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

NCT04192409 | Completed

• 1 other identifier: FW2019-1151
• Study Type: interventional
• Target: 1,038
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass; Diabetes Mellitus

Keywords

Coronary Artery Disease; Coronary Artery Bypass Grafting; Diabetes Mellitus; Smartphone Application; Postoperative Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The incidence of all-cause death

  6 months

• The incidence of major adverse cardiovascular events(MACE)

  6 months

• EQ-5D

  6 months

• Medication adherence

  6 months

• Status of the graft vessels

  6 months

Study Arms (2)

Intervention-Smartphone Application

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients will receive no additional intervention from researchers except the usual care provided by hospital.

Interventions

Smartphone Application BEHAVIORAL

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.

Intervention-Smartphone Application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnose with type 2 diabetes before this administration;
• Postoperative patients undergoing CABG in this hospitalization;

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Chinese Academy of Medical Science,Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• Song Y, Nan Y, Feng W. Glycaemic control using mobile-based intervention in patients with diabetes undergoing coronary artery bypass-study protocol for a randomized controlled trial. Trials. 2023 Sep 13;24(1):585. doi: 10.1186/s13063-023-07580-x.

  PMID: 37705074 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wei Feng, MD, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: December 10, 2019
• Study Start: January 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: June 30, 2022
• Last Updated: January 19, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)