Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) Study
Condition: Coronary Artery Disease; Diabetes
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
Study type: Interventional

Summary: 
      The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to
      evaluate the effectiveness of automated mobile phone text message-based intervention for
      secondary prevention, including lifestyles modification, medication adherence improvement and
      risk factors control among coronary heart disease (CHD) patients with diabetes. The
      participants will be randomized into intervention and control groups in a 1:1 ratio. The
      intervention group will receive 6 pre-designed text messages per week in addition to usual
      care for 6 months, while the control group will receive usual care.
    

Detailed description: 
      Objective: This study aims to evaluate the effectiveness of automated mobile phone text
      message-based intervention for secondary prevention, including lifestyles modification,
      medication adherence improvement and risk factors control among CHD patients with diabetes.
      We hypothesized that an intervention using mobile phone text based education and reminder can
      improve risk factors control and medication adherence for CHD patients.

      Study design: The study is a two-arm, parallel, randomized clinical trial. Patients will be
      eligible if they have documented CHD defined as having history of myocardial infarction and
      percutaneous coronary intervention (PCI), have a history of diabetes mellitus, have the
      capability of reading and sending short message, and are able to provide informed consent.
      Patients will be excluded if they do not have an active mobile phone. The eligible
      participants will be allocated into intervention and control groups in a 1:1 ratio randomly.
      The intervention group will receive intervention of pre-designed text messages in addition to
      usual care, while the control group will receive usual care. All the participants will be
      followed up for 6 months.

      Study intervention: Participants in the intervention group will receive text messages for 6
      months as well as usual care. They will receive one general messages, one hypertension
      message, one glucose control message, one lifestyle message, one medication adherence message
      and one physical activity message per week.

      Outcome measures: The primary endpoint is the change in glycemic hemoglobin (HbA1C) as
      measured by central blood sample. Secondary endpoints include a change in proportion of
      patients achieving HbA1C<7%, body mass index (BMI), physical activity, medication adherence,
      systolic blood pressure, low-density lipoprotein cholesterol (LDL-C) and fasting blood
      glucose (FBG). Exploratory endpoints include long-term prognosis of the patients, such as
      death, nonfatal myocardial infarction, stroke and so on, as well as health status (SAQ and
      EQ-5D).

      Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values
      of analyzed endpoints between intervention group and control group will be compared according
      to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be
      conducted accordingly.
    

Intervention name(s): Text messaging
Intervention type(s): Behavioral
Intervention description(s): Patients will receive regular semi-personalized text messages for 6 months. Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am, 12noon, 4.00pm). They will receive one general messages, one hypertension message, one glucose control message, one lifestyle message, one medication adherence message and one physical activity message per week. Prior to study commencement, a bank of 270 messages have been developed based on guidelines and behavior change theory (BCT), and have underwent multidisciplinary expert review and qualitative review process.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Coronary artery disease; Diabetes; Text messages