Integrative Telerehabilitation Strategy after Acute Coronary Syndrome
1
Integrative Telerehabilitation Strategy after Acute Coronary Syndrome Ernesto Dalli a , Sergio Guillén b , Ignacio Basagoiti b , Jaime H. Horta a , Lourdes Peñalver a , José L. Marqués c , Clara Bonanad d a Department of Cardiology, Hospital Arnau de Vilanova, b TSB SA , c Departament of Cardiology, Hospital Politécnico Universitario La Fe, d Department of Cardiology, Hospital Clínico Universitario, Valencia, Spain. INTRODUCTION Cardiac Rehabilitation and Secondary Prevention (CRSP) is one evidence based, cost-effective, multidisciplinary method for individual patient risk factor assessment and management, for exercise training and for psychosocial support for patients with heart disease that reduces mortality by 12% to 34% [1,2]. It’s recognized as Class I indication in the latest guidelines by the major scientific societies. Most CR programs are short-term interventions. The benefit of cardiac CRSP is directly related to the time that the patient remains in the program. Some recent studies (e.g. EuroAction [3] and GOSPEL [4]) have specifically aimed at maintaining beneficial long term life changes and improving prognosis in cardiac patients. Barriers to participation include low referral rates, patient difficulty attending center-based rehabilitation sessions, and cost [5]. Advances in technology and the rising costs of health care suggest that mHealth is going to be the most cost-effective method of delivering high-quality care for most patients, shifting from episodically care to continuous care with more frequent follow-up on the patients’ health status, and involving patients in their own care and the adoption of a healthier lifestyle. Empowering patients to play a more active role in their own disease management is crucial but remains a major challenge. In order to enhance clinical and economic benefits of home telemonitoring it is necessary to shift the emphasis of delivering care from doctors and nurses to the patients themselves adopting new strategies supporting self-management. PURPOSE This study aims at validating a new Integrated Telerehabilitation Model supporting post ACS rehabilitation and secondary prevention , and its usefulness in terms of improving adherence to exercise and cardiovascular risk self management. METHODS RESULTS Phase 3 clinical trial, pragmatic , open, randomized controlled trial, with two arms (telerehabilitation group and conventional CR group in the hospital). A quasi-experimental study will be performed, including a nonequivalent control group without rehabilitation, coming from an hospital without CR. Objectives of the stydy The primary outcome is the objective evaluation of the adherence to exercise activity using the IPAQ questionnaire and shuttle test distance. Secondary outcomes are control of cardiovascular risk factors, change in lifestyle and cost analysis. Study groups After an uncomplicated acute coronary syndrome and a maximal treadmill test, all eligible patients will be randomized to either: A) a control branch (n=30) of a conventional 8-weeks in-hospital rehabilitation program or, B) an intervention group (n=30) trained on the use of the App during two weeks in the hospital and following the CRSP program during 10 months outside hospital, i.e. at home. Full integrated tele-rehabilitation model will be delivered to group B. Educational talks will be the same for both groups. Two face-to-face interviews are scheduled at month 4 and 10. CONCLUSION The proposed CRSP model has the potential of being a useful, cost-effective tool, shifting part of the responsibility of improving health-related behaviours to patients, while facilitating access to services anywhere – anytime and longer time adherence to treatment. BIBLIOGRAPHY [1] Balady GJ, et al. Core components of cardiac rehabilitation/secondary prevention programs, 2007 Circulation. 2007;115:2675– 2682. [2] Piepoli MF, et al. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010;17:1–17. [3] Wood DA, et al., on behalf of EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet 2008;371:1999–2012. [4] Giannuzzi P, et al. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med 2008;168: 2194–2204. [5] Jackson L, Leclerc J, Erskine Y, Linden W. Getting the most out of cardiac rehabilitation: a review of referral and adherence predictors. Heart. 2005;91:10–14 CLINICAL MNG TELEMONITORING Professional software platform Patient’s WEB Patient’s APP Patient software platform Health status and CVRF automatically assessed by multiparametric indicators Dynamic stratification according to risk and need of non-programmed intervention Decision support for professional Process workflow and intervention follow-up Both, automatic and manual generation of messages Two way communication with patient. Patient admission to the Rehabilitation Program Standard Care Plans and Customized Care Plans Prescription of Patient’s personalized Care Plan Patient’s Risk Profile building and patient’s individual objectives setting Long term follow-up of Risk Factors progress and events occurred. Advisory and counselling on long term self management of risk factors. Diary: agenda of daily activities according with care plan Medication reminder and intake monitoring Measurement of vital signs and analytic values o Heart rate o Blood pressure o Glucose o TCol, LDLC, HDLC, TGLY o Body Weight Programmed exercise o Three stages o Guidance and feedback (voice and images) o Measurements: HR (bpm), Calories (Kcal), METs, distance (m), speed (Km/h), rhythm (Min/Km), Time (hh:mm) o Quality index of exercise (%) Questionnaires o Anxiety – Depression (HAD) o Adherence to Mediterranean diet (PREDIMED) o Quality of life (SF-12) o Physical exercise (IPAQ) My heath status o My care plan o My risk factors o My objectives and achievements Messages in box Access to certified information: www.salupedia.com Heart rate monitor. Compression comfortable t-shirt / bra of different sizes and gender design. Low energy Bluetooth connectivity with Patient’s APP Direct measurement: Heart Rate, alert disconnection Real time Sync with Telemonitoring station Detailed exercise plan over the full period of care program: o Calendar o Objectives for each phase. o Achievements and results statistics o Historical data and aggregated data Risk factors evolution over time and program. Global achievements Access to certified information: Salupedia, YouTube and blogs Programs of literacy on health and CV health Other to be added Patients in the intervention group B will be provided with a full patient’s package consisting of an Android smartphone (Motorola MOTO G), one heart rate monitor equipment and a user manual. As well, patients will be supported by the Telemonitoring Center on heath and rehabilitation program issues, and by the Logistics and Technical Support on any technical problems. The protocol was approved by the ethics committee. The study is pending of approval by the Spanish agency of drug and medical technology Preliminary Assessment High level of user acceptance was obtained in a pre-clinical test with 10 patients in three focus group sessions where individuals where introduced to the concept and tried the system for an hour. 0,00% 20,00% 40,00% 60,00% 80,00% 100,00% 1 Fit in daily life Easy Stimulating Enjoiable Scaring Interesting User experience Very negative Negative Neutral Positive very positive PATIENT’S SMARTPHONE APPLICATION TECHNOLOGY SYSTEM SUPPORTING CRSP MODEL PATIENT’S EQUIPMENT PATIENT’S WEB TELEMONITORING STATION CLINICAL MANAGEMENT STATION 75 95 Objective: Heart Rate Time Today Walk Pause
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Poster presentation in e-Cardiology & e-Health Congress Berna 2014 by Ernesto Dalli , Sergio Guillén , Ignacio Basagoiti , Jaime H. Horta , Lourdes Peñalver , José L. Marqués , Clara Bonanad from Department of Cardiology, Hospital Arnau de Vilanova, TSB SA , Departament of Cardiology, Hospital Politécnico Universitario La Fe and Department of Cardiology, Hospital Clínico Universitario, Valencia, Spain.
Transcript of Integrative Telerehabilitation Strategy after Acute Coronary Syndrome
Integrative Telerehabilitation Strategy after Acute Coronary Syndrome
Ernesto Dalli a , Sergio Guillén b, Ignacio Basagoiti b, Jaime H. Horta a, Lourdes Peñalver a, José L. Marqués c, Clara Bonanad d
a Department of Cardiology, Hospital Arnau de Vilanova, b TSB SA , c Departament of Cardiology, Hospital Politécnico Universitario La Fe, d Department of Cardiology, Hospital Clínico Universitario, Valencia, Spain.
INTRODUCTION
Cardiac Rehabilitation and Secondary Prevention (CRSP) is one evidence based, cost-effective, multidisciplinary method for individual patient risk factor assessment and management, forexercise training and for psychosocial support for patients with heart disease that reduces mortality by 12% to 34% [1,2]. It’s recognized as Class I indication in the latest guidelines by themajor scientific societies.
Most CR programs are short-term interventions. The benefit of cardiac CRSP is directly related to the time that the patient remains in the program. Some recent studies (e.g. EuroAction [3]and GOSPEL [4]) have specifically aimed at maintaining beneficial long term life changes and improving prognosis in cardiac patients. Barriers to participation include low referral rates,patient difficulty attending center-based rehabilitation sessions, and cost [5].
Advances in technology and the rising costs of health care suggest that mHealth is going to be the most cost-effective method of delivering high-quality care for most patients, shifting fromepisodically care to continuous care with more frequent follow-up on the patients’ health status, and involving patients in their own care and the adoption of a healthier lifestyle.
Empowering patients to play a more active role in their own disease management is crucial but remains a major challenge. In order to enhance clinical and economic benefits of hometelemonitoring it is necessary to shift the emphasis of delivering care from doctors and nurses to the patients themselves adopting new strategies supporting self-management.
PURPOSE
This study aims at validating a new Integrated Telerehabilitation Model supporting post ACS rehabilitation and secondary prevention , and its usefulness in terms of improving adherence toexercise and cardiovascular risk self management.
METHODS
RESULTS
Phase 3 clinical trial, pragmatic , open, randomized controlled trial, with two arms (telerehabilitation group and conventional CR group in the hospital).
A quasi-experimental study will be performed, including a nonequivalent control group without rehabilitation, coming from an hospital without CR.
Objectives of the stydy
The primary outcome is the objective evaluation of the adherence to exercise activity using the IPAQ questionnaire and shuttle test distance. Secondary outcomesare control of cardiovascular risk factors, change in lifestyle and cost analysis.
Study groups
After an uncomplicated acute coronary syndrome and a maximal treadmill test, all eligible patients will be randomized to either: A) a control branch (n=30) of aconventional 8-weeks in-hospital rehabilitation program or, B) an intervention group (n=30) trained on the use of the App during two weeks in the hospital andfollowing the CRSP program during 10 months outside hospital, i.e. at home. Full integrated tele-rehabilitation model will be delivered to group B. Educational talkswill be the same for both groups. Two face-to-face interviews are scheduled at month 4 and 10.
CONCLUSIONThe proposed CRSP model has the potential of being a useful, cost-effective tool, shifting part of the responsibility of improving health-related behaviours to patients, while facilitating access to services anywhere – anytime and longer time adherence to treatment.
BIBLIOGRAPHY[1] Balady GJ, et al. Core components of cardiac rehabilitation/secondary prevention programs, 2007 Circulation. 2007;115:2675–
2682.[2] Piepoli MF, et al. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from
the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J CardiovascPrev Rehabil. 2010;17:1–17.
[3] Wood DA, et al., on behalf of EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovasculardisease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high riskof cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet 2008;371:1999–2012.
[4] Giannuzzi P, et al. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of theGOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med2008;168: 2194–2204.
[5] Jackson L, Leclerc J, Erskine Y, Linden W. Getting the most out of cardiac rehabilitation: a review of referral and adherencepredictors. Heart. 2005;91:10–14
CLINICAL MNG TELEMONITORING
Professional software platform
Patient’s WEBPatient’s APP
Patientsoftware platform
Health status and CVRF automatically assessed by multiparametric indicators
Dynamic stratification according to risk and need of non-programmed intervention
Decision support for professional
Process workflow and intervention follow-up
Both, automatic and manual generation of messages
Two way communication with patient.
Patient admission to the Rehabilitation Program
Standard Care Plans and Customized Care Plans
Prescription of Patient’s personalized Care Plan
Patient’s Risk Profile building and patient’s individual objectives setting
Long term follow-up of Risk Factors progress and events occurred.
Advisory and counselling on long term self management of risk factors.
Diary: agenda of daily activities according with care plan
Medication reminder and intake monitoring
Measurement of vital signs and analytic valueso Heart rateo Blood pressureo Glucoseo TCol, LDLC, HDLC, TGLYo Body Weight
Programmed exerciseo Three stageso Guidance and feedback (voice and images)o Measurements: HR (bpm), Calories (Kcal), METs, distance
(m), speed (Km/h), rhythm (Min/Km), Time (hh:mm)o Quality index of exercise (%)
Questionnaireso Anxiety – Depression (HAD)o Adherence to Mediterranean diet (PREDIMED)o Quality of life (SF-12)o Physical exercise (IPAQ)
My heath statuso My care plano My risk factorso My objectives and achievements
Messages in box
Access to certified information: www.salupedia.com
Heart rate monitor. Compression comfortable t-shirt / bra of different sizes and gender design.
Low energy Bluetooth connectivity with Patient’s APP
Direct measurement: Heart Rate, alert disconnection
Real time Sync with Telemonitoring station
Detailed exercise plan over the full period of care program:o Calendaro Objectives for each phase.o Achievements and results
statisticso Historical data and aggregated
data
Risk factors evolution over time and program.
Global achievements
Access to certified information: Salupedia, YouTube and blogs
Programs of literacy on health and CV health
Other to be added
Patients in the intervention group B will be provided with a full patient’s package consisting of an Androidsmartphone (Motorola MOTO G), one heart rate monitor equipment and a user manual. As well, patients will besupported by the Telemonitoring Center on heath and rehabilitation program issues, and by the Logistics andTechnical Support on any technical problems.
The protocol was approved by the ethics committee. The study is pending of approval by the Spanish agency ofdrug and medical technology
Preliminary AssessmentHigh level of user acceptance was obtained in a pre-clinical test with 10 patients in three focus group sessionswhere individuals where introduced to the concept and tried the system for an hour.
0,00% 20,00% 40,00% 60,00% 80,00% 100,00% 120,00%
Fit in daily life
Easy
Stimulating
Enjoiable
Scaring
Interesting
User experience
Very negative Negative Neutral Positive very positive
PATIENT’S SMARTPHONE APPLICATION
TECHNOLOGY SYSTEM SUPPORTING CRSP MODEL
PATIENT’S EQUIPMENT
PATIENT’S WEB
TELEMONITORING STATIONCLINICAL MANAGEMENT STATION
75
95Objective:
Heart Rate
Time
Today
Walk
Pause
