Ignite Creation Date:
2024-05-06 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03565978
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2016-04-03
Brief Title:
Cardiac Care Solution for Coronary Disease Follow up
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAMA
Brief Summary:
This is a prospective randomized controlled trial The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the secondary prevention of Coronary Artery Disease CAD
Detailed Description:
The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the population of cardiovascular CVD patients who were discharged from the hospital The objectives include two parts
Objective 1 Assess the feasibilities of using the solution by means of questionnaire
Objective 2 Evaluate the impacts of the solution in the secondary prevention of Coronary Artery Disease CAD
Primary outcome Compliance of coronary disease secondary prevention at 12 months
Secondary outcome Compliance of coronary disease secondary prevention at 6 months Self-management behavior evaluation at the 6 and 12 months Medication compliance at 6 and 12 months assessed by self-reporting questionnaire Control rates of risk factors at the 6 and 12 months serum LDL-C blood pressure fasting serum glucose quality of life at the 6 and 12 months EQ-5D Seattle angina questionnaire MACE Major Adverse Cardiac Event within 12 months death nonfatal myocardial infarction nonfatal stroke hospitalization for cardiac reason unplanned coronary revascularization
The study will be a two arm randomized control study The intervention group will use an application installed on a Pad besides standard outpatient follow up while the control group will receive standard outpatient follow up
Objective 1 Assess the feasibilities of using the solution by means of questionnaire
Objective 2 Evaluate the impacts of the solution in the secondary prevention of Coronary Artery Disease CAD
Primary outcome Compliance of coronary disease secondary prevention at 12 months
Secondary outcome Compliance of coronary disease secondary prevention at 6 months Self-management behavior evaluation at the 6 and 12 months Medication compliance at 6 and 12 months assessed by self-reporting questionnaire Control rates of risk factors at the 6 and 12 months serum LDL-C blood pressure fasting serum glucose quality of life at the 6 and 12 months EQ-5D Seattle angina questionnaire MACE Major Adverse Cardiac Event within 12 months death nonfatal myocardial infarction nonfatal stroke hospitalization for cardiac reason unplanned coronary revascularization
The study will be a two arm randomized control study The intervention group will use an application installed on a Pad besides standard outpatient follow up while the control group will receive standard outpatient follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None