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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04192409
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences, Fuwai Hospital
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Bypass Diabetes Mellitus Behavioral: Smartphone Application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The incidence of all-cause death [ Time Frame: 6 months ]
    We will measure the incidence of all-cause death at 6 months.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Yangwu Song, MD +8618800161699 18800161699@163.com
Contact: Yifeng Nan dr.nan@foxmail.com

Locations
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China, Beijing
Chinese Academy of Medical Science,Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Yangwu Song, MD    +86 18800161699    18800161699@163.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Wei Feng, MD, PhD Chinese Academy of Medical Sciences, Fuwai Hospital

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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT04192409    
Other Study ID Numbers: FW2019-1151
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Center for Cardiovascular Diseases:
Coronary Artery Disease
Coronary Artery Bypass Grafting
Diabetes Mellitus
Smartphone Application
Postoperative Management
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases