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Clinical Trials/NCT05196802
NCT05196802
Not yet recruiting
Not Applicable

Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: Promoting Self-Management and Adherence to Treatment

Escola Superior de Enfermagem de Coimbra0 sites212 target enrollmentJanuary 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Decision Support Systems, Clinical
Sponsor
Escola Superior de Enfermagem de Coimbra
Enrollment
212
Primary Endpoint
Recurrent cardiovascular event rates
Status
Not yet recruiting
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2023
End Date
December 2026
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pedro Miguel Lopes de Sousa

Adjunct Professor

Escola Superior de Enfermagem de Coimbra

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.

Outcomes

Primary Outcomes

Recurrent cardiovascular event rates

Time Frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)

This outcome is a composite of cardiovascular rehospitalization or urgent visit, unplanned revascularization, cardiovascular mortality, or worsening heart failure

Secondary Outcomes

  • Quality of life score (assessed by the MacNew Heart Disease Health-related Quality of Life questionnaire)(Two measurement timepoints: 3-month (T1) and the 6-month (T2))
  • Adherence to treatment score (assessed by the Therapeutic Self-care Scale)(Two measurement timepoints: 3-month (T1) and the 6-month (T2))
  • Body Mass Index (in Kg/m^2)(Two measurement timepoints: 3-month (T1) and the 6-month (T2))
  • Health-Promoting Lifestyle score (assessed by the Health-Promoting Lifestyle Profile-II)(Two measurement timepoints: 3-month (T1) and the 6-month (T2))

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