Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-30

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

NCT06077201

Valvular Heart Disease

RECRUITING NA

Wearable Technology for Personalised Physical Activity Feedback in Cardiac Patients: a Feasibility Study

NCT05605015

Cardiovascular Diseases

COMPLETED EARLY_PHASE1

Home-Based Cardiac Rehabilitation for Patients With Heart Failure

NCT06479876

Heart Failure With Preserved Ejection Fraction Heart Failure With Reduced Ejection Fraction Cardiovascular Diseases

RECRUITING NA

Home-based Cardiac Rehabilitation in Heart Failure

NCT06349941

Heart Failure

RECRUITING PHASE3

Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

NCT06759805

Coronary Artery Disease Cardiac Rehabilitation Ethics +13 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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'.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Disease Chronic Disease Cardiovascular Disease Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DeCR

Heart Health at Home - Digitally enabled cardiac rehabilitation

Digitally enabled cardiac rehabilitation

Intervention Type BEHAVIORAL

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:

1. Telehealth - individualized coaching delivered via telephone by a cardiac nurse, to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes.
2. Mobile application (called SmartCR) and nurse web portal - for remote monitoring and personalized care planning. The app monitors health and physical activity, has prompted tasks and delivers education via video, audio and written articles.

F2F-CR

Traditional Face-to-Face Cardiac Rehabilitation

F2F-CR

Intervention Type BEHAVIORAL

Traditional Face-to-face cardiac rehabilitation

Usual Care

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

Usual Care Group

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digitally enabled cardiac rehabilitation

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:

1. Telehealth - individualized coaching delivered via telephone by a cardiac nurse, to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes.
2. Mobile application (called SmartCR) and nurse web portal - for remote monitoring and personalized care planning. The app monitors health and physical activity, has prompted tasks and delivers education via video, audio and written articles.

Intervention Type BEHAVIORAL

F2F-CR

Traditional Face-to-face cardiac rehabilitation

Intervention Type BEHAVIORAL

Usual Care Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No