Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management
Condition: Coronary Artery Disease; Coronary Artery Bypass; Diabetes Mellitus
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 and feasibility of using high-quality medication reminder
      smartphone application as a tool for secondary prevention in patients undergone CABG with DM,
      including the change in quality of life, medication adherence improvement and clinical
      outcome. The participants will be randomized into intervention and control groups in a 1:1
      ratio. The intervention group will receive information of secondary prevention of CHD and
      medication alarm using a specific smartphone application, while the control group will
      receive usual care.
    

Detailed description: 
      Objective: this study designed to evaluate the effectiveness and feasibility of using
      high-quality medication reminder smartphone application as a tool for secondary prevention in
      patients undergone CABG with DM, including the change in quality of life, medication
      adherence improvement and clinical outcome.

      Study design: the study is a two-arm, parallel, randomized clinical trial. Patients will be
      eligible if they have undergone CABG at this admission, have a history of diabetes mellitus,
      have the capability of reading and using smartphone application, and are able to provide
      informed consent. Patients will be excluded if they do not have smartphone. The eligible
      participants will be allocated into intervention and control groups in a 1:1 ratio randomly.
      The intervention group will receive intervention of smartphone application 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 install a specific costume
      smartphone application, which will send health education information, medication alarm and
      risk factor questionnaire at a fixed frequency to aid patients' self-evaluation, recording
      patients' recent fast plasma glucose value in addition to usual care.

      Outcome measures: The primary endpoint is the change in glycemic hemoglobin (HbA1C).
      Secondary endpoints include MACCE, medication adherence, quality of life and status of graft
      vessel.

      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): Smartphone Application
Intervention type(s): Behavioral
Intervention description(s): Patients will use a smartphone application contain the following functions: providing health education information about DM and CAD, reminding patients to take medicine on time by alarm, recording patients' recent fast plasma glucose value.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Coronary Artery Disease; Coronary Artery Bypass Grafting; Diabetes Mellitus; Smartphone Application; Postoperative Management