Home-Based Intervention Tool for Cardiac Telerehabilitation: Protocol for a Controlled Trial
Authors: Mastorci Francesca , Lazzeri Maria Francesca Lodovica , Ait-Ali Lamia , Marcheschi Paolo , Quadrelli Paola , Mariani Massimiliano , Margaryan Rafik , Pennè Wanda , Savino Marco , Prencipe Giuseppe , Sirbu Alina , Ferragina Paolo , Priami Corrado , Tommasi Alessandro , Zavattari Cesare , Festa Pierluigi , Dalmiani Stefano , Pingitore Alessandro 
Published: January 2025

Background
Among cardiovascular diseases, adult patients with congenital heart disease represent a population that has been continuously increasing, which is mainly due to improvement of the pathophysiological framing, including the development of surgical and reanimation techniques. However, approximately 20% of these patients will require surgery in adulthood and 40% of these cases will necessitate reintervention for residual defects or sequelae of childhood surgery. In this field, cardiac rehabilitation (CR) in the postsurgical phase has an important impact on the patient by improving psychophysical and clinical recovery in reducing fatigue and dyspnea to ultimately increase survival. In this context, compliance with the rehabilitation program is a key element for the therapeutic benefits of the program. The increase of mobile health care devices and software has greatly extended self-care capabilities across the spectrum of health care activities. Moreover, the possibility of telemonitoring the progress of this self-care provides elements of empowerment and awareness of one’s state of health. As a branch of telehealth, CR can be optimized and facilitated using remote telemedicine devices.

Objective
The principal goal of the Innovation in Postoperative Rehabilitation Training and Monitoring (IPOTERI) study is to design, realize, and test a composite and integrated system for postsurgical rehabilitation therapies at home specialized for cardiac surgery. The secondary aims are to implement the system in a “real-life” context of postcardiac surgical rehabilitation, and to create a data set and a data collection methodology to prototype data analytics algorithms and artificial intelligence techniques for customizing the rehabilitation pathway.

Methods
The IPOTERI method consists of a telemonitoring platform that guarantees continuity of postoperative care, an intelligent home station based on an Android app for the patient with a user-friendly interface to record vital signals (electrocardiogram, blood pressure, oxygen saturation, and body weight) and access the planning of rehabilitation activities, and a decision support system that communicates with hospital medical records to transmit alerts and specific support information for the formulation and updating of the treatment and care plan.

Results
The pilot test started in June 2023 (protocol number 20406/2021) including 50 patients who will be monitored for 12-14 weeks using the developed platform, as described in the Procedures subsection of the Methods section.

Conclusions
The IPOTERI approach, based on the processing of data recorded during the monitoring of telemedicine devices used at home during the postsurgical rehabilitation of a cardiac patient, together with clinical data from the perioperative and postoperative periods could have positive effects on adherence to the rehabilitation program and clinical improvement as well as result in overall improvement of quality of life.

International Registered Report Identifier (IRRID)
DERR1-10.2196/47951