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Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients

NCT05196802 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2022-01-19

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

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)

Sponsors & Collaborators

  • Instituto Politécnico de Leiria

    collaborator OTHER

  • Escola Superior de Enfermagem de Coimbra

    lead OTHER

Principal Investigators

  • Pedro Sousa, PhD · Nursing School of Coimbra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-06-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196802 on ClinicalTrials.gov