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

Catcronic Salut

Status: Enrolling

Conditions: Chronic Coronary Syndrome

Treatments: Other: control follow-up; Device: telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05875311

TRISA-2023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

160 participants in 2 patient groups

telemonitoring

Experimental group

Description:

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.

Treatment:

Device: telemonitoring

control follow-up

Other group

Description:

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.

Treatment:

Other: control follow-up