Cardiovascular Health and Texting Messaging (CHAT) Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
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 without 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 without
      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
      PCI but without diabetes mellitus, have the capability of reading and sending short message,
      and are able to provide informed consent. Patients who do not have an active mobile phone
      will be excluded. 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 semi-personalized
      text messages for 6 months as well as usual care. Non-smokers will receive two general
      messages, two hypertension messages, one medication adherence message and one physical
      activity message per week. Smokers will receive one general message, two hypertension
      messages, one medication adherence message, one physical activity message and one smoking
      cessation message per week.

      Outcome measures: The primary endpoint is systolic blood pressure control. Secondary
      endpoints include a change in proportion of patients achieving a systolic blood
      pressure<140mm Hg, physical activity, medication adherence, smoking cessation, low-density
      lipoprotein cholesterol (LDL-C) and body mass index (BMI). Exploratory endpoints include
      long-term prognosis of the patients, such as death, non-fatal 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). Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week. Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week. Prior to study commencement, a bank of 280 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; Text messages; Blood pressure; Lifestyle; Risk factors