Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients

NCT ID: NCT05196802

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2026-12-31

Brief Summary

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).

Conditions

Decision Support Systems, Clinical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mHeart.4u

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.

Group Type: EXPERIMENTAL

mHeart.4u

Intervention Type: COMBINATION_PRODUCT

The mHeart.4U is a multiple-components intervention entailing the adoption and use of technological devices and self-management recommendations tailored to behavioural modifications (e.g. physical exercise and dietary patterns)

Standard care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mHeart.4u

The mHeart.4U is a multiple-components intervention entailing the adoption and use of technological devices and self-management recommendations tailored to behavioural modifications (e.g. physical exercise and dietary patterns)

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Politécnico de Leiria

OTHER

Sponsor Role: collaborator

Escola Superior de Enfermagem de Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Pedro Miguel Lopes de Sousa

Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro Sousa, PhD

Role: PRINCIPAL_INVESTIGATOR

Nursing School of Coimbra

Central Contacts

Pedro Sousa, PhD

Role: CONTACT

pmlsousa@esenfc.pt

+351 239 802 850

References

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

mHEART.4U

Identifier Type: -

Identifier Source: org_study_id