Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program

NCT06813482 | Completed

• 1 other identifier: 321/21
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 2.Do DeCR intervention patients have similar hospital utilization outcomes compared to traditional face-to-face cardiac rehabilitation patients?
3. 3.Does the DeCR intervention have associated improvements in healthy lifestyle behaviors and clinical risk factors?
4. 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. 5.Is the DeCR intervention cost effective?

Conditions

Heart Disease; Chronic Disease; Cardiovascular Disease Prevention

Keywords

telerehabilitation; cardiac rehabilitation; Digital health

Outcome Measures

Primary Outcomes (3)

• Hospital utilization

  All cause rehospitalizations, and hospital bed-days

  30-day, 90-day and 12-month post discharge

• Hospital utilization

  Cardiac related rehospitalizations, and hospital bed-days

  30-day, 90-day and 12-month post discharge

• Mortality

  All cause Mortality

  30-days and 12-month post discharge

Secondary Outcomes (10)

• Blood pressure

  At completion of the intervention at 8 weeks.

• Body mass index

  At completion of the intervention at 8 weeks.

• Diet

  At completion of the intervention at 8 weeks

• Alcohol intake - average number of standard alcoholic drinks consumed per week

  At completion of the intervention at 8 weeks

• Physical activity

  At completion of the intervention at 8 weeks

Other Outcomes (3)

• Mobile app engagement for tasks set

  At completion of the intervention at 8 weeks.

• Medication engagement via the app

  At completion of the intervention at 8 weeks.

• Overall mobile app engagement

  At completion of the intervention at 8 weeks.

Study Arms (3)

DeCR

Heart Health at Home - Digitally enabled cardiac rehabilitation

Behavioral: Digitally enabled cardiac rehabilitation

F2F-CR

Traditional Face-to-Face Cardiac Rehabilitation

Behavioral: F2F-CR

Usual Care

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

Behavioral: Usual Care Group

Interventions

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: 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.

DeCR

F2F-CR BEHAVIORAL

Traditional Face-to-face cardiac rehabilitation

F2F-CR

Usual Care Group BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Privately insured Australian patients, residing in any State or Territory in Australia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead
• University of Melbourne: collaborator
• Medibank: collaborator

Study Sites (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

Related Publications (10)

• 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.

  PMID: 38832727 BACKGROUND

• Kotseva 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.

  PMID: 29873511 BACKGROUND

• Ades 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.

  PMID: 27855953 BACKGROUND

• Woodruffe 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.

  PMID: 25637253 BACKGROUND

• Braver 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.

  PMID: 38938339 BACKGROUND

• Varnfield 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.

  PMID: 24973083 BACKGROUND

• Golbus 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.

  PMID: 37272365 BACKGROUND

• Turk-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.

  PMID: 25027487 BACKGROUND

• Dibben 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.

  PMID: 34741536 BACKGROUND

• Visseren 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.

  PMID: 34458905 BACKGROUND

Related Links

• Baker Institute study website

MeSH Terms

Conditions

Heart Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melinda J Carrington

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 7, 2025
• Study Start: November 30, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Following publication; no end date
• Access Criteria: Access subject to approvals by Principal Investigator and study Contributors

Locations

AU (1)