Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)
- Conditions
- Chronic Coronary Syndrome
- Interventions
- Device: telemonitoringOther: control follow-up
- Registration Number
- NCT05875311
- Lead Sponsor
- Catcronic Salut 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description telemonitoring 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. control follow-up 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.
- Primary Outcome Measures
Name Time Method The 6-min walk distance (6MWD) 10 months Meters (m)
- Secondary Outcome Measures
Name Time Method Non-HDL cholesterol 10 months mg/dL
Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) 10 months Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Health status obtained from the European Quality of Life questionnaire (EuroQol-5D) 10 months Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
GlycA 10 monts μmol/L
Glycosylated haemoglobin 10 months Percentage (%)
Weight 10 months Kilograms (Kg)
smoking cessation 10 months percentage
Physical activity derived from the International Physical Activity questionnaire (IPAQ) 10 months self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.
Triglycerides 10 months mg/dL
Total cholesterol 10 months mg/dL
Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire 10 months Kcal/week
Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) 10 months Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Body mass Index 10 months weight and height will be combined to report BMI (kg/m\^2)
Maximal heart rate in the six minute walk test 10 months beats per minute (bpm)
Visceral fat 10 months percentage (%)
High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire 10 months percentage
Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) 10 months Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome.
Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D) 10 months Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome.
Cost-effectiveness analysis 10 months net cost divided by changes in health outcomes
High 10 months centimeters (cm)
Percentage expected for age and sex in the six minute walk test 10 months Percentage
Neutrophil count 10 monts Neutrophils per microliter and percentage of white blood cells
Lymphocyte count 10 month Lymphocytes per microliter and percentage of white blood cells
Small LDL particles 10 months μmol/L
HDL cholesterol 10 months mg/dL
Apolipoprotein B/Apolipoprotein A-I ratio 10 months Units
Waist circumference 10 months waist circumference change (cm)
Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED). 10 months Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.
User's experience from the System Usability Scale (SUS) score 10 months Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
Leukocyte count 10 month WBCs per microliter
Platelet count 10 month Platelets per microliter
LDL cholesterol 10 months mg/dL
Trial Locations
- Locations (1)
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain