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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Coronary Syndrome
• Intervention / Treatment: Device: telemonitoring; Other: control follow-up

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
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ernesto Dalli Peydro, MD; Phone Number: +34626388083; Email: ernestodallip@gmail.com
• Study Contact Backup: Name: Juan Cosín-Sales, MD; Phone Number: +34606338503; Email: cosin_jua@gva.es

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Recruiting
    • Hospital Arnau De Vilanova
    • Contact: Ernesto Dalli Peydro, MD; Phone Number: +34626388083; Email: ernestodallip@gmail.com
    • Contact: Juan Cosín Sales, MD; Phone Number: +34 606338044; Email: cosin_jua@gva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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
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; Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles

What is the study measuring?

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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Catcronic Salut SL
• Investigators: Principal Investigator: Ernesto Dalli Peydró, MD, Hospital Arnau de VIlanova. Valencia

Publications and helpful links

General Publications

• Dalli-Peydro E, Gisbert-Criado R, Amigo N, Sanz-Sevilla N, Cosin-Sales J. Cardiac telerehabilitation with long-term follow-up reduces GlycA and improves lipoprotein particle profile: A randomised controlled trial. Int J Cardiol. 2022 Dec 15;369:60-64. doi: 10.1016/j.ijcard.2022.08.017. Epub 2022 Aug 6.
• Dalli Peydro E, Sanz Sevilla N, Tuzon Segarra MT, Miro Palau V, Sanchez Torrijos J, Cosin Sales J. A randomized controlled clinical trial of cardiac telerehabilitation with a prolonged mobile care monitoring strategy after an acute coronary syndrome. Clin Cardiol. 2022 Jan;45(1):31-41. doi: 10.1002/clc.23757. Epub 2021 Dec 24.
• Paoli G, Notarangelo MF, Mattioli M, La Sala R, Foa C, Solinas E, Fusco S, Fava C, Caminiti C, Artioli G, Pela G, Dall'Aglio E, Manari A, Tondi S, Rizzo A, Trapolin G, Patrizi G, Cappelli S, Villani GQ, Piepoli M, Zobbi G, Nicosia E, Ardissino D. ALLiance for sEcondary PREvention after an acute coronary syndrome. The ALLEPRE trial: A multicenter fully nurse-coordinated intensive intervention program. Am Heart J. 2018 Sep;203:12-16. doi: 10.1016/j.ahj.2018.06.001. Epub 2018 Jun 12.
• Buckley BJR, de Koning IA, Harrison SL, Fazio-Eynullayeva E, Underhill P, Kemps HMC, Lip GYH, Thijssen DHJ. Exercise-based cardiac rehabilitation vs. percutaneous coronary intervention for chronic coronary syndrome: impact on morbidity and mortality. Eur J Prev Cardiol. 2022 May 25;29(7):1074-1080. doi: 10.1093/eurjpc/zwab191.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: exercise; mobile health; secondary prevention; telerehabilitation; cardiac rehabilitation; Chronic coronary syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: TRISA-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No