Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management

Conditions
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Coronary Artery Disease, Coronary Artery Bypass, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Smartphone Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnose with type 2 diabetes before this administration; Postoperative patients undergoing CABG in this hospitalization; Exclusion Criteria: Die before discharge; Disability of reading, vision or hearing which leads to disability of using smartphone; Cognitive communication impairments or communication disorder; Unable to use smartphone.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention-Smartphone Application<br>Patients will install a smartphone application that custom-developed for the study and learn to use it with the help of researchers. The application will have the following functions: 1) providing health education information about glycemic control, postoperative management and important of drug compliance; 2) providing alert & record service on patients' DM and CAD medication treatment; 3) aiding patients to conduct self-evaluate by providing questionnaire about patients' recent basic health parameters on times. The information will be interpreted automatically by application and brief feedback will be provided to patients; 4) recording patients' fasting plasma glucose value that input by patients and generate a recent glycemic control report. | Behavioral: Smartphone Application<br>* 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.<br>|
| No Intervention: Control<br>Patients will receive no additional intervention from researchers except the usual care provided by hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose level measured by HbA1C level | We will measured the change in glucose level from baseline to 6 months. | Baseline; 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of all-cause death | We will measure the incidence of all-cause death at 6 months. | 6 months | 
| The incidence of major adverse cardiovascular events(MACE) | We will measure the incidence of major adverse cardiovascular events(MACE) at 6 months. | 6 months | 
| EQ-5D | We will measure the change in EQ-5D health survey 6 months postoperatively. | 6 months | 
| Medication adherence | Medication adherence is collected by a self-reported questionnaire including two questions: 1) have you ever forget to take your medication? If so, how often will you describe? 2) have you ceased to take any medication? If so, does it ceased as prescribed by doctor? Question 1 has four option if patients choose yes: 1) I hardly forget to take my medicine; 2) I forget to take my medicine monthly; 3) I forget to take my medicine every week; 4) I hardly take any medicine. | 6 months | 
| Status of the graft vessels | We will measure the status of the graft vessels by coronary CT angiography at 6 months. | 6 months | 
| blood pressure | We will document blood pressure at 6 months postoperatively. | 6 months | 
| blood glucose | We will document blood glucose at 6 months postoperatively. | 6 months | 
| low density lipoprotein | We will document low density lipoprotein at 6 months postoperatively. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Coronary Artery Bypass Grafting, Diabetes Mellitus, Smartphone Application, Postoperative Management