Risk-guided Disease Management in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— Risk-CAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04966117
• Other study ID #: 266/21
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Baker Heart and Diabetes Institute
• Contact: Melinda J Carrington, PhD
• Phone: +61 3 8532 1638
• Email: melinda.carrington[@]baker.edu.au
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 74 Years

Eligibility

Inclusion Criteria:

1. Aged between 30 to 74 years; AND

2. 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

3. Defined as higher risk (score >= 5) by PEGASUS-TIMI 54 criteria; AND

4. Eligible for Medicare.

Exclusion Criteria:

1. Inability to provide written informed consent; OR

2. Non-English speaking; OR

3. Inability to attend clinic visits; OR

4. Inability to engage with an app due to low technical literacy or lacking access to a smart phone or wi-fi; OR

5. Hospitalised with a primary diagnosis of heart failure; OR

6. eGFR <30 ml/min/1.73m2 (CKD stage 4 or stage 5); OR

7. Valve disease only; OR

8. Requiring palliative care; OR

9. Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy); OR

10. Participating in another study with a potential but unknown effect on outcome.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Risk-Guided DMP
Patients will be assigned a cardiac nurse to help manage their heart condition who will: develop a care plan and communicate with the patients' General Practitioner (GP) and cardiologist about management, particularly medications to help control risk factors. 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. 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. invite participation to a supervised 6-week group exercise program which will require using our on-site gym.
• 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.

Locations

Country	Name	City	State
Australia	Baker Heart and Diabetes Institute	Melbourne	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute	Heartwest, Queen's University, Belfast, University of Melbourne, Western Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mobile Health (mHealth) engagement	SmartCR (cardiac rehabilitation app) will be evaluated by measures of app engagement by quantifying data entry events and other indicators of program participation/week	12 months post discharge
Primary	Hospitalization or death	Unplanned all-cause hospital readmission or death	90 days post discharge
Secondary	Hospitalization or death	Short term unplanned all-cause hospital readmission or death	30 days post discharge
Secondary	Provider adherence to best practice guidelines	Increased prescription of lipid-lowering, anti-hypertensive (e.g. beta-blocker) and antiplatelet agents	12 months post discharge
Secondary	Risk factor control - lipids	Change in LDL-cholesterol (mmol/L)	12 months post discharge
Secondary	Risk factor control - blood pressure	Change in systolic and diastolic blood pressure (mmHg)	12 months post discharge
Secondary	Health well-being	Change in quality of life (via AQoL-8D total scores and 8 dimension scores)	12 months post discharge