Application and Evaluation of Telehealth-Based Chronic Disease Management for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,636
- 主要终点
- the proportion of patients achieved all three targets (HbA1c < 7.0%, blood pressure < 130/80 mmHg and LDL-cholesterol < 2.6 mmol/L)
研究概览
简要总结
This study will be conducted from enrollment until the end of the six-month follow-up period.
This study aims to assess the impact of the Internet hospital online + offline integrated chronic disease management model on patients with type 2 diabetes mellitus. It will also evaluate the economic impact of the model and identify the characteristics of the appropriate population for the model. Finally, it will develop a toolkit to help manage chronic diseases.
The study will include 1,636 patients with type 2 diabetes who did not reach the standard of control target of glucose, blood pressure or LDL at the endocrine outpatient clinic and inpatient wards of the Third Hospital of Peking University. We will collect information from participants before the study starts. And the patients will be followed up for 6 months from enrollment. The study management mode included online and offline integrated management in the Internet hospital, and routine offline management mode. After completing the enrollment and assessment, we will arrange outpatient follow-up and management according to the current status, doctor's requirements, and study subjects' needs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old;
- •Confirmed diagnosis of type 2 diabetes mellitus;
- •Ability to use smartphones to participate in online diagnosis and treatment;
- •Ability of the patient or relatives to assist the patient in self-monitoring of blood glucose;
- •Failure to meet control targets: glycated hemoglobin ≥
- •0%, or LDL-C ≥ 2.6 mmol/L (and ASCVD or definite atherosclerosis with stenosis ≥ 1.8 mmol/L), or blood pressure > 130% and ≥ 1.8 mmol/kg. L), or blood pressure over 130/80 mmHg.
排除标准
- •Mental illness, cognitive dysfunction;
- •Other diseases and complex conditions (untreated tumors, heart disease within 3 months);
- •Acute complications of diabetes, severe hyperglycemia, fasting glucose greater than 16.9 mmol / L, random glucose greater than 20 mmol / L. Diabetic ketoacidosis and hypoglycemic coma that are not suitable for online management of diabetes emergencies;
- •Patients with severe chronic complications of diabetes in critical condition (blindness, vision deterioration, new onset of ASCVD symptoms);
- •Those who are unsuitable for the study: infection, fracture, trauma, foot ulceration, edema, blindness, cardiovascular emergencies, coma, etc;
- •Those who have not signed the informed consent form.
结局指标
主要结局
the proportion of patients achieved all three targets (HbA1c < 7.0%, blood pressure < 130/80 mmHg and LDL-cholesterol < 2.6 mmol/L)
时间窗: at 6±1 month from the enrollment
次要结局
- patient satisfaction using Visual Analogue Scale (VAS)(at 6±1 month from the enrollment)
- Hospitalization for any reason(at 6±1 month from the enrollment)
- patient adherence using 8-item Morisky Medication Adherence Scale (MMAS-8)(at 6±1 month from the enrollment)
- Hypoglycemic events(at 6±1 month from the enrollment)
- Acute complications(at 6±1 month from the enrollment)
- blood glucose level(at 6±1 month from the enrollment)
- blood pressure assessment(at 6±1 month from the enrollment)
- Laboratory tests for blood lipid level (Total Cholesterol, TC)(at 6±1 month from the enrollment)
- Laboratory tests for blood lipid level (Low Density Lipoprotein-Cholesterol, LDL-C)(at 6±1 month from the enrollment)
- diabetes self-management ability using Summary of Diabetes Self-Care Activities Questionnaire (C-SDSCA)(at 6±1 month from the enrollment)
- diabetes self-management ability using Confidence in Diabetes Management Self-Efficacy Scale (C-DMSES)(at 6±1 month from the enrollment)
- Direct Medical Cost(at 6±1 month from the enrollment)
- Laboratory tests for blood lipid level (Triglycerides, TG)(at 6±1 month from the enrollment)
- Laboratory tests for blood lipid level (High Density Lipoprotein-Cholesterol, HDL-C)(at 6±1 month from the enrollment)
研究者
Zeng Lin, Ph. D.
Deputy Director of Peking University Third Hospital Research Center of Clinical Epidemiology
Peking University Third Hospital