Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management (GUIDEME)
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|ClinicalTrials.gov Identifier: NCT04192409|
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Coronary Artery Bypass Diabetes Mellitus||Behavioral: Smartphone Application||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2021|
Experimental: 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.
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.
No Intervention: Control
Patients will receive no additional intervention from researchers except the usual care provided by hospital.
- Change in glucose level measured by HbA1C level [ Time Frame: Baseline; 3months; 6 months ]We will measured the change in glucose level from baseline to 3 months and 6 months.
- The incidence of all-cause death [ Time Frame: 6 months ]We will measure the incidence of all-cause death at 6 months.
- The incidence of major adverse cardiovascular events(MACE) [ Time Frame: 6 months ]We will measure the incidence of major adverse cardiovascular events(MACE) at 6 months.
- SF-12 health survey [ Time Frame: Baseline; 3 months; 6 months ]We will measure the change in SF-12 health survey from baseline to 3 months and 6 months.
- Change in medication adherence [ Time Frame: Baseline; 3 months; 6 months ]We will measure the change in medication adherence using Medication possession ratio(MPR) defined as MPR=(number of days supply obtained excluding last refill)/ (number of days between first and last dispense date)×100 from baseline to 3 months and 6 months.
- Status of the graft vessels [ Time Frame: 6 months ]We will measure the status of the graft vessels by coronary CT angiography at 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192409
|Contact: Yangwu Song, MDemail@example.com|
|Contact: Yifeng Nanfirstname.lastname@example.org|
|Chinese Academy of Medical Science,Fuwai Hospital||Recruiting|
|Beijing, Beijing, China, 100037|
|Contact: Yangwu Song, MD +86 18800161699 email@example.com|
|Principal Investigator:||Wei Feng, MD, PhD||Chinese Academy of Medical Sciences, Fuwai Hospital|