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NCT05875311 | Not yet recruiting | Chronic Coronary Syndrome


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

Catchronic Hello SL

Brief Summary:

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.

Condition or disease

Chronic Coronary Syndrome

Intervention/treatment

telemonitoring

control follow-up

Phase

Not Applicable

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 160 participants
Masking : Single
Masking Description : 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.
Primary Purpose : Prevention
Official Title : Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : October 1, 2024
Arm Intervention/treatment

Experimental: 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.

Device: telemonitoring

Other: 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.

Other: control follow-up

Ages Eligible for Study: 18 Years to 72 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.

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

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

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