Skip to main content
OpenTrials
Completed

NCT Number: NCT06813482

Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

About this study

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:

  • Self-reported demographic information (assessed prior to the intervention) - age, sex, ethnicity, employment, living situation, location and geographic based socioeconomic status.
  • 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).
  • 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).
  • 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'.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Digitally enabled cardiac rehabilitation

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:

  • 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.
  • 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

Behavioral

Traditional Face-to-face cardiac rehabilitation

Usual Care Group

Behavioral

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

Primary outcomes

  1. Hospital utilization

    Time frame: 30-day, 90-day and 12-month post discharge

    All cause rehospitalizations, and hospital bed-days

  2. Hospital utilization

    Time frame: 30-day, 90-day and 12-month post discharge

    Cardiac related rehospitalizations, and hospital bed-days

  3. Mortality

    Time frame: 30-days and 12-month post discharge

    All cause Mortality

Secondary outcomes

  1. Blood pressure

    Time frame: At completion of the intervention at 8 weeks.

    Pre vs post change in systolic and diastolic blood pressure (mmHg)

  2. Body mass index

    Time frame: At completion of the intervention at 8 weeks.

    Pre vs post change in body mass index (BMI)

  3. Diet

    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.

  4. Alcohol intake - 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 standard alcoholic drinks consumed per week

  5. Physical activity

    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).

  6. Patient Activation Measure

    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.

  7. Functional capacity - Duke Activity Status Index

    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.

  8. Kessler Psychological Distress Scale

    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.

  9. Quality of life - EuroQol-5 Dimension questionnaire

    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".

  10. Medication adherence - 4-item Morisky Medication Adherence Scale

    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.

Other outcomes

  1. Mobile app engagement for tasks set

    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

  2. Medication engagement via the app

    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

  3. Overall mobile app engagement

    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.

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Collaborators

  • Medibank
  • University of Melbourne

Registry information

Official study title

Heart Health at Home - Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.