Risk-guided Disease Management in Coronary Artery Disease

NCT04966117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

Risk-Guided DMP

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.

BEHAVIORAL

Usual Care

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.

Sponsors & Collaborators

  • Heartwest

    collaborator UNKNOWN
  • University of Melbourne

    collaborator OTHER
  • Queen's University, Belfast

    collaborator OTHER
  • Western Health

    collaborator UNKNOWN
  • Baker Heart and Diabetes Institute

    lead OTHER

Principal Investigators

  • Melinda J Carrington, PhD · Baker Heart and Diabetes Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-17
Primary Completion
2024-10-10
Completion
2025-07-10

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04966117 on ClinicalTrials.gov