Effects of the General Practitioners and Diabetes Specialists Co-management Model for Patients With Type 2 Diabetes in the Community: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 609
- 试验地点
- 1
- 主要终点
- HbA1c change
研究概览
简要总结
This is a prospective, randomized, parallel, multicenter controlled study to evaluate the effectiveness of the general practitioners and diabetes specialists co-management model for type 2 diabetes. Patients with type 2 diabetes will be randomized to participate in the community general practitioners and diabetes specialists management or serve as controls continuing with routine primary health care. The primary outcome is to observe the HbA1c change.
详细描述
Aim: This study constructs a general practitioner and diabetes specialist co-management model for patients with type 2 diabetes in the community based on the integration of prevention and treatment strategies. Also, the effectiveness of the model will be evaluated by a parallel randomized controlled trial design to provide theoretical support and empirical evidence for the development of a comprehensive management strategy for patients with type 2 diabetes.
Hypothesis: Compared to the control group, the intervention group receiving co-management by general practitioners and diabetes specialists has a greater improvement in HbA1c, fasting glucose, blood pressure, lipids, BMI, diabetes self-management ability, depression symptoms, diabetes distress, and diabetes complications-related indicators.
Recruiting: This study will recruit patients with type 2 diabetes who have established electronic health records in 5 community healthcare centers affiliated with the Baoan Central Hospital of Shenzhen. General practitioners at the community healthcare centers screen patients with type 2 diabetes under their care who are eligible for the study based on the inclusion and exclusion criteria. Following face-to-face communication, general practitioners explain the study objectives and procedures to patients and obtain their informed consent.
Before the start of the study, unified training will be conducted for the general practitioners involved in the recruitment so that they can clarify the inclusion and exclusion criteria, screening methods, and precautions regarding the study objects.
Randomization Procedure: Members of the research team served as the grouping scheme controllers of the randomization center. The Proc plan procedure of SAS 9.4 statistical software was used to generate random number sequences and grouping schemes according to a 1:1 assignment. For the patients with type 2 diabetes who met the inclusion and exclusion criteria, general practitioners contacted randomization center staff members by telephone according to the patients' order of arrival at the community healthcare center and informed them of the patient's name and ID number. Then the randomization center staff recorded patient information, numbered the patients, and divided them into an intervention group or control group according to the previously generated random number table. Finally, the randomization center staff informed patients' general practitioners of their grouping results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant will be blinded of which treatment group subject is assigned to.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes for over 1 year according to the diagnostic criteria of diabetes formulated by the World Health Organization;
- •Male or female residents aged 18-85 years;
- •HbA1c measured within 6 months before enrollment was 7.0%-10.0%;
- •Lived in the catchment and have established health records for at least 6 months, and have no plans to move out at present;
- •patients used smartphones;
- •Sign the informed consent and participate in the study voluntarily.
排除标准
- •Patients used insulin within 1year before enrollment;
- •patients with type 1 diabetes, Latent autoimmune diabetes of adults(LADA), gestational diabetes, patients with extremely poor islet function (fasting C-peptide < 0.1ng/ml) and patients with special type of diabetes;
- •Patients used continuous glucose monitoring (CGM) in the past 3 months;
- •Patients with serious complications (such as Stage G5 of diabetic nephropathy, severe loss of vision or blindness due to diabetic retinopathy and patients without self-care ability due to diabetic foot amputation).
- •Patients who suffered from serious mental illness or late stage of other serious diseases (such as malignant tumors, acute cardiovascular disease (like stroke, myocardial infarction), serious liver insufficiency, patients with history of diabetic ketoacidosis, patients with alcohol or drug abuse or dependence and patients with a history of cardiac surgery in the last 3 months;
- •Patients with cognitive impairment, or patients unable to use mobile phones to answer calls.
结局指标
主要结局
HbA1c change
时间窗: Baseline, 6, and 18 months
The change of HbA1c during the study. The level of HbA1c in blood measured in %.
次要结局
- Fasting Plasma Glucose(Baseline, 6, and 18 months)
- Total cholesterol(Baseline, 6, and 18 months)
- Triglycerides(Baseline, 6, and 18 months)
- LDL-C(Baseline, 6, and 18 months)
- HDL-C(Baseline, 6, and 18 months)
- Blood pressure(Baseline, 6, and 18 months)
- Body Mass Index (BMI)(Baseline, 6, and 18 months)
- Diabetes self-care activities(Baseline, 6, and 18 months)
- Diabetes distress(Baseline, 6, and 18 months)
- Depressive symptoms(Baseline, 6, and 18 months)
- Self-Efficacy(Baseline, 6, and 18 months)
研究者
Xiaoxv Yin, PhD
Director of the office of social science and health management
Huazhong University of Science and Technology