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临床试验/NCT05196802
NCT05196802尚未招募不适用

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

Escola Superior de Enfermagem de Coimbra0 个研究点目标入组 212 人开始时间: 2023年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
212
主要终点
Recurrent cardiovascular event rates

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Recurrent cardiovascular event rates

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Miguel Lopes de Sousa

Adjunct Professor

Escola Superior de Enfermagem de Coimbra

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