Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients (mHEART4U)

Escola Superior de Enfermagem de Coimbra

Status: Not yet enrolling

Conditions: Decision Support Systems, Clinical

Treatments: Combination Product: mHeart.4u

Study type: Interventional

Funder types: Other

Identifiers

NCT05196802

mHEART.4U

Details and patient eligibility

About

Cardiovascular diseases (CVD) are the leading cause of death worldwide, taking an estimated 17.9 million lives each year. The reduction of CVD-related mortality and morbidity is a key global health priority. Cardiac rehabilitation (CR) is a multi-factorial and comprehensive intervention in secondary prevention, being recommended in international guidelines. Core components in CR include patient assessment, physical activity counseling, nutritional counseling, risk factor control, patient education, and psychosocial management. CR has been shown to reduce mortality, hospital readmissions, costs, as well as to improve physical fitness, quality of life, and psychological well-being. However, despite the recommendations and proven benefits, acceptance and adherence remain low. Access to health technologies in all primary and secondary healthcare facilities can be essential to ensure that those in need receive treatment and counseling.

Using mobile health (mHealth) solutions may contribute to more personalized and tailored patient recommendations according to their specific needs. Also, these technologies contribute to increasing the flexibility, quality, and efficiency of the services provided by health institutions.

Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real-time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support systems (CDSS) provides an effective solution to these problems. There are several computerized CDSS for managing chronic diseases; however, to the best of our knowledge, there are none for the e-management of patients with CVD.

The purpose of this transdisciplinary research project is to develop and evaluate a user-friendly, comprehensive CDSS for remote monitoring of CVD patients. The CDSS will suggest a monitoring plan for the patient, advise the mHealth tools (apps and wearables) adapted to patient needs, and collect data. The primary outcome will be the reduction of recurrent cardiovascular events (a composite of cardiovascular rehospitalization or urgent consultation, unplanned revascularization, cardiovascular mortality, or worsening heart failure).

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients attending the cardiology outpatient clinics after the onset of acute cardiac event OR
• Patients attending the cardiology outpatient clinics who are engaged in a structured Cardiac Rehabilitation program
• Be able to communicate with the researcher

Exclusion criteria

• Participants will be excluded if they have New York Heart Association class III/IV heart failure, terminal disease, or significant non-cardio vascular disease exercise limitations.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

mHeart.4u

Experimental group

Description:

The mHEART.4U intervention includes the use of an online Clinical Decision Support System (CDSS) for remote patient monitoring. According to the patient needs and profile, the CDSS will suggest a monitoring plan for the patient. The mHEART.4U kit will include mobile apps and wearables, such as heart rate, blood pressure, peripheral oxygen saturation (SpO2), sleep and step trackers, symptoms, lifestyle self-monitoring tools, medication reminders or motivational resources. The intervention length will be 6 months and will take into account the most recent guidelines on Cardiac Rehabilitation.

Treatment:

Combination Product: mHeart.4u

Standard care

No Intervention group

Description:

This arm will receive treatment and care according to the prevailing practice at each of the cardiac hospital units.