Chinese Academy of Medical Science,Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
NCT Number: NCT04192409
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100037, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline; 6 months
We will measured the change in glucose level from baseline to 6 months.
Time frame: 6 months
We will measure the incidence of all-cause death at 6 months.
Time frame: 6 months
We will measure the incidence of major adverse cardiovascular events(MACE) at 6 months.
Time frame: 6 months
We will measure the change in EQ-5D health survey 6 months postoperatively.
Time frame: 6 months
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.
Time frame: 6 months
We will measure the status of the graft vessels by coronary CT angiography at 6 months.
Time frame: 6 months
We will document blood pressure at 6 months postoperatively.
Time frame: 6 months
We will document blood glucose at 6 months postoperatively.
Time frame: 6 months
We will document low density lipoprotein at 6 months postoperatively.
China National Center for Cardiovascular Diseases
Other Gov
Acronym: GUIDEME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06029517
Arterial Occlusive Diseases, Arteriosclerosis
Buffalo, New York, United States
View Trial DetailsNCT02520921
Acute Coronary Syndrome, Arterial Occlusive Diseases
Paris, France
View Trial DetailsNCT07238764
Arterial Occlusive Diseases, Arteriosclerosis
Saint Petersburg, Russia
View Trial DetailsNCT03973931
Adherence, Medication, Arrhythmias, Cardiac
Aurora, Colorado, United States
View Trial Details