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Ambulatory monitor derived clinical measures for continuous assessment of cardiac rehabilitation patients

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NP Bidargaddi and A Sarela, "Ambulatory monitor derived clinical measures for continuous assessment of cardiac rehabilitation patients in community care model", Proc. 2nd Intl Conf. Pervasive …

NP Bidargaddi and A Sarela, "Ambulatory monitor derived clinical measures for continuous assessment of cardiac rehabilitation patients in community care model", Proc. 2nd Intl Conf. Pervasive Computing Technologies for Healthcare (Pervasive Health 2008), Tampere, Finland

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    • 1. Ambulatory monitor derived clinical measures for continuous assessment of cardiac rehabilitation patients Dr Niranjan P Bidargaddi Research Scientist 28 th August 2008 Patient centred health care
    • 2.
      • CSIRO
      • C ommonwealth S cientific and I ndustrial R esearch O rganization
      • www.csiro.au
    • 3. CSIRO Divisions and joint ventures
      • Agribusiness
        • Entomology
        • Livestock Industries
        • Plant Industry
        • Textile and Fibre Technology
        • Joint Ventures
        • Ensis
        • Food Science Australia
      • Sustainable Energy and Environment
        • Energy Technology
        • Land and Water
        • Marine and Atmospheric Research
        • Petroleum Resources
        • Sustainable Ecosystems
        • Australia Telescope National Facility
        • Exploration and Mining
        • Information and Communication Technologies Centre
        • Industrial Physics
        • Manufacturing and Infrastructure Technology
        • Mathematical and Information Sciences
        • Minerals
        • Molecular and Health Technologies
      • Information, Manufacturing and Minerals
      6,000+ staff at 57 sites in Australia and overseas $1 billion pa (600 million euro) Federal:70% External:30%
    • 4. CSIRO – 80 years of achievement
    • 5. ICT Centre Sites and Staff
      • ~250 staff
      • 28 PhD students
      • $48M pa
      Hobart ~30 Tasmanian ICT Centre Brisbane ~65 Autonomous Systems e-Health Research Centre Sydney ~ 125 Wireless Technologies Networking Technologies Information Engineering Autonomous Systems Canberra ~30 Information Engineering Networking Technologies
    • 6. e-Health Research Centre
      • Joint venture between CSIRO and the Queensland Government
      • Largest single-funded e-health research and development facility in the Southern Hemisphere
      • Aims to improve the quality and safety of healthcare for individuals and communities through an ICT research program focused on applied outcomes and active adoption by the health system
      • Multi-disciplinary team of over 50, including Research scientists, software engineers and PhD students
      • Core Projects:
        • Biomedical Imaging
        • Health Data Integration (HDI)
        • e-Health Metadata and Ontologies
        • Care Assessment Platform (CAP )
      • Several Partner and Affiliate Projects
    • 7. Care Assessment Platform project aims to develop and show evidence of IT/ telemonitoring tools in supporting Community Care teams focused on secondary prevention of Cardiovascular Diseases
    • 8. Outline
      • Cardiovascular diseases – Facts
      • Care model: Hospital based cardiac rehabilitation
        • Benefits and drawbacks
      • Alternative care models : Patient centric care models
      • Clinical Trial
        • Objectives
        • Trial setup
      • Clinically relevant measures for cardiac rehabilitation
      • Future works
    • 9.
      • Cardiovascular diseases- Facts
    • 10. Burden of Cardiovascular Diseases on Healthcare
      • Affects more than 3.5 million Australians.
      • 1.4 million people have reduced quality of life because of disability caused by the disease.
      • In 2004 CVD claimed the lives of almost 48,000 Australians; 35% of all deaths.
      CVD is one of the largest health problems in Australia, USA, and other western countries Source: National Heart Foundation of Australia
    • 11.
        • Care model: Benefits and drawbacks
    • 12. Prevention of Cardiovascular disease Cardiac events Healthy Lifestyle
      • Post-operation
      • Inpatient
      • 1 week
      • 6-8 weeks cardiac
      • Rehab programme
      • Outpatient
      • Hospital based
      • Supervised Exercise
      • Cardiac events
        • Angina (chest pain),
        • Coronary artery disease (blockages in the coronary arteries),
        • Heart attack (myocardial infarction),
        • Chronic heart failure, (CHF) (reduced pump function or cardiomyopathy),
        • Coronary arterial bypass graft (CABG), and stent or angioplasty procedures.
      Stage-1 Primary prevention Secondary prevention Stage-2 Sustain Healthy Lifestyle Reduces risk of Cardiac events
    • 13. Role of Exercises in Cardiac Rehabilitation
      • Improves autonomic nervous systems regulation of heart ( or heart rate imbalance)
        • Parasympathetic/ vagal tone (reduces heart rate) and sympathetic nervous system (increases heart rate).
        • Anxiety, fear, depression and other negative emotional states (even positive emotional states) can trigger excessive sympathetic nervous system which raises heart rate.
        • Exercise can improve cardiac autonomic balance (increasing parasympathetic while decreasing sympathetic regulation of heart)
          • Improves heart rate recovery *
          • Increases heart rate variabilty #
      * M. Kukielka, et al., Cardiac vagal modulation of heart rate during prolonged submaximal exercise in animals with healed myocardial infarction: effects of training, Am J Physiol. Heart Circ Physiol. 290,1680-1685 2005. # J. Myers et al., Effects of exercise training on heart rate recovery in patients with chronic heart failure, American Heart Journal, 153(6), 1056-1063, 2007.
    • 14. Cardiac Rehabilitation: Core elements
      • Cardiac Rehabilitation programs should offer a multifaceted approach to overall cardiovascular risk reduction – not only exercise training!
        • G.J. Balady et.al., “Core Components of Cardiac Rehabilitation/Secondary Prevention Programs: 2007 Update”, Circulation 2007;115:2675-2682
      • Core components of secondary prevention programs:
        • Nutritional counselling
        • Risk factor management: lipids, blood pressure, weight, diabetes, and smoking
        • Psychosocial interventions
        • Physical activity and exercise training
        • Baseline patient assessment
    • 15. CVD Management Programmes- Underused?
      • There is a significant underutilisation of Cardiac Rehabilitation programs. Only 16% of all the eligible patients complete a program in QLD. I.A.Scott et.al. “Utilisation of outpatient cardiac rehabilitation in Queensland”, MJA 2003; 179(7)
      • In the USA 18.7% of the eligible patients participate in rehabilitation programs.
      • Reasons:
        • Patient barriers:
          • self-care preferred
          • negative perception of gym-based group exercise
          • travel, work, cost, time issues and complex enrolment process
        • Provider barriers: lack of referrals (Around 30% of eligible patients are referred)
        • System barriers: competing demands, lack of support within the organization
        • Community barriers: lack of community support and positive media messaging R.J. Thomas, “Cardiac Rehabilitation/Secondary Prevention Programs; A Raft for the Rapids: Why Have We Missed The Boat?”, Circulation 2007;116:1644-1646
      • ->Alternative care models are required.
      Main Problem in Cardiac Rehabilitation:
    • 16.
      • Alternative care models
      • Patient centric care models
    • 17. Patient Centric Care Model CAP Server Wellness Diary Nutrition Info Excercise info Health Reports Wellness Diary Exercise coach Tele- Consultation Personal devices Health Records Health Information Self management Treatment Counselling Coaching
      • Movement activity - Heart Rate - Blood Pressure - Weight scale - Sleep-wake rhythm
      Mobile/PC Applications:
    • 18.
      • Clinical Trial
    • 19. Why Trials? New Technology Relevance Positive Outcomes Uptake Phase 1 trial Phase 2 trial
    • 20. Project phase 1 (2007) objectives
      • Conduct clinical trial for continuous physiological monitoring of patients undergoing cardiac rehabilitation using ambulatory monitoring devices to:
        • Identify various measures/tools used in hospitals to assess the patients conditions.
        • Develop and derive clinical measures/tools from free living environment.
        • Validate the clinical significance of free living based measures/tools
        • Use the validated free living measures to find new trends/patterns in patient’s behaviour and physiological signals.
      What automatically derived measures can be used to assess and follow the patient’s condition during the program?
    • 21.
        • Trial setup
    • 22. Phase 1 trial: Hospital-based cardiac rehabilitation program in Caboolture & Redcliffe hospitals (QLD)
      • 6 weeks cardiac rehabilitation program
        • Patient condition assessed at the beginning and end of the program using six minute walk test (6MWT)
        • Consent asked to participate in the research study
      • Patients attend physical exercise session twice a week at the hospital gym
        • Typical exercises: biking, rowing, walking, stepping, arm exercise and ball work out
        • Exercise duration and load varied by the physiotherapist to achieve optimal exercise level and increase the patient’s performance
      • Device worn continuously in the home for the duration of rehab
        • Device attached to waist with a belt and pouch, remove device only during shower
        • Data downloaded weekly from memory cards during rehab session
        • Patients wear ECG leads for the first half of the week and during exercise
      Monitor attached to waist
    • 23. Ambulatory Monitoring Technology in Phase 1: Waist worn movement activity monitor records X-, Y- and Z- acceleration and 1 lead ECG Sit to stand transition Walking Important movement patterns can be automatically detected:
    • 24. Cardiac rehabilitation exercise program
    • 25.
      • Clinically relevant measures for cardiac rehabilitation
    • 26.
        • Activities of Daily Living (ADL)
        • Sit to stand transition duration
        • Metabolic expenditure
        • Walking speed
        • Walking durations
        • Gait pattern – Fractal dimensions
        • Adverse events such as falls
      Clinically significant measures derived from measures of accelerometer signals…
        • Respiratory rate
        • Heart rate variability (HRV)
        • RMSSD
      derived from measures of ECG signals…
    • 27. Physical activity intensity
      • Moderate-intensity (3.0 to 6.0 METs): At least 30 minutes on 5 or more days of the week. e.g.,
        • walking at a moderate or brisk pace of 3 to 4.5 mph
        • Table tennis—competitive
        • Tennis—doubles
      • Vigorous-intensity (Greater than 6.0 METs) : 3 or more days per week for 20 or more minutes per occasion. e.g.,
        • Jogging or running ,wheeling on wheel chair
        • Boxing—in the ring, tennis (singles), swimming
        • Most competitive sports (football, soccer, rugby)
      Source: Centre for disease control and prevention http://www.cdc.gov/nccdphp/dnpa/physical/recommendations/index.htm
    • 28. Metabolic expenditure, daily profile Cardiac Rehabilitation aims at an accumulation of 30 minutes or more of light to moderate (3.2 – 4.7 MET) physical activity on most days of the week Minute by minute metabolic expenditure can be calculated from the accelerometer signal
    • 29. Metabolic expenditure trend during 6 week CR
    • 30. Active/Inactive Ratio trend during 6 weeks of CR Active (Running, Walking, working, etc) (Moderate and Vigorous intensity activities > 3MET) Inactive (Sleep, Lying down, Sitting) Days
    • 31. Sleep Distribution, daily profile
    • 32. Sleep Distribution,daily profile
    • 33. Gait stability trend during 6 weeks of CR
    • 34. Walking duration trend during 6 weeks of CR
    • 35. Ambulatory ECG Derived features
    • 36. Exercise heart rate distribution
    • 37. Continuous heart rate, daily profile
    • 38. Exercise respiratory rate distribution
    • 39. Continuous respiratory rate, daily profile
    • 40. Respiratory rate regularity (Smoothness)
    • 41. Heart rate variability (RMSSD) during exercise Resting – Parasympathetic/vagal tone active Exercise – Sympathetic > Parasympathetic
    • 42. Phase 1 clinical trial, summary
      • Derived from accelerometer signal:
        • Sit to Stand transition duration
        • Metabolic expenditure
        • Walking speed (6MWT)
        • Walking durations
        • Gait pattern
        • Sleep-wake patterns
        • Activities of Daily Living (ADL)
        • Adverse events such as falls
      • Derived from ECG signal:
        • Heart Rate distribution
        • Heart Rate Variability (HRV) and various derivatives (such as RMSSD)
        • Respiratory rate
      Set of clinically relevant measures to assess patient’s condition during cardiac rehabilitation Patient R1RC data Good Bad
    • 43. Human Factors Unacceptable Poor Average Good Excellent Comfortness of monitor on waist Comfortness ECG leads Trial satisfaction
    • 44. Human Factors No Sometimes Yes Disruption to Normal activities? Wear monitors During sleep? Did wearing monitor Encourage in setting exercise goals?
    • 45.
      • Future works
    • 46. CAP phase 2 (2008): objectives Establish a sustainable and comprehensive home-based care process assisted with IT solutions and show its benefits compared to conventional approaches through a randomized controlled clinical trial Create new clinical information on the behavioural and exercise patterns of the home-care patients through dynamic analysis of free living unconstrained physiological data To develop data analysis tools and a software framework to process clinically relevant information from the home-monitoring systems.
    • 47. Research questions - 2008
      • Does monitoring of patient’s behaviour, physical exercise and provision of lifestyle coaching and feedback lead to improved and sustainable quantifiable outcomes in patient’s health status and/or economical or other benefits to the care organisations thus enabling transition to home based care?
        • Readmission rate, Quality of life, cost-benefit analysis, medications
      • Does self-monitoring of physiological measures and automatic feedback improve patient’s self management thus decreasing the need for care personnel intervention?
        • Adherence – Acceptance, drop out
      • Is the home-based rehabilitation a better alternative to hospital based model?
        • Follow up evaluation
      • What methods can be used to motivate a cardiac patient to implement and sustain a life-style change?
        • Quality of Life, physiological and psychological evaluation
    • 48. Phase 2, Clinical study setup Patient Consent Test Group 2 Randomization Test Group 1 Control Group Pre- assessment of outcome measures Evaluation, analysis, reporting Hospital rehabilitation without IT, N=80 Test Group 3 Hospital rehabilitation using IT, N=80 Home-based care without IT N=80 Home-based care using IT N=80 Post- assessment of outcome measures Cost-effectiveness analysis Site1 Site2 No rehabilitation - self care, N=80 Test Group 4 6 months follow-up Drop out Evaluation, analysis, reporting
    • 49. Thank you Contact Us Phone: 1300 363 400 or +61 3 9545 2176 Email: enquiries@csiro.au Web: www.csiro.au e-Health Research Centre/ICT Centre Phone: +61 7 3024 1651 Email: niranjan.bidargaddi@csiro.au Web: http://e-hrc.net/cap/index.html

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