardiometabolic Disease

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06022575
Collaborator
(none)
1,302
1
25
52.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Telehealth integrated care
  • Procedure: Conventional health care

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1302 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Telehealth Integrated Care Model in Patients With Hyperlipidemia and Other Cardiometabolic Disease
Actual Study Start Date :
Jun 20, 2023
Anticipated Primary Completion Date :
Jun 20, 2024
Anticipated Study Completion Date :
Jul 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Telehealth Integrated Care Group

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
Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.

Conventional Group

Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.

Procedure: Conventional health care
Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. changes of glycosylated hemoglobin [12 month after recuitment]

    difference of glycosylated hemoglobin between endpoint with baseline

  3. changes of fasting glucose [12 month after recuitment]

    difference of fasting glucose between endpoint with baseline

  4. changes of LDL-c [12 month after recuitment]

    difference of LDL-c between endpoint with baseline

  5. changes of triglyceride [12 month after recuitment]

    difference of triglyceride between endpoint with baseline

  6. abnormal liver function [12 month after recuitment]

    an increase above the 3-fold normal value for ALT or AST.

  7. abnormal kidney function [12 month after recuitment]

    an increase in creatinine of ≥ 30%

  8. Rehospitalization [12 month]

    Rehospitalization because of coronary heart disease, poor blood pressure control, and poor glycemic control

  9. Cardiovascular death [12 month]

    Death because of cardiovascular diseases and sudden death

  10. medication adherence rate [12 month]

    Difference of medication adherence between each group measured by Morisky Medication Adherence Scale-8

  11. 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.

  12. medical cost [12 month]

    Health Economics on medical cost, transportation cost, accommodation cost, waiting time and lost work time

  13. in person visit counts [12 month after recuitment]

    total number of in person visits

  14. telehealth visit counts [12 month after recuitment]

    total number of telehealth visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 85 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing Beijing China

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Principal Investigator: Lin Zeng, Ph.D, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeng Lin, Ph. D., Deputy Director of Research Center of Clinical Epidemiology, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT06022575
Other Study ID Numbers:
  • PekingUTH Telehealth
First Posted:
Sep 5, 2023
Last Update Posted:
Sep 5, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeng Lin, Ph. D., Deputy Director of Research Center of Clinical Epidemiology, Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2023