Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program

Baker Heart and Diabetes Institute

Status: Completed

Conditions: Chronic Disease; Cardiovascular Disease Prevention; Heart Disease

Treatments: Behavioral: Usual Care Group; Behavioral: Digitally enabled cardiac rehabilitation; Behavioral: F2F-CR

Study type: Observational

Funder types: Other

Identifiers

NCT06813482

321/21

Details and patient eligibility

About

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.

Full description

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:

1. Self-reported demographic information (assessed prior to the intervention) - age, sex, ethnicity, employment, living situation, location and geographic based socioeconomic status.
2. Self reported risk factors - blood pressure using an automated device, height and weight, cigarette smoking, diet via a 9-item questionnaire developed by the investigators based on dietary guidelines, alcohol (total standard drinks per week) and physical activity (total minutes per week).
3. Self reported health and lifestyle behaviours - medication adherence via the 4-item Morisky Medication Adherence Scale (MMAS); functional capacity via the 12-item Duke Activity Status Index (DASI); psychological distress via the Kessler Psychological Distress Scale (K10); health status via the EuroQol 5-level questionnaire (EQ-5D-5L) (index value-Australia) and patient engagement in managing their health via the 13-item Patient Activation Measure (PAM).
4. App engagement tasks via the mobile app - daily blood pressure, using an automated device, stress levels, twice daily walking, weekly weight measurements and personalised education topics. Blood glucose concentration and alcohol intake will only be assessed if assigned to patients as a goal.

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'.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged over 18 years AND
2. hold private health insurance with Medibank at a level that includes cover for hospital treatment AND
3. Discharged from hospital with a cardiovascular diagnosis and/or procedure eligible for cardiac rehabilitation, as defined by the National Heart Foundation of Australia AND
4. be able to give written consent to participate

Exclusion criteria

1. Patients with heart failure; OR
2. Patients attending an alternate cardiac rehab program for the corresponding index event; OR
3. Patients who do not have access to a smart phone and internet connection

Trial design

172 participants in 3 patient groups

DeCR

Description:

Heart Health at Home - Digitally enabled cardiac rehabilitation

Treatment:

Behavioral: Digitally enabled cardiac rehabilitation

F2F-CR

Description:

Traditional Face-to-Face Cardiac Rehabilitation

Treatment:

Behavioral: F2F-CR

Usual Care

Description:

Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program

Treatment:

Behavioral: Usual Care Group