Clinical trial NCT03565978: Cardiac Care Solution for Coronary Disease Follow up
Official title: Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Segment Elevation Myocardial Infarction
Non-ST Segment Elevation Myocardial Infarction
Unstable Angina
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Philips Electronics Nederland B.V. acting through Philips CTO organization
First posted: 2018-06-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with CAD, including either condition below: once diagnosed with myocardial infarction; or once accepted coronary artery interventional therapy;
* Participants willing to use self-management solution and complying with follow-up plan;
* At point of enrollment, the patients should be at least (\>=18) years
* Basic reading skills (Chinese)

Exclusion Criteria:

* Participants that are enrolled in another interventional clinical trial
* Participants who refuse to sign informed consent or withdraw for specific reasons recorded
* Participants who have cognition disorder and unable to communicate normally
* Participants who cannot master basic mobile technology skills to operate a mobile application after training

Primary outcomes:
measure: Compliance for coronary heart disease secondary prevention at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Medication compliance at the 6, 12 months using the MMAS-8 (The eight-item Morisky Medication Adherence Scale)
timeFrame: 6 and 12 months
measure: Control rates of risk factors at the 6, 12 months
timeFrame: 6 and 12 months
measure: Quality of life at the 6, 12 months (EQ-5D simple score)
timeFrame: 6 and 12 months
measure: Quality of life at the 6, 12 months (EQ-5D Visual Analog Score)
timeFrame: 6 and 12 months
measure: Quality of life at the 6, 12 month (Seattle angina questionnaire)
timeFrame: 6 and 12 months
measure: MACE within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization with heart problem, unexpected revascularization)
timeFrame: 12 months
measure: Self-management behaviors evaluation at the 6, 12 months using a local questionnaire
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Division of Cardiology, Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Gong Y, Zheng B, Fan F, Yi T, Zheng Y, He P, Fang J, Jia J, Zhu Q, Jiang J, Huo Y. Effects on Adherence to a Mobile App-Based Self-management Digital Therapeutics Among Patients With Coronary Heart Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Feb 15;10(2):e32251. doi: 10.2196/32251.