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

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

Dr Niranjan P BidargaddiResearch Scientist28th August 2008

Patient centred health care

CSIRO. 2nd International Conference on Pervasive Computing Technologies for Healthcare, Tampere, Finland. 2008

CSIROCommonwealth Scientific and Industrial Research Organization

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secondary prevention of Cardiovascular Diseases


Outline

1. Cardiovascular diseases – Facts

2. Care model: Hospital based cardiac rehabilitation Benefits and drawbacks

3. Alternative care models : Patient centric care models

4. Clinical Trial Objectives Trial setup

5. Clinically relevant measures for cardiac rehabilitation

6. Future works


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


Care model: Benefits and drawbacks


Prevention of Cardiovascular disease

Cardiac events

HealthyLifestyle

• Post-operation• Inpatient• 1 week

• 6-8 weeks cardiac Rehab programme• Outpatient • Hospital based• Supervised ExerciseCardiac 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 HealthyLifestyle

Reduces risk ofCardiac events


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.


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


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:


Alternative care models

Patient centric care models


Patient Centric Care Model

CAP ServerWellness

DiaryNutrition

InfoExcercise

infoHealth

Reports

Wellness Diary

Exercise coachTele-

Consultation

Personal devices

Server

DatabaseHealth Records

CAP.COM.AU

Organisation: Redcliffe Rehab

Thomas Anderson

Redcliffe Rehab

Summary

View Type Start date30 days before

End date

Today

Import Data Patient Info

Update

Good

Poor

Sit to Stand Time4

2

0

Tim

e [s

]

Current:

Average:

0.88 s

1.9 s

Start: 2.3 s

Good

Poor

6 Minute Walk6

3

0

Spee

d [km

/h] Current:

Average:

4.5 km/h

3.1 km/h

Start: 2.1 km/h

View

User: Mary Smith

Exit

System User Change Password

Anderson ThomasBrown MaryDavis JackDoe JohnJackson EmilyJohnson RyanJones MiaMiller PatrickMoore EmmaSmith JoeTaylor SamuelThomas SophieWilliams JoshWilson Jessica

Patients:

Add Remove

Cardiac Rehab #3

Patient Group:

Patients Settings

Select graphs

6min walk

Heart Rate

Good

Poor180

100

Fr 02.02.07Tu 23.01.07Sa 13.01.07

40Poor

HR [b

pm]

Current:

Average 30 days:

59 120 42

Start:

Average Max Min

85 143 50

103 135 62

HR 24 Hour Values

HealthInformatio

n

Self management

Treatment Counselli

ng Coaching

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

Mobile/PC Applications:


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?


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


Cardiac rehabilitation exercise program


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

derived from measures of accelerometer signals…

Clinically significant measures

Respiratory rate Heart rate variability (HRV) RMSSD

derived from measures of ECG signals…


Metabolic expenditure, daily profile

12:00 18:00 00:00 06:001

1.5

2

2.5

3

3.5

time

ME

T

Patient R1CR Metabolic expenditure 21.5.-22.5

Device not in use

Walking

Sleep

Rehab in Redcliffe 11am-12

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

5 10 15 20 251.05

1.1

1.15

Patient R5 mean 24h Energy Expenditure

day

MET


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

05/13 05/20 05/27 06/03 06/10 06/17 06/240

500

1000

1500

Dur

atio

n (m

inut

es)


Gait stability trend during 6 weeks of CR


Walking duration trend during 6 weeks of CR


Ambulatory ECG Derived features


Exercise heart rate distribution

20 40 60 80 100 120 140 1600

500

1000

1500

20 40 60 80 100 120 140 1600

5000

10000

15000

40 50 60 70 80 90 100 110 1200

500

1000

1500

40 60 80 100 120 140 1600

500

1000

1500

50 60 70 80 90 100 1100

500

1000

1500

40 60 80 100 120 140 160 1800

1000

2000

50 60 70 80 90 100 110 1200

1000

2000

3000

4000

40 60 80 100 120 140 1600

500

1000

1500

2000

Dur

atio

n (s

econ

ds)

Heart rate (beats per minute)

29th May 2007 (Rehabilitation)

14th May 2007 (Rehabilitation) 21th May 2007 (Day and Night)

4th June 2007 (Rehabilitation)

12th June 2007 (Rehabilitation)6th June 2007 (Rehabilitation)

20th June 2007 (Rehabilitation)18th June 2007 (Day time)


Respiratory rate regularity (Smoothness)


Heart rate variability (RMSSD) during exercise

10:00 10:15 10:30 10:45 11:000

20

40

60

12:00 15:00 18:00 21:00 00:00 03:000

50

100

11:00 11:10 11:20 11:30 11:40 11:50 12:00 12:100

20

40

60

11:00 11:10 11:20 11:30 11:40 11:50 12:00 12:10 12:200

20

40

60

11:15 11:30 11:45 12:00 12:150

20

40

11:00 11:10 11:20 11:30 11:40 11:50 12:00 12:10 12:200

20

40

11:00 12:00 13:00 14:00 15:00 16:000

20

40

60

80

10:00 10:30 11:00 11:30 12:00 12:300

20

40

60

5th May 2007 (Day and Night)14th May 2007 (Rehab Session)

29th May 2007 (Rehab Session) 4th June 2007 (Rehab Session)

6th June 2007 (Rehab Session) 12th June 2007 (Rehab Session)

18th June 2007 (Day) 20th June 2007 (Rehab Session)

Du

ratio

n (

mill

iSe

con

ds)

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


Human Factors

Unacceptable

Poor

Average

Good

Excellent

Comfortness of monitor on waist

Comfortness ECG leads

Trial satisfaction


Human Factors

No

Sometimes

Yes

Disruption toNormal activities?

Wear monitors During sleep?

Did wearing monitorEncourage in settingexercise goals?


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.


Phase 2, Clinical study setupPatient Consent

Test Group 2

Randomization

Test Group 1Control Group

Pre- assessment of outcome measures

Evaluation, analysis, reporting

Hospital rehabilitation

without IT, N=80

Test Group 3Hospital

rehabilitation using IT, N=80

Home-based care without IT

N=80

Home-based care using IT

N=80

Post- assessment of outcome measures Cos

t-effe

ctiv

enes

s an

alys

isSite1 Site2

No rehabilitation- self care, N=80

Test Group 4

6 months follow-up

Drop out

Evaluation, analysis, reporting


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