NCT04192409

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,038 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Coronary Artery Bypass
• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Smartphone Application	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-04-01
• Completion: 2022-06-30
• First posted: 2019-12-10
• Last updated: 2023-01-19

Locations

1 site across 1 country: China