CONTRIBUTION OF TELEMEDICINE & INFORMATION …€¦ · Parati G, et al. J Hypertens. 2009:27:198–203. 0 2 4 6 8 10 12 14 16 Control GroupTELEHBPM (n=111) (n=187) (%) heir (%) TeleBPCare

CONTRIBUTION OF TELEMEDICINE & INFORMATION TECHNOLOGY TO HYPERTENSION CONTROLProf. Gianfranco Parati

Dept of Medicine and Surgery, University of Milano-Bicocca Dept of Cardiovascular, Neural and Metabolic Sciences, St. Luca Hospital, Istituto Auxologico ItalianoMilan, Italy

DISCLAIMER SLIDE

• Honoraria for lectures by Omron HealthCare, Pfizer, Bayer, Sanofi, Servier

• The opinions expressed in this presentation are those of the presenter and not necessarily endorsed by Pfizer.

• For all pharmaceutical products mentioned, please consult the relevant approved Summaries of Products’ Characteristics (SPCs)

CONTENTS

• Home BP monitoring

• Telemedicine

• Mobile medical apps

• ESH Care app

3

MAIN CAUSES OF DEATH WORLDWIDE

Ezzati M, Riboli E. N Engl J Med. 2013;369:954-964.

CAUSES OF POOR HT CONTROL

1. Physicians’ inertia

2. Patients’ low adherence to treatment

3. Deficiencies in chronic disease management by healthcare systems

HT, hypertensionWilliams B, et al. Eur Heart J. 2018;39:3021-3104.

IMPORTANCE OF HOME BP MONITORING

BP, blood pressure

ROLE OF SELF BP MONITORING AT HOME

TOOL FOR BETTER PATIENT

COOPERATION AND MORE EFFECTIVE

BP CONTROL

STANDARDIZED RELATIVE RISK OF BP BELOW TARGET IN PEOPLE MONITORING BP AT HOME

COMPARED WITH PEOPLE WHOSE BP WAS MONITORED BY HEALTH PROFESSIONALS IN

CLINICAL SETTINGS

Cappuccio FP, et al. BMJ. 2004;329:145.

EFFECTS OF HOME BP MONITORING

BP, blood pressure; HBPM, home-based blood pressure monitoringMarquez-Contreras E, et al. J Hypertens. 2006;24:169–175.

9294

8988

93

74

88

84

80

87

70

75

80

85

90

95

100

Compliance Doses taken Correct days Correct time Therapeutic cover

Pe

rce

nta

ge (

%)

HBPM (n=100)No HBPM (n=100)

***P=0.0001; **P<0.001; *P<0.01aCompliance = 80–100%; b% of days on which antihypertensive drug was taken correctly; c% of patients taking the medication at the prescribed time

a

*****

****

***

b c

A prospective controlled multicentre clinical trial in 250 patients with newly diagnosed or uncontrolled hypertension

Problems with SBPM reporting

HOME (SELF) MONITORING

SBPM, self-blood pressure monitoring

Omron HEM-5001

Graphic display of weekly-monthly-average BP

HBPM DEVICE WITH MEMORY AND GRAPHIC DISPLAY

BP, blood pressure; HBPM, home blood pressure monitoring

PROBLEMS WITH MEMORY EQUIPPED HOME BP MONITORING DEVICES

• Data stored over different time periods in different devices

• Blood pressure measurements taken from different family members could be stored in the same memory log

• Risk of having average family BP levels rather than individual BP values!

BP, blood pressure

TELEMEDICINE

BP, blood pressure

• Increased compliance • Health education• Improved patient-doctor

relationship• Reduced number of

unnecessary clinic accesses

• Increased health• Reduced costs

1) Self BP measurement

2) Teletransmission

3) Feedback

4) Education

Bi-LINKOnline Health Management Platform

MicrolifeWatch BP PC interface Data Management

A&DCentral Location Store

Track Manage

Home BP Telemonitoring

BP, blood pressure

PATIENT GENERAL PRACTITIONER

A&d UA-767PC DEVICE & GSM/GPRS INTERFACE

WWW.MOREPRESS.NET

THE MOREPRESS® WEB-BASED HBPM SYSTEM

HBPM, home blood pressure monitoring

N=113►Usual Care Office BP

N=216►Telemedicine Home BP

ABPM: baseline and after 6 ms.

Randomized

TeleBpcare study

ABPM, ambulatory blood pressure monitoring; BP, blood pressureParati G, et al. J Hypertens 2009;27:198-203.

HBPM MONITORING MAY FAVOR BP CONTROL AND PT COMPLIANCE VS OFFICE BP MONITORING,

PARTICULARLY WHEN COMBINED WITH TELETRANSMISSION

BP, blood pressure; DBP, diastolic blood pressure; HBPM, home blood pressure monitoring; SBP, systolic blood pressureParati G, et al. J Hypertens. 2009:27:198–203.

0

2

4

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14

16

Control Group TELEHBPM(n=111) (n=187)

Pati

ents

wh

o a

lter

ed t

hei

r tr

eatm

ent

(%)

Sub

ject

s w

ith

day

tim

e B

P n

orm

alis

atio

n*

(%)

TeleBPCare study 35.6% reduction P=0.04

(n=111) (n=187)

0

10

20

30

40

50

60

70

Control Group TELEHBPM

P<0.05

*SBP <130 mmHg and DBP <80 mmHg

Remote monitoring of home BP with dedicated devices improves BP control

HOME BP TELEMONITORING

BP, blood pressureOmboni S, et al. J Hypertens. 2013;31:455-467.

SELF-MONITORING: META-ANALYSIS

Tucker KL, et al. PLoS Med. 2017;14:e1002389.

SELF-MONITORING: META-ANALYSIS

Tucker KL, et al. PLoS Med. 2017;14:e1002389.

HOME BP TELEMONITORING

• Effective, but… what about the real world?

• Use of BP telemonitoring out of a clinical trial setting in daily practice is difficult to implement

• High installation and maintenance costs

• No reimbursement

BP, blood pressure

MOBILE HEALTH

• Smartphones as a new opportunity

• Increasing diffusion of smartphones: 3.4 billion users in 2016

• 50-60% of smartphone users have downloaded at least one mobile health app

• Incredibly rapid diffusion of wearable sensors and of smartphone applications (but mostly for “fitness” or “wellness” purposes – limited clinical and scientific validation)

• Increasing awareness of the possible benefits of remote patient management through telemedicine

https://www.emarketer.com/Report/Worldwide-Internet-Mobile-Users-eMarketers-Estimates-2016/2001798. Accessed November 2018.

MOBILE DEVICES & APPLICATIONS

• Mobile devices and health-related apps have the potential to support the patient in the process of empowerment, to facilitate the chronic patient to assume a more active role in the management of his/her pathology, as well as the citizen for health prevention through an appropriate lifestyle

Apps for personalized

e-Health

Apps for engaging research

participants

Apps to support care

delivery

Apps for medical

education

BUT… WE HAVE A PROBLEM:

https://liquid-state.com/mhealth-apps-market-snapshot/. Accessed November 2018.

App pollution!

Today, >318,000 health apps are available online (+200/day)

Professional liability

• Validity and accuracy, demonstration of efficacy

• Privacy and security

• Data quality when acquisition performed by the patient

• Data integrity

• Physician dedication to interpret collected data

• Lack of specific reimbursements

TO PRESCRIBE OR NOT TO PRESCRIBE A DIGITAL HEALTH SOLUTION...

Observational Study

Randomized Controlled Trial

Systematic Reviews

Meta-analysis

EFFICACY OF DIGITAL HEALTH SOLUTIONS

IQVIA AppScript Clinical Evidence Database, August 14, 2017. Available from: https://digitalhealth.london/wp-content/uploads/2018/04/DigitalTherapeuticsNHS.pdf. Last accessed, November 6th, 2018.

571 studies between 2007-2017

Blood pressure monitor with bluetooth/WIFI

ACQUISITION OF SINGLE OR MULTIPLE SIGNALS

WHAT IS THE CONTRIBUTION FROM INFORMATION TECHNOLOGY?

• Limited number of apps “validated” in their content and functions to be used in a HEALTHCARE environment

• Limited use of smartphone apps to improve HEALTHCARE in cooperation with Scientific Societies and with medical environment/health care system

Need for dedicated, updated European guidelines

OPEN ISSUES

https://www.fda.gov/medicaldevices/digitalhealth/mobilemedicalapplications/default.htm. Accessed November 2018.

MOBILE HEALTH

Parati G, et al. Curr Hypertens Rep. 2017;19:48.

ESH CARE APP

• Stores, shows in graphs and transmits BP values, body weight and height

• Provides educational material

• Connects patients with their physician

• Locates ESH Excellence Centers all over Europe

ESH, European Society of Hypertensionhttp://www.eshonline.org/. Accessed November 2018.

ESH CARE APP


ESH CARE APP


New section on Children, Blood Pressure and Hypertension Prevention coming soon

ESH CARE APP


ESH CARE APP


ESH CARE APP


ESH CARE APP


ESH CARE APP


ESH CARE APP


Research

ESH CARE


<<Street Epidemiology>>Questionnaire implemented with request

for informed consent

THE ESH CARE APP

• Is the ESH CARE app really effective in improving hypertension management?

• How to combine it with hypertension management systems?

PATIENT (checks HomeBP)

FIELD DOCTOR (Specialist or GP)

By Personal Computer

Or by Smartphone

Instructions for HBPM Prescriptions and advice

Clinical Data from office Visits

HBPM data upload: Statistics and Graphs

HBPM online

transmission Smartphones ESH-App

BP, blood pressure; CV, cardiovascular; HBPM, home blood pressure monitoringhttp://www.eshonline.org/. Accessed November 2018.

CDMS-misuriamo

Storage System for HBPM

BP statistics and graphs morning/evening

online eCRF (www.misuriamo.eu)

For integrated global management of CV risk and of pharmacological

therapies

THE ESH CARE APP

• New management strategy of hypertensive patients, consisting of conventional office visits combined with • Mobile application “ESH CARE”

• Online platform («Misuriamo» platform) for optimal and simplified data management by clinicians

ESH, European Society of Hypertension

Patient Optimal Strategy for Treatment (POST)

POST-STRATEGY: PILOT STUDY

Albini F, et al. Abstract presented at the 38th Annual International Conference of the IEEE Engineering in Medicine. Available from: https://ieeexplore.ieee.org/document/7590753. Last accessed, November 6th, 2018.

RESULTS

Albini F, et al. Abstract presented at the 38th Annual International Conference of the IEEE Engineering in Medicine. Available from: https://ieeexplore.ieee.org/document/7590753. Last accessed, November 6th, 2018.

Mean office BP <140/90 = 39.9%

Mean office BP <140/90 = 72.3%

Mean home BP <135/85 = 87.5%

0

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BP target achieved in control group: 298 patients managed in usual care (3 scheduled visits in 6 months)

BP target achieved (office BP)in Misuriamo group: 303 patient managed by telemedicine support (3 scheduled visits in 6months)

BP target achieved (tele homeBP)in Misuriamo group: 303 patient managed by telemedicine support (3 scheduled visits in 6months)

POST GroupPOST GroupCONTROL Group

Pat

ien

ts (

%)

CONCLUSIONS

• Combination of new technologies as: • HBP telemonitoring, e-Health and m-Health solutions

may represent a valuable approach

• to improve patients’ management and patients’ compliance,

• to fight physicians’ inertia and

• to optimize cost-effectiveness ratio in HT management

HT, hypertension

ESH CARE

CONCLUSIONS

ESH, European Society of Hypertension

Need of randomized controlled longitudinal studies to test the

actual effectiveness of ICT-based interventions

Documents

CONTRIBUTION OF TELEMEDICINE & INFORMATION …€¦ · Parati G, et al. J Hypertens. 2009:27:198–203. 0 2 4 6 8 10 12 14 16 Control GroupTELEHBPM (n=111) (n=187) (%) heir (%) TeleBPCare