Coronary Artery DiseaseGUIDEMENCT04192409
Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management
A study testing Smartphone Application in people with Coronary Artery Disease and Coronary Artery Bypass, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass, Diabetes Mellitus
- What is being tested?
- Smartphone Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,038 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnose with type 2 diabetes before this administration;
- Postoperative patients undergoing CABG in this hospitalization;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Science,Fuwai Hospital
Beijing, Beijing Municipality, 100037
About this study
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.
Read the 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.
- Being tested
- Smartphone Application
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Diabetes Mellitus, Smartphone Application, Postoperative Management
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention-Smartphone Application | Experimental | 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. Receives: Behavioral: Smartphone Application |
| Control | No intervention | Patients will receive no additional intervention from researchers except the usual care provided by hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose level measured by HbA1C level
We will measured the change in glucose level from baseline to 6 months.
Measured: Baseline; 6 months
Secondary outcomes (8)
The incidence of all-cause death
We will measure the incidence of all-cause death at 6 months.
Measured: 6 months
The incidence of major adverse cardiovascular events(MACE)
We will measure the incidence of major adverse cardiovascular events(MACE) at 6 months.
Measured: 6 months
EQ-5D
We will measure the change in EQ-5D health survey 6 months postoperatively.
Measured: 6 months
Medication adherence
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.
Measured: 6 months
Status of the graft vessels
We will measure the status of the graft vessels by coronary CT angiography at 6 months.
Measured: 6 months
blood pressure
We will document blood pressure at 6 months postoperatively.
Measured: 6 months
blood glucose
We will document blood glucose at 6 months postoperatively.
Measured: 6 months
low density lipoprotein
We will document low density lipoprotein at 6 months postoperatively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jan 2020
- Primary completion1 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Feng, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192409
- Sponsor's protocol ID
- FW2019-1151
- Acronym
- GUIDEME
- Status last verified
- Jun 2022
- First submitted
- 30 Oct 2019
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37705074
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management
- ClinicalTrials.gov ID
- NCT04192409
- Acronym / sponsor ID
- GUIDEME / FW2019-1151
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Diabetes Mellitus, Smartphone Application, Postoperative Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-Smartphone Application | Experimental | Behavioral: Smartphone ApplicationPatients 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. |
| Control | No intervention | –Patients will receive no additional intervention from researchers except the usual care provided by hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnose with type 2 diabetes before this administration;
- Postoperative patients undergoing CABG in this hospitalization;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone ApplicationPatients 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. | Behavioural | Intervention-Smartphone Application |
Primary outcome
Change in glucose level measured by HbA1C level
Time frame: Baseline; 6 months
We will measured the change in glucose level from baseline to 6 months.
8 secondary outcomes
The incidence of all-cause death
Time frame: 6 months
The incidence of major adverse cardiovascular events(MACE)
Time frame: 6 months
EQ-5D
Time frame: 6 months
Medication adherence
Time frame: 6 months
Status of the graft vessels
Time frame: 6 months
blood pressure
Time frame: 6 months
blood glucose
Time frame: 6 months
low density lipoprotein
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 37705074Song 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Feng, MD, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application in people with Coronary Artery Disease and Coronary Artery Bypass, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose level measured by HbA1C level (time frame: Baseline; 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.