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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
160
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
Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles
Hospital Arnau de Vilanova
Valencia, Spain
RECRUITINGThe 6-min walk distance (6MWD)
Meters (m)
Time frame: 10 months
Maximal heart rate in the six minute walk test
beats per minute (bpm)
Time frame: 10 months
Total cholesterol
mg/dL
Time frame: 10 months
Glycosylated haemoglobin
Percentage (%)
Time frame: 10 months
Weight
Kilograms (Kg)
Time frame: 10 months
Waist circumference
waist circumference change (cm)
Time frame: 10 months
Visceral fat
percentage (%)
Time frame: 10 months
Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
Kcal/week
Time frame: 10 months
High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
percentage
Time frame: 10 months
Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).
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Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 months
smoking cessation
percentage
Time frame: 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.
Time frame: 10 months
Cost-effectiveness analysis
net cost divided by changes in health outcomes
Time frame: 10 months
Body mass Index
weight and height will be combined to report BMI (kg/m\^2)
Time frame: 10 months
High
centimeters (cm)
Time frame: 10 months
Percentage expected for age and sex in the six minute walk test
Percentage
Time frame: 10 months
Leukocyte count
WBCs per microliter
Time frame: 10 month
Neutrophil count
Neutrophils per microliter and percentage of white blood cells
Time frame: 10 monts
Lymphocyte count
Lymphocytes per microliter and percentage of white blood cells
Time frame: 10 month
Platelet count
Platelets per microliter
Time frame: 10 month
GlycA
μmol/L
Time frame: 10 monts
Small LDL particles
μmol/L
Time frame: 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.
Time frame: 10 months
HDL cholesterol
mg/dL
Time frame: 10 months
LDL cholesterol
mg/dL
Time frame: 10 months
Non-HDL cholesterol
mg/dL
Time frame: 10 months
Triglycerides
mg/dL
Time frame: 10 months
Apolipoprotein B/Apolipoprotein A-I ratio
Units
Time frame: 10 months