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

Study Overview
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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.

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.

Official Title
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Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome

Conditions
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Chronic Coronary Syndrome

Intervention / Treatment
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* Device: telemonitoring
* Other: control follow-up


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, open-label, prospective, parallel-group study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemonitoring<br>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<br>* 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<br>|
| Other: control follow-up<br>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<br>* Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 6-min walk distance (6MWD) | Meters (m) | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal heart rate in the six minute walk test | beats per minute (bpm) | 10 months | 
| Total cholesterol | mg/dL | 10 months | 
| Glycosylated haemoglobin | Percentage (%) | 10 months | 
| Weight | Kilograms (Kg) | 10 months | 
| Waist circumference | waist circumference change (cm) | 10 months | 
| Visceral fat | percentage (%) | 10 months | 
| Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire | Kcal/week | 10 months | 
| High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire | percentage | 10 months | 
| Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED). | Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome. | 10 months | 
| Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) | Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome. | 10 months | 
| Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) | Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome. | 10 months | 
| Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) | Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome. | 10 months | 
| Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D) | Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome. | 10 months | 
| Health status obtained from the European Quality of Life questionnaire (EuroQol-5D) | Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome. | 10 months | 
| smoking cessation | percentage | 10 months | 
| User's experience from the System Usability Scale (SUS) score | Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome. | 10 months | 
| Cost-effectiveness analysis | net cost divided by changes in health outcomes | 10 months | 
| Body mass Index | weight and height will be combined to report BMI (kg/m^2) | 10 months | 
| High | centimeters (cm) | 10 months | 
| Percentage expected for age and sex in the six minute walk test | Percentage | 10 months | 
| Leukocyte count | WBCs per microliter | 10 month | 
| Neutrophil count | Neutrophils per microliter and percentage of white blood cells | 10 monts | 
| Lymphocyte count | Lymphocytes per microliter and percentage of white blood cells | 10 month | 
| Platelet count | Platelets per microliter | 10 month | 
| GlycA | μmol/L | 10 monts | 
| Small LDL particles | μmol/L | 10 months | 
| Physical activity derived from the International Physical Activity questionnaire (IPAQ) | self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome. | 10 months | 
| HDL cholesterol | mg/dL | 10 months | 
| LDL cholesterol | mg/dL | 10 months | 
| Non-HDL cholesterol | mg/dL | 10 months | 
| Triglycerides | mg/dL | 10 months | 
| Apolipoprotein B/Apolipoprotein A-I ratio | Units | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health, Chronic coronary syndrome, cardiac rehabilitation, telerehabilitation, secondary prevention, exercise