Heart DiseaseNCT06813482
Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program
An observational study of Heart Disease and Chronic Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Chronic Disease, Cardiovascular Disease Prevention
- What is being tested?
- Digitally enabled cardiac rehabilitation and F2F-CR
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 172 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Nov 2019to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Privately insured Australian patients, residing in any State or Territory in Australia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
About this study
Official title: Heart Health at Home - 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.
Read more
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:
- Does the DeCR intervention group have associated reductions in hospital readmissions, total hospital bed days, and mortality compared to the usual care group?
- Do DeCR intervention patients have similar hospital utilization outcomes compared to traditional face-to-face cardiac rehabilitation patients?
- Does the DeCR intervention have associated improvements in healthy lifestyle behaviors and clinical risk factors?
- Does the DeCR intervention increase uptake and engagement to cardiac rehabilitation and what are participants' and cardiac nurses' experiences and perceptions of the program?
- 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.
Read the detailed 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:
- 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'.
- Being tested
- Digitally enabled cardiac rehabilitation, F2F-CR, Usual Care Group
- Keywords
- telerehabilitation, cardiac rehabilitation, Digital health
- Medical subject headings
- Heart Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally enabled cardiac rehabilitationBehavioural
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-CRBehavioural
Traditional Face-to-face cardiac rehabilitation
Usual Care GroupBehavioural
Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| DeCR | Heart Health at Home - Digitally enabled cardiac rehabilitation Receives: Behavioral: Digitally enabled cardiac rehabilitation | |
| F2F-CR | Traditional Face-to-Face Cardiac Rehabilitation Receives: Behavioral: F2F-CR | |
| Usual Care | Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital utilization
All cause rehospitalizations, and hospital bed-days
Measured: 30-day, 90-day and 12-month post discharge
Hospital utilization
Cardiac related rehospitalizations, and hospital bed-days
Measured: 30-day, 90-day and 12-month post discharge
Mortality
All cause Mortality
Measured: 30-days and 12-month post discharge
Secondary outcomes (10)
Blood pressure
Pre vs post change in systolic and diastolic blood pressure (mmHg)
Measured: At completion of the intervention at 8 weeks.
Body mass index
Pre vs post change in body mass index (BMI)
Measured: At completion of the intervention at 8 weeks.
Diet
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.
Measured: At completion of the intervention at 8 weeks
Alcohol intake - average number of standard alcoholic drinks consumed per week
Pre vs post change in the average number of standard alcoholic drinks consumed per week
Measured: At completion of the intervention at 8 weeks
Physical activity
Pre vs post change in the average number of minutes of physical activity completed per week (minutes per week).
Measured: At completion of the intervention at 8 weeks
Patient Activation Measure
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.
Measured: At completion of the intervention at 8 weeks
Functional capacity - Duke Activity Status Index
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.
Measured: At completion of the intervention at 8 weeks
Kessler Psychological Distress Scale
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.
Measured: At completion of the intervention at 8 weeks.
Quality of life - EuroQol-5 Dimension questionnaire
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".
Measured: At completion of the intervention at 8 weeks.
Medication adherence - 4-item Morisky Medication Adherence Scale
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.
Measured: At completion of the intervention at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start30 Nov 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, Medibank
- Responsible party
- Sponsor
- Investigators
- Melinda J Carrington, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813482
- Sponsor's protocol ID
- 321/21
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After de-identification and underlying published results, the data underlying the study may be shared on reasonable request to the Principal Investigator and approval by the Contributors. The deidentified data may only be available to researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Principal Investigator and study Contributors.
Publications
Blacher J, Olie V, Gabet A, Cinaud A, Tuppin P, Iliou MC, Grave C. Two-year prognosis and cardiovascular disease prevention after acute coronary syndrome: the role of cardiac rehabilitation-a French nationwide study. Eur J Prev Cardiol. 2024 Nov 18;31(16):1939-1947. doi: 10.1093/eurjpc/zwae194.
PubMed 38832727Kotseva K, Wood D, De Bacquer D; EUROASPIRE investigators. Determinants of participation and risk factor control according to attendance in cardiac rehabilitation programmes in coronary patients in Europe: EUROASPIRE IV survey. Eur J Prev Cardiol. 2018 Aug;25(12):1242-1251. doi: 10.1177/2047487318781359. Epub 2018 Jun 6.
PubMed 29873511Ades PA, Keteyian SJ, Wright JS, Hamm LF, Lui K, Newlin K, Shepard DS, Thomas RJ. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clin Proc. 2017 Feb;92(2):234-242. doi: 10.1016/j.mayocp.2016.10.014. Epub 2016 Nov 15.
PubMed 27855953Woodruffe S, Neubeck L, Clark RA, Gray K, Ferry C, Finan J, Sanderson S, Briffa TG. Australian Cardiovascular Health and Rehabilitation Association (ACRA) core components of cardiovascular disease secondary prevention and cardiac rehabilitation 2014. Heart Lung Circ. 2015 May;24(5):430-41. doi: 10.1016/j.hlc.2014.12.008. Epub 2015 Jan 12.
PubMed 25637253Braver J, Marwick TH, Oldenburg B, Issaka A, Carrington MJ. Digital Health Programs to Reduce Readmissions in Coronary Artery Disease: A Systematic Review and Meta-Analysis. JACC Adv. 2023 Sep 7;2(8):100591. doi: 10.1016/j.jacadv.2023.100591. eCollection 2023 Oct.
PubMed 38938339Varnfield M, Karunanithi M, Lee CK, Honeyman E, Arnold D, Ding H, Smith C, Walters DL. Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart. 2014 Nov;100(22):1770-9. doi: 10.1136/heartjnl-2014-305783. Epub 2014 Jun 27.
PubMed 24973083Golbus JR, Lopez-Jimenez F, Barac A, Cornwell WK 3rd, Dunn P, Forman DE, Martin SS, Schorr EN, Supervia M; Exercise, Cardiac Rehabilitation and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. Circulation. 2023 Jul 4;148(1):95-107. doi: 10.1161/CIR.0000000000001150. Epub 2023 Jun 5.
PubMed 37272365Turk-Adawi K, Sarrafzadegan N, Grace SL. Global availability of cardiac rehabilitation. Nat Rev Cardiol. 2014 Oct;11(10):586-96. doi: 10.1038/nrcardio.2014.98. Epub 2014 Jul 15.
PubMed 25027487Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
PubMed 34741536Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Health at Home - Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program
- ClinicalTrials.gov ID
- NCT06813482
- Acronym / sponsor ID
- 321/21
- Keywords
- telerehabilitation, cardiac rehabilitation, Digital health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Collaborators
- University of Melbourne, Medibank
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the DeCR intervention group have associated reductions in hospital readmissions, total hospital bed days, and mortality compared to the usual care group?
- Do DeCR intervention patients have similar hospital utilization outcomes compared to traditional face-to-face cardiac rehabilitation patients?
- Does the DeCR intervention have associated improvements in healthy lifestyle behaviors and clinical risk factors?
- Does the DeCR intervention increase uptake and engagement to cardiac rehabilitation and what are participants' and cardiac nurses' experiences and perceptions of the program?
- 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.
Detailed 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:
- 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'.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DeCR | – | Behavioral: Digitally enabled cardiac rehabilitationHeart Health at Home - Digitally enabled cardiac rehabilitation |
| F2F-CR | – | Behavioral: F2F-CRTraditional Face-to-Face Cardiac Rehabilitation |
| Usual Care | – | Behavioral: Usual Care GroupUsual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Privately insured Australian patients, residing in any State or Territory in Australia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitally enabled cardiac rehabilitationThe 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. | Behavioural | DeCR |
| F2F-CRTraditional Face-to-face cardiac rehabilitation | Behavioural | F2F-CR |
| Usual Care GroupUsual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program | Behavioural | Usual Care |
Primary outcome
Hospital utilization
Time frame: 30-day, 90-day and 12-month post discharge
All cause rehospitalizations, and hospital bed-days
Hospital utilization
Time frame: 30-day, 90-day and 12-month post discharge
Cardiac related rehospitalizations, and hospital bed-days
Mortality
Time frame: 30-days and 12-month post discharge
All cause Mortality
10 secondary outcomes
Blood pressure
Time frame: At completion of the intervention at 8 weeks.
Body mass index
Time frame: At completion of the intervention at 8 weeks.
Diet
Time frame: At completion of the intervention at 8 weeks
Alcohol intake - average number of standard alcoholic drinks consumed per week
Time frame: At completion of the intervention at 8 weeks
Physical activity
Time frame: At completion of the intervention at 8 weeks
Patient Activation Measure
Time frame: At completion of the intervention at 8 weeks
Functional capacity - Duke Activity Status Index
Time frame: At completion of the intervention at 8 weeks
Kessler Psychological Distress Scale
Time frame: At completion of the intervention at 8 weeks.
Quality of life - EuroQol-5 Dimension questionnaire
Time frame: At completion of the intervention at 8 weeks.
Medication adherence - 4-item Morisky Medication Adherence Scale
Time frame: At completion of the intervention at 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 38832727Blacher J, Olie V, Gabet A, Cinaud A, Tuppin P, Iliou MC, Grave C. Two-year prognosis and cardiovascular disease prevention after acute coronary syndrome: the role of cardiac rehabilitation-a French nationwide study. Eur J Prev Cardiol. 2024 Nov 18;31(16):1939-1947. doi: 10.1093/eurjpc/zwae194.
- Background: PubMed 29873511Kotseva K, Wood D, De Bacquer D; EUROASPIRE investigators. Determinants of participation and risk factor control according to attendance in cardiac rehabilitation programmes in coronary patients in Europe: EUROASPIRE IV survey. Eur J Prev Cardiol. 2018 Aug;25(12):1242-1251. doi: 10.1177/2047487318781359. Epub 2018 Jun 6.
- Background: PubMed 27855953Ades PA, Keteyian SJ, Wright JS, Hamm LF, Lui K, Newlin K, Shepard DS, Thomas RJ. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clin Proc. 2017 Feb;92(2):234-242. doi: 10.1016/j.mayocp.2016.10.014. Epub 2016 Nov 15.
- Background: PubMed 25637253Woodruffe S, Neubeck L, Clark RA, Gray K, Ferry C, Finan J, Sanderson S, Briffa TG. Australian Cardiovascular Health and Rehabilitation Association (ACRA) core components of cardiovascular disease secondary prevention and cardiac rehabilitation 2014. Heart Lung Circ. 2015 May;24(5):430-41. doi: 10.1016/j.hlc.2014.12.008. Epub 2015 Jan 12.
- Background: PubMed 38938339Braver J, Marwick TH, Oldenburg B, Issaka A, Carrington MJ. Digital Health Programs to Reduce Readmissions in Coronary Artery Disease: A Systematic Review and Meta-Analysis. JACC Adv. 2023 Sep 7;2(8):100591. doi: 10.1016/j.jacadv.2023.100591. eCollection 2023 Oct.
- Background: PubMed 24973083Varnfield M, Karunanithi M, Lee CK, Honeyman E, Arnold D, Ding H, Smith C, Walters DL. Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart. 2014 Nov;100(22):1770-9. doi: 10.1136/heartjnl-2014-305783. Epub 2014 Jun 27.
- Background: PubMed 37272365Golbus JR, Lopez-Jimenez F, Barac A, Cornwell WK 3rd, Dunn P, Forman DE, Martin SS, Schorr EN, Supervia M; Exercise, Cardiac Rehabilitation and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. Circulation. 2023 Jul 4;148(1):95-107. doi: 10.1161/CIR.0000000000001150. Epub 2023 Jun 5.
- Background: PubMed 25027487Turk-Adawi K, Sarrafzadegan N, Grace SL. Global availability of cardiac rehabilitation. Nat Rev Cardiol. 2014 Oct;11(10):586-96. doi: 10.1038/nrcardio.2014.98. Epub 2014 Jul 15.
- Background: PubMed 34741536Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
- Background: PubMed 34458905Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
- Baker Institute study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After de-identification and underlying published results, the data underlying the study may be shared on reasonable request to the Principal Investigator and approval by the Contributors. The deidentified data may only be available to researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Principal Investigator and study Contributors.
Related trials for Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda J Carrington principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease and Chronic Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital utilization (time frame: 30-day, 90-day and 12-month post discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813482, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.