Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2024-10-01

Brief Summary

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In a randomized clinical trial, a comprehensive telerehabilitation system with a prolonged follow-up strategy demonstrated superiority over a control group with centre-based cardiac rehabilitation in terms of physical activity, VO2 max, adherence to a Mediterranean diet, lipid particle profile and cost-effectiveness. The aim of this study is to demonstrate an extension of the benefit to patients with chronic coronary syndrome in primary care.

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Detailed Description

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The patients who have suffered an acute coronary event have a recurrence rate of 2.5% to 15.5% person-years during the first year. Control of cardiovascular risk factors can improve the prognosis of these patients. Following the results of a clinical trial to validate a comprehensive monitoring system called Cardioplan, with a prolonged monitoring strategy, The investigators aim to conduct a study in patients with chronic coronary syndrome in the primary care setting comparing a control group with standard follow-up and a 10-month telemonitored group. Four primary care centres will participate. Two health centres attend mainly a population with a medium-high upper socioeconomic level and the other two mainly a population with a medium-low socioeconomic level. A total of 160 subjects are expected to be included in the follow-up, with 80 subjects in each study group. The primary endpoint is to demonstrate that telemonitored follow-up improves functional exercise capacity compared to usual care, by assessing the distance in meters covered in the 6-minute walk test.

Conditions

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Chronic Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic, open-label, prospective, parallel-group study

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The characteristics of the interventions do not allow the study to be blinded either for the patient or for the professional. However, the analyses and surveys will be performed in a masked manner without the assigned group being identified by the investigators who carry out the examinations.

Study Groups

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telemonitoring

Patients in the intervention group will come to the ambulatory centre 2 times, undergoing mobile application training and the same educational talks as in the control group. Subsequently, they will follow the scheduled physical activities and adherence to the risk factor management according to individualised guidelines in their App, until the end of the study period. All data generated are recorded on the professional website. The degree of compliance with the objectives set is monitored by means of 7 coloured icons, which vary according to the target achievement.

Group Type EXPERIMENTAL

telemonitoring

Intervention Type DEVICE

The system consists of the following elements:

Professional website at the ambulatory centre, which allows:

To set up an individualised care plan To establish the patient's risk profile and targets for improvement. Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred Advise the patient on self-management strategies.

Mobile application software with the following functions:

Scheduled exercise sessions Medication reminder Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.) Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference.

Training monitor: guides the patient in the performance of their exercise. Access to certified health information for patients

control follow-up

Patients in the control group will come to the ambulatory centre only once. The same educational talks as to the intervention group will be given. A conventional outpatient follow-up by primary care and the corresponding specialist will be carried out.

Group Type OTHER

control follow-up

Intervention Type OTHER

Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles

Interventions

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telemonitoring

The system consists of the following elements:

Professional website at the ambulatory centre, which allows:

To set up an individualised care plan To establish the patient's risk profile and targets for improvement. Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred Advise the patient on self-management strategies.

Mobile application software with the following functions:

Scheduled exercise sessions Medication reminder Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.) Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference.

Training monitor: guides the patient in the performance of their exercise. Access to certified health information for patients

Intervention Type DEVICE

control follow-up

Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Patients after more than one year of an acute coronary syndrome of both sexes.
* Age equal to or less than 72 years.

Exclusion Criteria

* Refusal of informed consent
* Advanced biological age.
* Kidney failure (GFR \< 30ml/min/1.73 m2).
* Liver failure (GOT \>2 times normal value).
* Ejection fraction less than 50%.
* Uncontrolled blood pressure (\>140/90 mmHg).
* Uncontrolled heart failure.
* Dissecting aortic aneurysm.
* Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
* Aortic or mitral valve disease.
* Recent systemic or pulmonary embolism.
* Active or recent thrombophlebitis.
* Acute infectious diseases.
* Uncontrolled supraventricular arrhythmias or tachycardia.
* Repeated or frequent ventricular ectopic activity.
* Moderate pulmonary hypertension.
* Ventricular aneurysm.
* Uncontrolled diabetes, thyrotoxicosis, myxedema,
* Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
* Wolf-Parkinson-White syndrome.
* Fixed rate pacing.
* Severe anaemia.
* Psychoneurotic disorders.
* Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.

Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No