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

CSIRO C ommonwealth S cientific and I ndustrial R esearch O rganization www.csiro.au

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28 PhD students

$48M pa

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

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

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

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

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

Cardiovascular diseases- Facts

Cardiovascular diseases- Facts

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

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.

Care model: Benefits and drawbacks

Care model: Benefits and drawbacks

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

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.

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.

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 #

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

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

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:

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.

Alternative care models Patient centric care models

Alternative care models

Patient centric care models

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:

Movement activity - Heart Rate - Blood Pressure - Weight scale - Sleep-wake rhythm

Clinical Trial

Clinical Trial

Why Trials? New Technology Relevance Positive Outcomes Uptake Phase 1 trial Phase 2 trial

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?

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.

Trial setup

Trial setup

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

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

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:

Cardiac rehabilitation exercise program

Clinically relevant measures for cardiac rehabilitation

Clinically relevant measures for cardiac rehabilitation

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…

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

Respiratory rate

Heart rate variability (HRV)

RMSSD

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

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)

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

Metabolic expenditure trend during 6 week CR

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

Sleep Distribution, daily profile

Sleep Distribution,daily profile

Gait stability trend during 6 weeks of CR

Walking duration trend during 6 weeks of CR

Ambulatory ECG Derived features

Exercise heart rate distribution

Continuous heart rate, daily profile

Exercise respiratory rate distribution

Continuous respiratory rate, daily profile

Respiratory rate regularity (Smoothness)

Heart rate variability (RMSSD) during exercise Resting – Parasympathetic/vagal tone active Exercise – Sympathetic > Parasympathetic

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

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

Human Factors Unacceptable Poor Average Good Excellent Comfortness of monitor on waist Comfortness ECG leads Trial satisfaction

Human Factors No Sometimes Yes Disruption to Normal activities? Wear monitors During sleep? Did wearing monitor Encourage in setting exercise goals?

Future works

Future works

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.

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

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

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

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