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

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04192409
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
1,038
1
2
29.9
34.7

Study Details

Study Description

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
  • Behavioral: Smartphone Application
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1038 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 :
Jan 1, 2020
Actual Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in glucose level measured by HbA1C level [Baseline; 6 months]

    We will measured the change in glucose level from baseline to 6 months.

Secondary Outcome Measures

  1. The incidence of all-cause death [6 months]

    We will measure the incidence of all-cause death at 6 months.

  2. The incidence of major adverse cardiovascular events(MACE) [6 months]

    We will measure the incidence of major adverse cardiovascular events(MACE) at 6 months.

  3. EQ-5D [6 months]

    We will measure the change in EQ-5D health survey 6 months postoperatively.

  4. Medication adherence [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.

  5. Status of the graft vessels [6 months]

    We will measure the status of the graft vessels by coronary CT angiography at 6 months.

  6. blood pressure [6 months]

    We will document blood pressure at 6 months postoperatively.

  7. blood glucose [6 months]

    We will document blood glucose at 6 months postoperatively.

  8. low density lipoprotein [6 months]

    We will document low density lipoprotein at 6 months postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese Academy of Medical Science,Fuwai Hospital Beijing Beijing China 100037

Sponsors and Collaborators

  • China National Center for Cardiovascular Diseases
  • Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: Wei Feng, MD, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT04192409
Other Study ID Numbers:
  • FW2019-1151
First Posted:
Dec 10, 2019
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022