1) The study aims to validate an integrated telerehabilitation model to support post-acute coronary syndrome rehabilitation and secondary prevention using mobile technologies and telemonitoring. 2) Patients will be randomized into two groups - a control group receiving conventional in-hospital rehabilitation and an intervention group using a mobile app and telemonitoring for 10 months of at-home rehabilitation. 3) The primary outcome is adherence to exercise measured by questionnaires and exercise tests, with secondary outcomes of cardiovascular risk factor control, lifestyle changes, and cost analysis.

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 APP Patient’s WEB
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% 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
CLINICAL MANAGEMENT STATION TELEMONITORING STATION
75
Objective:95
Heart Rate
Time
Today
Walk
Pause