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

Chronic Coronary Syndrome Clinical Trial

— TELSINCORC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875311
• Other study ID #: TRISA-2023
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2024
• Source: Catcronic Salut SL
• Contact: Ernesto Dalli Peydró, MD
• Phone: +34626388083
• Email: ernestodallip[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Coronary Syndrome
• Syndrome

Intervention

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 are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Catcronic Salut SL

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 6-min walk distance (6MWD)	Meters (m)	10 months
Secondary	Maximal heart rate in the six minute walk test	beats per minute (bpm)	10 months
Secondary	Total cholesterol	mg/dL	10 months
Secondary	Glycosylated haemoglobin	Percentage (%)	10 months
Secondary	Weight	Kilograms (Kg)	10 months
Secondary	Waist circumference	waist circumference change (cm)	10 months
Secondary	Visceral fat	percentage (%)	10 months
Secondary	Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire	Kcal/week	10 months
Secondary	High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire	percentage	10 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	smoking cessation	percentage	10 months
Secondary	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
Secondary	Cost-effectiveness analysis	net cost divided by changes in health outcomes	10 months
Secondary	Body mass Index	weight and height will be combined to report BMI (kg/m^2)	10 months
Secondary	High	centimeters (cm)	10 months
Secondary	Percentage expected for age and sex in the six minute walk test	Percentage	10 months
Secondary	Leukocyte count	WBCs per microliter	10 month
Secondary	Neutrophil count	Neutrophils per microliter and percentage of white blood cells	10 monts
Secondary	Lymphocyte count	Lymphocytes per microliter and percentage of white blood cells	10 month
Secondary	Platelet count	Platelets per microliter	10 month
Secondary	GlycA	µmol/L	10 monts
Secondary	Small LDL particles	µmol/L	10 months
Secondary	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
Secondary	HDL cholesterol	mg/dL	10 months
Secondary	LDL cholesterol	mg/dL	10 months
Secondary	Non-HDL cholesterol	mg/dL	10 months
Secondary	Triglycerides	mg/dL	10 months
Secondary	Apolipoprotein B/Apolipoprotein A-I ratio	Units	10 months