Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management
NCT ID: NCT04192409
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1038 participants
INTERVENTIONAL
2020-01-01
2022-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention-Smartphone Application
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.
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.
Control
Patients will receive no additional intervention from researchers except the usual care provided by hospital.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Postoperative patients undergoing CABG in this hospitalization;
Exclusion Criteria
* Disability of reading, vision or hearing which leads to disability of using smartphone;
* Cognitive communication impairments or communication disorder;
* Unable to use smartphone.
18 Years
80 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Wei Feng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Chinese Academy of Medical Science,Fuwai Hospital
Beijing, Beijing Municipality, China
Countries
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References
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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.
Other Identifiers
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FW2019-1151
Identifier Type: -
Identifier Source: org_study_id
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