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

Coronary Artery Disease Clinical Trial

— GUIDEME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192409
• Other study ID #: FW2019-1151
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1038
• Est. completion date: June 30, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Science,Fuwai Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence of all-cause death	We will measure the incidence of all-cause death at 6 months.	6 months
Secondary	The incidence of major adverse cardiovascular events(MACE)	We will measure the incidence of major adverse cardiovascular events(MACE) at 6 months.	6 months
Secondary	EQ-5D	We will measure the change in EQ-5D health survey 6 months postoperatively.	6 months
Secondary	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
Secondary	Status of the graft vessels	We will measure the status of the graft vessels by coronary CT angiography at 6 months.	6 months
Secondary	blood pressure	We will document blood pressure at 6 months postoperatively.	6 months
Secondary	blood glucose	We will document blood glucose at 6 months postoperatively.	6 months
Secondary	low density lipoprotein	We will document low density lipoprotein at 6 months postoperatively.	6 months