Viewing Study NCT04966117



Ignite Creation Date: 2024-05-06 @ 4:22 PM
Last Modification Date: 2024-10-26 @ 2:09 PM
Study NCT ID: NCT04966117
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-10-03
First Post: 2021-06-29

Brief Title: Risk-guided Disease Management in Coronary Artery Disease
Sponsor: Baker Heart and Diabetes Institute
Organization: Baker Heart and Diabetes Institute

Study Overview

Official Title: A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease Risk-Guided CAD
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Risk-CAD
Brief Summary: Coronary artery disease CAD is the number one killer of Australians with a high risk for a recurrent events 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 professionalsproviders 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
Detailed 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None