Text Messaging and Cardiovascular Health in Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Text messaging
Intervention type(s): Behavioral
Intervention description(s): Intervention-Text messaging: Participants will receive regular text messages for 12 months. Each participant will receive 6 text messages per week. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week.
Control: The control group will receive the usual care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; cardiovascular disease; text message