Clinical trial NCT04192409: Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management
Official title: Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Bypass
Diabetes Mellitus
Keywords: Coronary Artery Disease
Coronary Artery Bypass Grafting
Diabetes Mellitus
Smartphone Application
Postoperative Management
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2019-12-10
Enrollment: 1038
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in glucose level measured by HbA1C level
timeFrame: Baseline; 6 months
Secondary outcomes:
measure: The incidence of all-cause death
timeFrame: 6 months
measure: The incidence of major adverse cardiovascular events(MACE)
timeFrame: 6 months
measure: EQ-5D
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Status of the graft vessels
timeFrame: 6 months
measure: blood pressure
timeFrame: 6 months
measure: blood glucose
timeFrame: 6 months
measure: low density lipoprotein
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Science,Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Wei Feng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: