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

January 6, 2022 updated by: Pedro Miguel Lopes de Sousa, Escola Superior de Enfermagem de Coimbra

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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)
NO_INTERVENTION: Standard care
This arm will receive treatment and care according to the prevailing practice at each of the cardiac hospital units.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score (assessed by the MacNew Heart Disease Health-related Quality of Life questionnaire)
Time Frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
The MacNew Heart Disease Health-related Quality of Life questionnaire consists of 27 items which fall into three domains (physical limitations domain scale, emotional function domain scale, and social function domain scale). Scoring of the MacNew is straight-forward. The maximum possible score in any domain is 7 (high quality of life) and the minimum is 1 (poor quality of life).
Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Adherence to treatment score (assessed by the Therapeutic Self-care Scale)
Time Frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
The Therapeutic Self-care Scale total score (from 0 to 60 points) corresponds to a high level of performance in therapeutic self-care. The scale is designed to assess patients' ability to engage in four aspects of self-care: taking medications as prescribed by the doctor; identifying and managing symptoms; performing activities of daily living; and managing changes in condition.
Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Body Mass Index (in Kg/m^2)
Time Frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
The Body Mass Index is a measure of body fat based on height and weight. It is calculated by a person's weight in kilograms divided by the square of height in meters.
Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Health-Promoting Lifestyle score (assessed by the Health-Promoting Lifestyle Profile-II)
Time Frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
The Health-Promoting Lifestyle Profile-II consists of 52 health-promoting behavior items that are categorized into six subscales: health responsibility, spiritual growth, physical activity, interpersonal relationships, nutrition, and stress management. Each behavior is measured from 1 (never) to 4 (regularly). The total score of the scale ranges from 52 to 208 (higher scores represents healthier lifestyles).
Two measurement timepoints: 3-month (T1) and the 6-month (T2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk assessed by the Systematic COronary Risk Evaluation (SCORE)
Time Frame: Baseline
The Systematic COronary Risk Evaluation (SCORE) is derived from a large dataset of prospective European studies and predicts fatal atherosclerotic cardiovascular events over a ten year period. This relative risk estimation (percentage) is based on the following risk factors: gender, age, smoking, systolic blood pressure and total cholesterol.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Enfermagem de Coimbra

Collaborators

Instituto Politécnico de Leiria

Investigators

  • Principal Investigator: Pedro Sousa, PhD, Nursing School of Coimbra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2023

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

December 1, 2026

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (ACTUAL)

January 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mHEART.4U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data sets that underlie results of the scientific publication will be considered for sharing with other researchers.

IPD Sharing Time Frame

Data will become available within three months after publication of the scientific report of the RCT for a period of months

IPD Sharing Access Criteria

Access criteria will be defined upon elaboration of the IPD plan and will be assessed by the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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