Text Messaging and Cardiovascular Health in Diabetes Mellitus: A Randomized, Controlled Clinical Trial (TEACH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 819
- 试验地点
- 1
- 主要终点
- Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model.
研究概览
简要总结
The purpose of the study of the proposed randomized trial is to evaluate the effectiveness of automated mobile phone text message-based intervention in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes.
详细描述
Most patients with diabetes have multiple risk factors, such as obesity, hypertension, and dyslipidemia, or with arteriosclerotic cardiovascular disease (ASCVD). The purpose of the study of the proposed randomized trial will examine the effect of health text messages in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes. This study is a multicenter prospective, randomized, controlled clinical trial. The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care. The messages will target lifestyle recommendation, glucose control, blood pressure control, healthy eating, medication adherence, physical activity and smoking cessation. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. The primary outcome is the combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. The Secondary outcome includes the net change of CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol), and the proportion of participants with HbA1C <7% (<7.5% if with clinical CVD), BP<140/90 mm Hg, and LDL-cholesterol <100 mg/dL, and net change in estimated 10-year risk of CHD and CVD. The primary outcome and secondary outcome will be measured at month 3, 6, and 12 visits.
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 (Investigator, Outcomes Assessor)
盲法说明
The study is a two-arm, parallel, randomized clinical trial. The primary outcome and secondary outcomes was measured by blinded assessors throughout the study period.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 years and over
- •Patients with poorly controlled type 2 diabetes who are undergoing routine treatment (defined as HbA1c≥ 7% or HbA1c≥7.5% if combined with clinical cardiovascular disease) have at least one risk factor for other cardiovascular disease (SBP≥140 mmHg and/or DBP≥90 mmHg and/or low density lipoprotein cholesterol≥100mg/dL) or clinical atherosclerotic cardiovascular disease (acute coronary syndrome, ischemic stroke transient ischemic attack or peripheral arterial disease)
- •Participants can provide written informed consent.
- •Participants required access to a smartphone, and be able to receive and read text message.
排除标准
- •Participants were in functional New York Heart Association class III or IV, and were on haemodialysis;
- •Pregnant women or women planning to become pregnant
- •Participants cannot be followed up for 12 months (due to health status or migration)
- •Participants cannot provide written informed consent.
结局指标
主要结局
Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model.
时间窗: 12 months
次要结局
- Change in glucose level measured by HbA1C level(12 months)
- Change in Systolic blood pressure level(12 months)
- Change in LDL-cholesterol level(12 months)
- The proportion achieving levels of blood pressure <140/90 mm Hg(12 months)
- Change in Framingham Risk Score(12 months)
- The proportion achieving levels of Hba1c < 7% (< 7.5% if combined with cardiovascular disease)(12 months)
- Change in ACC/AHA Risk Score of CVD(12 months)
- The proportion achieving levels of LDL-cholesterol <100 mg/dL(12 months)
研究者
Huijie Zhang
Clinical Professor
Nanfang Hospital, Southern Medical University