Risk-guided Disease Management in Coronary Artery Disease — Risk-CAD  

Coronary Artery Disease Clinical Trial

Official title: A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)

Status Recruiting

Clinical Trial Summary

Coronary artery disease (CAD) is the number one killer of Australians with a high risk for a recurrent event(s) and hospital readmission. Many of these readmissions can be prevented with better management to control the problem of CAD. A disease management program, led by nurses who interact with other health professionals/providers, can help with education and counselling, taking medications correctly and making healthy lifestyle changes for higher risk patients. Newer models of disease management programs make use of mobile devices (such as an "app") and telehealth (by phone or video call) to monitor and manage health which could facilitate CAD management. Therefore, the aim of this study is to test this type of disease management program (DMP) compared to standard care for reducing hospital readmissions or death in people with CAD who are at high risk of being readmitted. The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize that high-risk patients randomized to Risk-Guided CAD will have reduced hospital readmissions or death compared with those randomized to usual care.

Clinical Trial Description

The Investigators aim to test a nurse-led, technology-enabled model of health care delivery, called Risk-Guided DMP, to reduce readmissions following CAD, thereby enhancing recovery and survivorship.

The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize reduced hospital readmissions or death for high-risk patients randomized to Risk-Guided DMP compared to usual care.

Methods

This proposed study is an effectiveness and feasibility trial of a risk guided DMP to reduce hospital readmissions in CAD patients. The Investigators seek to do this by adopting innovative approaches to:

i) a community-based secondary prevention DMP, ii) supported by a novel m-Health app (SmartCR developed by CardiHab) to address components of a Cardiac Rehabilitation (CR) program, and iii) selection of higher risk patients for appropriate management by validated (PEGASUS-TIMI 54) criteria.

Patients aged 30-74 years who have been hospitalised with CAD will be recruited. Electronic medical records from Western Health (Sunshine or Footscray hospital) will be routinely screened (twice per week) to invite patients to participate. Heartwest cardiologists will also identify patients from their surgical lists.

Baseline measures will include clinical features (including severity and number of affected vessels) and biochemistry (troponin, B-type natriuretic protein, renal function) from medical records; patient self-reported socio-demographic features, cognitive function using the Montreal Cognitive Assessment as an important predictor of readmission, mental health via the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder (GAD-7) questionnaire and quality of life using the Assessment of Quality of Life (AQoL-8D) questionnaire. Exercise capacity will be quantified by peak oxygen uptake (VO2 peak) and cardiac function will be assessed via two-dimensional echocardiography.

Risk evaluation will be performed by PEGASUS-TIMI 54 criteria for selection of high risk patients [score ≥5] who have an increased risk of a secondary event. ;

Related Conditions & MeSH terms

• Chronic Disease
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Nurse's Role

• NCT number: NCT04966117
• Study type: Interventional
• Source: Baker Heart and Diabetes Institute
• Contact: Melinda J Carrington, PhD
• Phone: +61 3 8532 1638
• Email: melinda.carrington@baker.edu.au
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2021
• Completion date: December 31, 2024