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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06813482
Registration number
NCT06813482
Ethics application status
Date submitted
22/01/2025
Date registered
25/03/2025
Date last updated
25/03/2025
Titles & IDs
Public title
Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program
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Scientific title
Heart Health at Home - Real-World Evaluation of a Digitally Enabled Cardiac Rehabilitation Program
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Secondary ID [1]
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321/21
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Disease
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Chronic Disease
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Cardiovascular Disease Prevention
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
BEHAVIORAL - Digitally enabled cardiac rehabilitation
BEHAVIORAL - F2F-CR
BEHAVIORAL - Usual Care Group
DeCR - Heart Health at Home - Digitally enabled cardiac rehabilitation
F2F-CR - Traditional Face-to-Face Cardiac Rehabilitation
Usual Care - Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program
BEHAVIORAL: 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.
BEHAVIORAL: F2F-CR
Traditional Face-to-face cardiac rehabilitation
BEHAVIORAL: Usual Care Group
Usual Care - eligible for cardiac rehabilitation and who unlikely participated in any formal cardiac rehabilitation program
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hospital utilization
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Assessment method [1]
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All cause rehospitalizations, and hospital bed-days
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Timepoint [1]
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30-day, 90-day and 12-month post discharge
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Primary outcome [2]
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Hospital utilization
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Assessment method [2]
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Cardiac related rehospitalizations, and hospital bed-days
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Timepoint [2]
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30-day, 90-day and 12-month post discharge
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Primary outcome [3]
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Mortality
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Assessment method [3]
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All cause Mortality
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Timepoint [3]
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30-days and 12-month post discharge
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Secondary outcome [1]
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Blood pressure
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Assessment method [1]
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Pre vs post change in systolic and diastolic blood pressure (mmHg)
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Timepoint [1]
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At completion of the intervention at 8 weeks.
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Secondary outcome [2]
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Body mass index
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Assessment method [2]
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Pre vs post change in body mass index (BMI)
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Timepoint [2]
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At completion of the intervention at 8 weeks.
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Secondary outcome [3]
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Diet
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Assessment method [3]
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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.
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Timepoint [3]
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At completion of the intervention at 8 weeks
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Secondary outcome [4]
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Alcohol intake - average number of standard alcoholic drinks consumed per week
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Assessment method [4]
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Pre vs post change in the average number of standard alcoholic drinks consumed per week
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Timepoint [4]
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At completion of the intervention at 8 weeks
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Secondary outcome [5]
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Physical activity
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Assessment method [5]
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Pre vs post change in the average number of minutes of physical activity completed per week (minutes per week).
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Timepoint [5]
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At completion of the intervention at 8 weeks
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Secondary outcome [6]
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Patient Activation Measure
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Assessment method [6]
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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.
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Timepoint [6]
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At completion of the intervention at 8 weeks
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Secondary outcome [7]
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Functional capacity - Duke Activity Status Index
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Assessment method [7]
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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.
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Timepoint [7]
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At completion of the intervention at 8 weeks
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Secondary outcome [8]
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Kessler Psychological Distress Scale
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Assessment method [8]
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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.
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Timepoint [8]
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At completion of the intervention at 8 weeks.
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Secondary outcome [9]
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Quality of life - EuroQol-5 Dimension questionnaire
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Assessment method [9]
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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".
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Timepoint [9]
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At completion of the intervention at 8 weeks.
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Secondary outcome [10]
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Medication adherence - 4-item Morisky Medication Adherence Scale
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Assessment method [10]
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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.
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Timepoint [10]
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At completion of the intervention at 8 weeks.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2022
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Sample size
Target
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Accrual to date
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Final
172
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baker Heart and Diabetes Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Melbourne
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Medibank
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT06813482
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Trial related presentations / 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Erratum In: Eur Heart J. 2022 Nov 7;43(42):4468. doi: 10.1093/eurheartj/ehac458.
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Public notes
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Contacts
Principal investigator
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Melinda J Carrington
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Address
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Baker Heart and Diabetes Institute
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
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When will data be available (start and end dates)?
Following publication; no end date
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Available to whom?
Access subject to approvals by Principal Investigator and study Contributors
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://baker.edu.au/research/laboratories/preclinical-disease-prevention
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06813482
Download to PDF