Risk-guided Disease Management in Coronary Artery Disease

NCT04966117 | Completed

• 1 other identifier: 266/21
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Chronic Disease; Nurse's Role

Keywords

Cardiac rehabilitation; Disease Management Program; Secondary Prevention; Rehospitalization; mHealth

Outcome Measures

Primary Outcomes (1)

• Hospitalization or death

  Unplanned all-cause hospital readmission or death

  90 days post discharge

Secondary Outcomes (5)

• Hospitalization or death

  30 days post discharge

• Provider adherence to best practice guidelines

  12 months post discharge

• Risk factor control - lipids

  12 months post discharge

• Risk factor control - blood pressure

  12 months post discharge

• Health well-being

  12 months post discharge

Other Outcomes (1)

• Mobile Health (mHealth) engagement

  12 months post discharge

Study Arms (2)

Risk-Guided DMP

EXPERIMENTAL

The intervention is a 12 month disease management program after hospital discharge for coronary artery disease that is overseen by a cardiac nurse.

Behavioral: Risk-Guided DMP

Usual Care

ACTIVE COMPARATOR

Usual care patients will receive standard cardiology care.

Behavioral: Usual Care

Interventions

Risk-Guided DMP BEHAVIORAL

Patients will be assigned a cardiac nurse to help manage their heart condition who will: 1. develop a care plan and communicate with the patients' General Practitioner (GP) and cardiologist about management, particularly medications to help control risk factors. 2. provide health coaching at pre-specified times over 12 months via telehealth (phone or video call) to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes. 3. facilitate cardiac rehabilitation via a smart phone or tablet app (called SmartCR). This app monitors health and physical activity, has prompted tasks to do and delivers education via video, audio and written articles. The information from this app can be used by the cardiac nurse during telehealth follow-up. 4. invite participation to a supervised 6-week group exercise program which will require using our on-site gym.

Risk-Guided DMP

Usual Care BEHAVIORAL

Usual care patients will receive standard cardiology care as scheduled that includes adherence to guideline-based care (medications and physical activity), education (self-care), a treatment plan to manage co-morbidities, early post-discharge follow-up/support and routine preventative care.

Usual Care

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 30 to 74 years; AND
• Hospitalised with CAD or other eligible cardiac procedure or condition including acute myocardial infarction (STEMI or NSTEMI), unstable angina, coronary artery bypass grafting or percutaneous coronary intervention; AND
• Defined as higher risk (score \>= 5) by PEGASUS-TIMI 54 criteria; AND
• Eligible for Medicare.

You may not qualify if:

• Inability to provide written informed consent; OR
• Non-English speaking; OR
• Inability to attend clinic visits; OR
• Inability to engage with an app due to low technical literacy or lacking access to a smart phone or wi-fi; OR
• Hospitalised with a primary diagnosis of heart failure; OR
• eGFR \<30 ml/min/1.73m2 (CKD stage 4 or stage 5); OR
• Valve disease only; OR
• Requiring palliative care; OR
• Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy); OR
• Participating in another study with a potential but unknown effect on outcome.

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead
• Heartwest: collaborator
• University of Melbourne: collaborator
• Queen's University, Belfast: collaborator
• Western Health: collaborator

Study Sites (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Chronic Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melinda J Carrington, PhD

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There are no other parties who will be masked in the clinical trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, open, parallel-group randomized controlled trial of a disease management program (intervention group) to reduce hospital readmissions or death compared to usual care (control group)

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 19, 2021
• Study Start: July 17, 2021
• Primary Completion: October 10, 2024
• Study Completion: July 10, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication; no end date.
• Access Criteria: Access subject to approvals by Principal Investigator.

Locations

AU (1)