Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004, Australia
NCT Number: NCT06813482
After a heart event or procedure, patients are encouraged to participate in a cardiac rehabilitation (CR) program to improve their health and reduce the risk of future problems. These programs have been shown to improve heart health and reduce hospital readmissions and deaths. However, many patients face challenges attending in-person CR programs, particularly those residing in regional or remote areas. As a result, many patients worldwide do not participate in CR.
Missing out on CR increases the risk of unplanned hospital visits. To overcome these challenges, digitally enabled cardiac rehabilitation programs provide an alternative. These programs use technology, such as mobile apps and telehealth, to deliver care remotely. Although these programs have the potential to make CR more accessible, there is still limited evidence about how well they work in real-world settings, including their impact on hospital visits and overall healthcare use.
Therefore, the goal of this real-world observational study is to evaluate if a digitally enabled and remotely delivered cardiac rehabilitation (DeCR) program, called Heart Health at Home, can improve risk factors and hospital utilization in adults who have experienced a heart event or undergone a heart procedure.
The questions it aims to answer are:
1. Does the DeCR intervention group have associated reductions in hospital readmissions, total hospital bed days, and mortality compared to the usual care group? 2. Do DeCR intervention patients have similar hospital utilization outcomes compared to traditional face-to-face cardiac rehabilitation patients? 3. Does the DeCR intervention have associated improvements in healthy lifestyle behaviors and clinical risk factors? 4. Does the DeCR intervention increase uptake and engagement to cardiac rehabilitation and what are participants' and cardiac nurses' experiences and perceptions of the program? 5. Is the DeCR intervention cost effective?
Researchers will compare participants receiving the DeCR intervention to those receiving traditional face-to-face cardiac rehabilitation and usual care to see if the program leads to better health outcomes and reduced healthcare utilization.
Participants will participate in an 8-week DeCR intervention entailing telehealth consultations with a cardiac rehabilitation nurse and they will use a mobile app, called SmartCR, to access education, remote monitoring and progress tracking.
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Notify Me18 year and older
All sexes
Observational
Melbourne, Victoria, 3004, Australia
The Investigators aim to assess a digitally enabled cardiac rehabilitation (DeCR) program, called Heart Health at Home, implemented in a real-world setting. The investigators will assess whether the program improves clinical outcomes, healthcare utilization, and program engagement for adults recovering from a cardiac event or procedure. The researchers hypothesize that the intervention would be associated with healthy lifestyle changes and improvements in clinical risk factors. They anticipate that Heart Health at Home would be associated with similar outcomes compared to traditional face-to-face cardiac rehabilitation and reduced hospital readmissions, hospital bed days and mortality compared to usual care.
Methods:
Investigators will evaluate this study via a prospective cohort study, to establish the associated benefits of the program on healthy lifestyle changes and improvements in clinical risk factors, followed by a propensity matched cohort study via analysis of private hospital claims data. Using propensity score matching methods, two concurrent control groups will be established to compare the DeCR group with patients who undertook either: 1) Face-to-Face cardiac rehabilitation (F2F-CR) or 2) usual care, following an index cardiac hospitalization. The investigators will assess the associated outcomes of DeCR participation on recurrent hospitalisations, days spent in hospital, mortality and cost outlays within 12 months post index admission. Additionally, the investigators will examine participants' and cardiac nurses' experiences and perceptions of the DeCR program.
Patients aged over 18 years, who hold private health insurance with a large Australian private health insurer and who have been hospitalized with a cardiovascular diagnosis and/or procedure eligible for cardiac rehabilitation will be recruited. Patients will be excluded if they; 1) have heart failure (due to the potential for more specialized care); 2) are attending an alternate cardiac rehabilitation program and; 3) do not have access to a smart phone and internet connection.
Baseline pre vs post measures will include:
Hospital admission data will be collected for all patient groups, for 12-months post discharge and include:
date of admission and discharge, index procedure information, sociodemographic data, cardiovascular disease condition, smoking history, past history of diabetes, chronic kidney disease and previous acute myocardial infarction, Charlson Comorbidity Index and risk of readmission via the PEGASUS-TIMI score - 'Prevention with Ticagrelor of Secondary Thrombotic events in high-risk Patients with Prior Acute Coronary Syndrome - Thrombolysis in Myocardial Infarction'.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention consists of an 8-week remotely delivered cardiac rehabilitation program. It includes an initial assessment during week 1, six weeks of participation in a digitally enabled cardiac rehabilitation (DeCR) program (weeks 2-7), and a final assessment in week 8. Participants will utilize a digital mobile application and receive weekly telehealth consultations with a cardiac nurse. The program is designed to facilitate behavior change and improve outcomes through the following modalities:
Traditional Face-to-face cardiac rehabilitation
Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program
Time frame: 30-day, 90-day and 12-month post discharge
All cause rehospitalizations, and hospital bed-days
Time frame: 30-day, 90-day and 12-month post discharge
Cardiac related rehospitalizations, and hospital bed-days
Time frame: 30-days and 12-month post discharge
All cause Mortality
Time frame: At completion of the intervention at 8 weeks.
Pre vs post change in systolic and diastolic blood pressure (mmHg)
Time frame: At completion of the intervention at 8 weeks.
Pre vs post change in body mass index (BMI)
Time frame: At completion of the intervention at 8 weeks
Pre vs post change in diet score (9-item questionnaire developed by the investigator working group based on dietary guidelines). Scores range from a lowest of 9 to a high of 28. Higher scores denote better diet quality.
Time frame: At completion of the intervention at 8 weeks
Pre vs post change in the average number of standard alcoholic drinks consumed per week
Time frame: At completion of the intervention at 8 weeks
Pre vs post change in the average number of minutes of physical activity completed per week (minutes per week).
Time frame: At completion of the intervention at 8 weeks
Pre vs post change in the Patient Activation Measure (PAM), which measures the knowledge, skills and confidence that a person has to manage their own wellbeing. Validated questionnaire comprising 13 questions. Score ranges from 0 to 100 with a higher score indicating greater patient activation. The minimum score is 0 and the maximum score is 100.
Time frame: At completion of the intervention at 8 weeks
Pre vs post change in the Duke Activity Status Index (DASI). Responses are summed to get a total score, which ranges from 0 to 58.2. Higher scores indicate higher functional capacity.
Time frame: At completion of the intervention at 8 weeks.
Pre vs post change in the Kessler Psychological Distress Scale (K10). Higher scores denote worse psychological distress. The maximum score is 50, indicating severe distress and the minimum score is 10, indicating no distress.
Time frame: At completion of the intervention at 8 weeks.
Pre vs post change in quality of life via the EQ-5D-5L index value-Australia. The maximum score represents "perfect health" and is denoted as "1", while the minimum score represents the worst possible health state and is "0".
Time frame: At completion of the intervention at 8 weeks.
Pre vs post change in the 4-item Morisky Medication Adherence Scale (MMAS). The maximum score is 4 and the minimum score is 0. A higher score indicates better adherence, while a lower score suggests poorer adherence.
Time frame: At completion of the intervention at 8 weeks.
Patient engagement for tasks set within the SmartCR app to be calculated by the number of tasks marked as completed, divided by the number of tasks assigned during the intervention period
Time frame: At completion of the intervention at 8 weeks.
Medication engagement via the app will be calculated by the number of medication reminders marked as taken or not taken, divided by the total number of medication reminders sent over the intervention period
Time frame: At completion of the intervention at 8 weeks.
A composite variable to assess overall app engagement will be created by combining responses to tasks assigned and medication reminders.
Baker Heart and Diabetes Institute
Other
Heart Health at Home - Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program
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